Products Standard

Medical Device Standards

Products Standard (method) and number
Medical Suture Needle “Medical Suture Needle “, YY 0043-2005
Operating Knife Blade “Operating Knife Blade”, YY 0174-2005
Blade Holder “Blade Holder”, YY 0175-2005
Hospital Scissors “General Technical Requirements for Hospital Scissors “, YY/T 0176-2006
Hospital Scissors “Hospital Scissors” YY/T 0596-2006
Medical Forceps “General Technical Requirements for Medical Forceps”, YY/T 0295.1-2005
Tissue Forceps “Tissue Forceps”, YY/T 0177-2005
Needle Forceps “Needle Forceps”, YY/T 1031-2004
Non-cutting Articulated Instrument ” Surgical Instrument • General Technical Requirements for  Non-cutting Articulated Instrument”, YY/T 0687-2008
Heister’s Mouth Gag “Heister’s Mouth Gag”, YY/T 0179-2005
Stainless Steel Needle Tubing for Manufacture of Medical Devices “Stainless Steel Needle Tubing for Manufacture of Medical Devices”, GB 18457-2001
Stainless steel medical Instrument “Stainless steel medical Instrument • Corrosion Resistance Test Method”, YY/T 0149-2006
Lacrimal Probe “Lacrimal Probe”, YY 0075-2005
Lacrimal Retractor Lacrimal Retractor, YY/T 0073-2013
Eye Retractor Eye Retractor, YY/T 0180-2013
Laryngeal Forceps “General Technical Requirements for Laryngeal Forceps”, YY/T 0077-2013
Dentagra ” Dentagra”, YY/T 1021-2005
Dental Explorer Dental Explorer, YY/T 1014-2013
Dental Forceps (General Requirements) Dental Forceps-Part 1: General Requirements, YY/T 1284.1-2015
Dental Forceps (Double-bent) Dental Forceps-Part 2: Double-bent, YY/T 1284.2-2015
Dental Forceps (Single-bend) Dental Forceps-Part 3: Single-bent, YY/T 1284.3-2015
Hospital Scissors “General Technical Requirements for Hospital Scissors”, YY/T 0176-2006
Linear Cutting Stapler and Components “Linear Cutting Stapler and Components”, YY 0876-2013
Linear Stapler and Components “Linear Stapler and Components”, YY 0875-2013
Rongeur Forceps “General Technical Requirements for  Rongeur Forceps(Scissors), YY 1122-2005
Rongeur Forceps “Rongeur Forceps”, YY/T 1127-2006
External Fixation “Special Requirements for External Fixation”, YY/T 0508-2009
Metal Vaginal Dilator with Double Wings Metal Vaginal Dilator with Double Wings, YY 0006-2013
Disposable Aseptic Vaginal Dilator Disposable Aseptic Vaginal Dilator, YY 0336-2013
Cervical Biopsy Forceps Cervical Biopsy Forceps, YY 0092-2013
Cervix Forceps Cervix Forceps, YY 1023-2013
Fallopian Tube Pick-Up Hook Fallopian Tube Pick-Up Hook, YY 1024-2013
Uterine Curet Uterine Curet, YY/T 0090-2014
Uterine Probe Uterine Probe, YY/T 0172-2014
Fallopian Tube Pick-Up Plate Fallopian Tube Pick-Up Plate, YY/T 0181-2013
Perineal Scissors Perineal Scissors, YY/T 0925-2014
Aspiration Tube of Induced Abortion Aspiration Tube of Induced Abortion, YY/T 1025-2014
Uterine Cavity-shaped Intrauterine Device Uterine Cavity-shaped Intrauterine Device, GB 11234-2006
Vcu Intrauterine Uterine Device Vcu Intrauterine Uterine Device, GB 11235-2006
TCu Intrauterine Uterine Device TCu Intrauterine Uterine Device, GB 11236-2006
OCu Intrauterine Uterine Device OCu Intrauterine Uterine Device, GB 3156-2006
IUD Layup Fork IUD Layup Fork, YY/T 0183-2013
IUD  Extractive Hook IUD  Extractive Hook, YY/T 0182-2013
Vas Deferens Ligation Forceps Vas Deferens Ligation Forceps, YY/T 0184-2014
Disposable Aseptic IUD Layup Device General Requirements of Disposable Aseptic IUD Layup Device, YY/T 0886-2013
Entry Needle Entry Needle, YY/T 0282-2009
Disposable Intravenous Infusion Needle Disposable Intravenous Infusion Needle, GB 18671-2009
Disposable Aseptic Entry Needle Disposable Aseptic Entry Needle, GB 15811-2001
Disposable Anaesthesia Needle Disposable Anaesthesia Needle, YY 0321.2-2009
Disposable Aseptic Syringe Disposable Aseptic Entry Needle, GB 15810-2001
Rubber Piston for Disposable Aseptic Syringe Rubber Piston for Disposable Aseptic Syringe, YY/T 0243-2003
Disposable Insulin Syringe Disposable Aseptic Insulin Syringe, YY 0497-2005
Self-destructing Syringe Disposable Aseptic Syringe-Part 3: Self-destructive Fixed-dose Vaccine Syringe, YY 0573.3-2005
Disposable Low Resistance Syringe Disposable Low Resistance Syringe, YY/T 0909-2013
Disposable High Pressure Contrast Syringe and Attachments Disposable High Pressure Contrast Syringe and Attachments , YY 0614-2007
Lumbar Puncture Needle Lumbar Puncture Needle, YY/T 1148-2009
Prevent Reuse of Ryringes Disposable Aseptic Syringe-Part 4: Prevent Reuse of Ryringes, YY 0573.4-2010
Drug-dissolving Syringe “Disposable Syringe for dispensing”, YY/T 0821-2010
Syringes, Needles and Other Medical Devices 6% (Ruhr) Conical Joint “Syringes, Needles and Other Medical Devices 6% (Ruhr) Conical Joint -Part 2: Locking Joint” , GB/T 1962.2-2001
Identification of Color Code of Disposable Entry Needle “Identification of Color Code of Disposable Entry Needle”, YY/T 0296-2013 2
Medical Devices 6% (Ruhr) Conical Joint Syringes, Needles and Other Medical Devices 6% (Ruhr) Conical Joint -Part 1: General Requirements, GB/T 1962.1-2015
Disposable Arteriovenous Puncture Device Disposable Arteriovenous Puncture Device, YY/T 0328-2015
Medical Needle-free Syringe Medical Needle-free Syringe-Requirements and Test Methods, YY/T 0907-2013
Thermometer “Glass Thermometer”, GB 1588-2001
Stethophone “Stethophone”, YY 91035-1999
Sphygmomanometer “Sphygmomanometer”, GB 3053-1993
Endoscopic Instruments “Endoscopic Instruments-Part 1”, YY 0672.1-2008
Care Products for Contact Lens “Opticianry • Care Products for Contact Lens-Part 4:Antimicrobial Preservative Effectiveness Test and Measurement Abandon Date Guide”, YY 0719.4-2009 5
Care Products for Contact Lens “Opticianry • Care Products for Contact Lens-Part 3: Microbiological Requirements and Test Methods and Contact Lens Care Systems”, YY 0719.3-2009 5
Disposable Venous Blood Sample Collection Container (Blood Collection Device) “Disposable Venous Blood Sample Collection Container”, YY 0314-2007
Disposable Human Peripheral Blood Sample Collection Container “Disposable Human Peripheral Blood Sample Collection Container”, YY/T 0617-2007
Plasma Pipeline “Disposable Centrifugal Plasma Separator-Part 2: Plasma Pipeline”, YY 0326.2-2002
Disposable Blood Products “General Technical Requirements for Disposable Blood Products”, GB 19335-2003
Disposable Centrifugal Plasma Separation Cup “Disposable Centrifugal Plasma Separator-Part 1: Plasma Separation Cup”, YY 0326.1-2002
Disposable Centrifugal Cup Blood Component Separator “Disposable Centrifugal Cup Blood Component Separator”, YY 0584-2005
Disposable Liquid Circuit for Pressure Infusion Device and Its Attachments (Backflow Preventer) “Disposable Liquid Circuit for Pressure Infusion Device and Its Attachments-Part 4: Backflow Preventer”,YY 0585.4-2009
Disposable Liquid Circuit for Pressure Infusion Device and Its Attachments (Filter) “Disposable Liquid Circuit for Pressure Infusion Device and Its Attachments-Part 3: Filter”,YY 0585.3-2005
Disposable Liquid Circuit for Pressure Infusion Device and Its Attachments (Fluid Pipe) “Disposable Liquid Circuit for Pressure Infusion Device and Its Attachments-Part 1: Fluid Pipe”,YY 0585.1-2005
Disposable Liquid Circuit for Pressure Infusion Device and Its Attachments “Disposable Liquid Circuit for Pressure Infusion Device and Its Attachments-Part 2: Attachments”,YY 0585.2-2005
Metal Shaped Bone Fracture Plate “Bone Joint Implants • Metal  Bone Fracture Plate”, YY 0017-2008
Metal Straight Bone Fracture Plate “Bone Joint Implants • Metal  Bone Fracture Plate”, YY 0017-2008
Metal Bone Screw “Bone Joint Implants • Metal Bone Screw”, YY 0018-2008
Metal Orthopedic Nail “Bone Joint Implants • Metal Orthopedic Nail”, YY 0119-2002
Metal Orthopedic Rod “Bone Joint Implants • Metal Orthopedic Rod”, YY 0120-2002
Stainless Steel for Surgical Implants “Stainless Steel for Surgical Implants”, GB 4234-2003 6.5
Surgical Implants • Intramedullary Nailing System “Surgical Implants • Intramedullary Nailing System-Part 1: Intramedullary Nail with A Trilobal or V-shaped Cross Section”, YY/T 0019.1-2011
Surgical Implants • Intramedullary Nailing System “Surgical Implants • Intramedullary Nailing System-Part 2: Intramedullary Nail”, YY/T 0019.2-2011
Determination of Flexural Strength and Stiffness of Bone Plates “Surgical Implants • Determination of Flexural Strength and Stiffness of Bone Plates”, YY/T 0342-2002
Surgical Implants • Asymmetric Thread and Metal Bone Screw on the Lower Surface of the Sphere “Surgical Implants • Asymmetric Thread and Metal Bone Screw on the Lower Surface of the Sphere-Mechanical Performance Requirements and Rest Methods”, YY/T 0662-2008
Passive Surgical Implant-Cardiac and Vascular Implants “Passive Surgical Implant- Special Requirements of Cardiac and Vascular Implants: Special Requirements for Arterial Atents”, YY/T 0663-2008
Intravascular Stent “Cardiovascular Implant • Intravascular Device-Part 2: Intravascular Stent”, IS0 25539-2:2012
Intravascular Stent “Standard Test Method for in Vitro Pulsation Durability of Vascular Stents”, YY/T 0808-2010
Intravascular Stent “Guide to Finite Element Method for Metal Stents under Uniform Radial Load”, YY/T 0859-2011
Metal Bone Needle “Surgical Implants • Metal Bone Needle-Part 1: Requirements for Materials and Mechanical Properties”, YY/T 0345.1-2011 4
Balloon-expandable Stents “Three-point Bending Test Method for Balloon-expandable Vascular Stent and Its System”, YY/T 0858-2011
Bone Joint Implants(Metal Femoral Neck Fixation Nail) Bone Joint Implants • Metal Femoral Neck Fixation Nail, YY 0346-2002
Bone Fracture Plate “Surgical Implants • Determination of Flexural Strength and Stiffness of Bone Plates”, YY/T 0342-2002
Metal Bone Needle(Steinmann Needle) “Surgical Implants • Metal Bone Needle-Part 2: Size of Steinmann Needle”, YY/T 0345.2-2014 2
Metal Bone Needle(Kirschner Needle) “Surgical Implants • Metal Bone Needle-Part 3: Kirschner Needle”, YY/T 0345.3-2014 3
Bone Joint Implants(Metal Interlocking Nail) Bone Joint Implants • Metal Interlocking Nail, YY/T 0591-2011
Endovascular Prosthesis “Cardiovascular Implant • Intravascular Device-Part 1: Endovascular Prosthesis”,YY/T 0663.1-2014
Size and Feature of Intravascular Stent Characterization of Size and  Feature of Intravascular Stent, YY/T 0693-2008
Balloon-expandable Stents’ Elastic Retraction Standard Test Method for Balloon-expandable Stents’ Elastic Retraction, YY/T 0694-2008
Stabilization of Balloon-expandable Stents Preloaded on Delivery Systems Standard Test Method for Stabilization of Balloon-expandable Stents Preloaded on Delivery Systems, YY/T 0807-2010
Infusion Pump Disposable Infusion Pump • Non-electric Drive, YY 0451-2010
Dental Alginate Impression Material “Dental Alginate Impression Material”, YY 1027-2001
Root Canal Filling Tip Root Canal Filling Tip, YY 0495-2009
Dental Casting Wax Dental Casting Wax, YY 0496-2004
Titanium and Titanium Alloy Artificial Dental Implants Titanium and Titanium Alloy Artificial Dental Implants, YY 0315-2008
Dentistry Elastomer Impression Material Dentistry Elastomer Impression Material, YY 0493-2011
Dental Agar-based Hydrocolloid Impression Material Dental Agar-based Hydrocolloid Impression Material, YY 0494-2004
Dental Casting Gold Alloys Dentistry • Casting Gold Alloys, YY 0620-2008
Dental Orthodontic Elastomer Attachments Dentistry • Orthodontic Products: Orthodontic Elastomer Attachments, YY 0624-2008
Dental Orthodontic Wire Dentistry • Orthodontic Products: Orthodontic Wire, YY 0625-2008
Dental Base/ Model Wax Dental Base/ Model Wax, YY 1070-2008
Orthodontic Wire Dentistry • Orthodontic Products: Orthodontic Wire, YY 0625-2008
Medical Protective Clothing Medical Disposable Protective Clothing Technical Tequirements, GB 19082-2009
Medical Protective Mask Medical Protective Mask Technical Tequirements, GB 19083-2010
Medical Absorbent Cotton Performance Requirements and Test Methods for Absorbent Cotton and Sbsorbent Cotton Viscose Blended Gauze, YY 0331-2006
Medical Adhesive Plaster (Medical Tape) General Requirements of Medical Tape, YY/T 0148-2006
Surgical Gauze Dressing General Requirements of Surgical Gauze Dressing, YY 0594-2006
Medical Surgical Mask Medical Surgical Mask, YY 0469-2011
Surgical Sheets, Surgical Clothing and Cleaning Clothing for Patients, Medical Staff and Instruments Surgical Sheets, Surgical Clothing and Cleaning Clothing for Patients, Medical Staff and Instruments-Part 3: Test Method, YY/T 0506.3-2005
Surgical Sheets, Surgical Clothing and Cleaning Clothing for Patients, Medical Staff and Instruments Surgical Sheets, Surgical Clothing and Cleaning Clothing for Patients, Medical Staff and Instruments-Part 4: Test Method, YY/T 0506.4-2005
Surgical Sheets, Surgical Clothing and Cleaning Clothing for Patients, Medical Staff and Instruments Surgical Sheets, Surgical Clothing and Cleaning Clothing for Patients, Medical Staff and Instruments-Part 6: Wet-proof Microbial Penetration Test Method, YY/T 0506.6-2009
Bacterial Resistance of Contact Wound Dressing Test Method of Contact Wound Dressing-Part 5: Bacterial Resistance, YY/T 0471.5-2004
Sodium Hyaluronate Tissue engineering medical products-Part 9: Sodium Hyaluronate, YY/T 0606.9-2007
Medical Sodium Hyaluronate Gel Medical Sodium Hyaluronate Gel, YY/T 0308-2015
Medical Absorbent Cotton Medical Absorbent Cotton, YY/T 0330-2015
Non-absorbable Surgical Suture Non-absorbable Surgical Suture, YY 0167-2005
Absorbable Surgical Suture Absorbable Surgical Suture, YY 1116-2010
Line of Suture Needle Line of Suture Needle, YY 0166-2002
Anastomat/Stiching Instrument “General Technical Requirements for  Anastomat/Stiching Instrument, YY/T 0245-2008
Purse Suture Needle Purse Suture Needle, YY 0877-2013
Tracheal Intubation Tracheal Intubation-Part 1: Commonly Used Cannula and Connector, YY 0337.1-2002/ISO 5361:1999
Tracheal Intubation Tracheal Intubation-Part 2: Cole Cannula, YY 0337.2-2002/ISO 5361-4:1987
Tracheotomy Tube Tracheotomy Tube-Part 1: Cannula and Connector for Adult, YY 0338.1-2002/ISO 5366-1:2000
Tracheotomy Tube Tracheotomy Tube-Part 2: Tracheotomy Tube for Child, YY 0338.2-2002/ISO 5366-3:2001
Disposable Aseptic Intravascular Catheter Disposable Aseptic Intravascular Catheter-Part 1: General Requirements, YY 0285.1-2004/ISO 10555-1:1995
Disposable Aseptic Intravascular Catheter Disposable Aseptic Intravascular Catheter-Part 2: Angiographic Catheter, YY 0285.2-1999/ISO 10555-2:1996
Disposable Aseptic Intravascular Catheter Disposable Aseptic Intravascular Catheter-Part 3: Central Venous Catheter, YY 0285.3-1999/ISO 10555-3:1996
Disposable Aseptic Intravascular Catheter Disposable Aseptic Intravascular Catheter-Part 4: Balloon-expandable Catheter, YY 0285.4-1999/ISO 10555-4:1996
Disposable Aseptic Intravascular Catheter Disposable Aseptic Intravascular Catheter-Part 5: Needle Peripheral Catheter, YY 0285.5-2004/ISO 10555-5:1996
Disposable Aseptic Intravascular Catheter Disposable Aseptic Intravascular Catheter Attachments-Part 1: Guiding Device, YY 0450.1-2003
Disposable Anesthesia Puncture Package Disposable Anesthesia Puncture Package, YY 0321.1-2009
Disposable Anesthesia Filter Disposable Anesthesia Filter, YY 0321.3-2009
Disposable Infusion Set Disposable Infusion Set • Gravity Infusion, GB 8368-2005
Disposable Blood Transfusion Device Disposable Blood Transfusion Device, GB 8369-2005
Disposable Burette Type Infusion Set Special Infusion Sets-Part 2: Disposable Burette Type Infusion Set• Gravity Infusion, YY 0286.2-2006/ISO 8536-5:2004
Urethral Catheter Disposable Aseptic Urethral Catheter, YY 0325-2002
Suction Catheter for Respiratory Tract Suction Catheter for Respiratory Tract, YY 0339-2009
Breathing Tube Breathing Tube for Anesthesia Machine and and Ventilator, YY 0461-2003
Condom Technical Requirements and Test Methods of Natural Latex Rubber Condoms, GB 7544-2009
Heparin Caps for Infusion “Heparin Caps for Infusion”, YY 0581-2005
Disposable Infusion Set with Precise Filter “Special Infusion Sets-Part 1: Disposable Infusion Set with Precise Filter”, YY 0286.1-2007
Disposable Bottle and Bag Infusion Set “Special Infusion Sets-Part 5: Disposable Bottle and Bag Infusion Set”, YY 0286.5-2008
Disposable Intravenous Nutrition Infusion Bag “Disposable Intravenous Nutrition Infusion Bag”, YY 0611-2007
Disposable Human Arterial Blood Sample Collector (Arterial Blood Gas Needle) “Disposable Human Arterial Blood Sample Collector (Arterial Blood Gas Needle)”, YY 0612-2007
Disposable Centrifugal Bag Blood Component Separator “Disposable Centrifugal Bag Blood Component Separator”, YY 0613-2007
Disposable Flow Setting Fine-tuning Infusion Set “Special Infusion Sets-Part 6: Disposable Flow Setting Fine-tuning Infusion Set, YY 0286.6-2009
Urine Collection Bags “Urine Collection Bags-Part 2: Requirements and Test Methods”, GB/T 17257.2-2009
Plastic Blood/Plasma Bag Extract Chemical Limit (Ammonium, Chlorine, Aluminum, Alcohol Dissolution, etc.) “Disposable Centrifugal Cup Blood Component Separator”, YY 0584-2005
Plastic Blood/Plasma Bag Extract Chemical Limit (Ammonium, Chlorine, Aluminum, Alcohol Dissolution, etc.) “Disposable Intravenous Nutrition Infusion Bag”, YY 0611-2007
Medical Mask (resistant to blood penetration) “Infectious Pathogen Protective Equipment Medical Mask Anti-synthetic Blood Penetration Test Method (Fixed Volume, Horizontal Jet)”, YY/T 0691-2008
Infusion Connector: Puncture Connector (Heparin Cap) “Infusion Connector-Part 1: Puncture Connector (Heparin Cap), YY0581.1-2011
Disposable Injection Filter Disposable Injection Filter, YY/T 0908-2013
Non-endovascular Catheter Non-endovascular Catheter-Part 1: General Performance Test Method, GB/T 15812.1-2005
Cervical Dilator Cervical Dilator, YY 0091-2013
Disposable Chest Drainage Device (Water-sealed Type) Disposable Chest Drainage Device-Part 1: Water-sealed Type, YY/T 0583.1-2015
Balloon Inflation Device for Balloon-expandable Catheter Disposable Aseptic Intravascular Catheter Attachments-Part 3: Balloon Inflation Device for Balloon-expandable Catheter, YY 0450.3-2007
Medical Device (Hemolysis) Test Methods for Medical Infusions, Blood Transfusions and Injecting Machines-Part 2: Biological Test Method, GB 14233.2-2005 7
Medical Device (Hemolysis) Experimental Method for Biological Evaluation of Medical Silicone Materials, GB 16175-2008 13
Medical Device (Hemolysis) Biological Evaluation of Medical Device-Part 4: Blood Interaction Test Selection, GB 16886.4-2003 C6
Medical Device (Hemolysis) Oral Material Biological Experiment Method • Hemolysis Experiment, YY/T 0127.1-1993
Hygiene Products (Microorganisms) Hygienic Standard for Disposable Hygiene Products, GB 15979-2002
Medical Device(Chemistry) Test Methods for Medical Infusions, Blood Transfusions and Injecting Machines-Part 1: Chemical Analysis Method, GB/T 14233.1-2008
Surgical Metal Implants General Technical Requirements for Passive Surgical Metal Implants for Bone Cementation, YY 0341-2009
Medical Device(Chemistry) “Silicone Rubber Pipe and Elastic Parts for Infusion and Blood Transfusion”, YY/T 0031-2008
Medical Device(Cytotoxicity) Test Methods for Medical Infusions, Blood Transfusions and Injecting Machines-Part 2: Biological Test Method, GB/T 14233.2-2005
Medical Device(Cytotoxicity) Biological Evaluation of Medical Device-Part 5: In Vitro Cytotoxicity Test, GB/T 16886.5-2003
Soft PVC Pipe Medical Use “Soft PVC Pipe Medical Use”, GB 10010-2009
Medical Device(Bacterial Endotoxin) Medical Device Bacterial Endotoxin (Gel Method) “Four Chinese Pharmacopoeia 2015 Edition (General Rule 1143)” “Test Methods for Medical Infusions, Blood Transfusions and Injecting Machines-Part 2: Biological Test Method”, GB/T 14233.2-2005
Medical Device(Aseptic) Medical Device(Aseptic) “Four Chinese Pharmacopoeia 2015 Edition (General Rule 1101)” “Test Methods for Medical Infusions, Blood Transfusions and Injecting Machines-Part 2: Biological Test Method”, GB/T 14233.2-2005
Medical Device(Aseptic) “Sanitary Standards for Disposable Medical Supplies” GB 15980-1995, Appendix D of GB15980-1995, GB/T 14233.2-2005 Chapter 3 and 2010 Pharmacopoeia Appendix XI H
Surgical Implant (Liquid Penetration) “Liquid Penetration Test for Surgical Metal Implants, YY/T 0343-2002 3
Small Implant Device “Standard Test Method for Cyclic Potent Potential Polarization of Corrosion Sensitivity of Small Implants”, YY/T 0695-2008
Stainless Steel Products for Surgical Implants “Pitting Potential of Stainless Steel Products for Surgical Implants”, YY/T 1074-2004
Ultrahigh Molecular Weight Polyethylene(Melting Enthalpy, Crystallinity and Melting point) “Determination of Melting Enthalpy, Crystallinity and Melting Point of Ultrahigh Molecular Weight Polyethylene by Differential Scanning Calorimetry”, YY/T 0815-2010
Medical Devices (Pyrogen) “Test Methods for Medical Infusions, Blood Transfusions and Injecting Machines-Part 2: Biological Test Method(New Version)”, GB/T 14233.2-2005 5.1-5.6
Medical Devices (Stimulation) “Biological Evaluation of Medical Device-Part 10: Stimulation and Delayed Hypersensitivity Test”,”Test Methods for Medical Infusions, Blood Transfusions and Injecting Machines-Part 2: Biological Test Method(New Version)”, GB/T 16886.10-2005、GB/T 14233.2-2005 6.3
Medical Devices (Delayed Hypersensitivity) Biological Evaluation of Medical Device-Part 10: Stimulation and Delayed Hypersensitivity Test, GB/T 16886.10-2005 7
Medical Devices (Delayed Hypersensitivity) “Test Methods for Medical Infusions, Blood Transfusions and Injecting Machines-Part 2: Biological Test Method”, GB/T 14233.2-2005 9
NiTi Alloy (Phase Transition Temperature) Standard Method for Measuring Phase Transition Temperature of NiTi Alloy by Thermal Analysis, YY/T 0641-2008
Liquid/Blood Circuit Needleless Interface Liquid/Blood Circuit Needleless Interface ▪ Microbial Invasion Test Method, YY/T 0923-2014
Polyvinyl Chloride Medical Devices(DEHP Quantitative) Quantitative Analysis of Di(2-ethylhexyl) Phthalate (DEH) in Medical Polyvinyl Chloride Medical Devices, YY/T 0926-2014
Polyvinyl Chloride Medical Devices(DEHP Dissolution) Guide for the Determination of the Dissolution Date of Di(2-ethylhexyl) Phthalate (DEHP) in Polyvinyl Chloride Medical Devices, YY/T 0927-2014
Medical Devices(Microbial Limit) “Four Chinese Pharmacopoeia 2015 Edition (General Rule 1105,1106)”,
Disposable Medical Mask “Disposable Medical Mask”, YY/T 0969-2013
Medical Devices(Acute Systemic Toxicity) “Test Methods for Medical Infusions, Blood Transfusions and Injecting Machines-Part 2: Biological Test Method(New Version)”, GB/T 14233.2-2005 2
Medical Devices(Acute Systemic Toxicity) Biological Evaluation of Medical Device-Part 11: Systemic Toxicity Test, GB/T 16886.11-2011 2
Liquid Filtration Membrane, Liquid Filter (Bacteria Retention) Test Methods for Liquid Filtration Membrane, Liquid Filter (Bacteria Retention), YY/T 0918-2014
Liquid Filter Sterilization filter for infusions-Part 1: Liquid Filter Integrity Test, YY/T 0929.1-2014
Medical Electrical Equipment “Medical Electrical Equipment Part 1-2: General Requirements for Safety Parallel Standard: Electromagnetic Compatibility Requirements and Tests”, YY 0505-2012
Medical Electrical Equipment “Medical Electrical Equipment Part 1-2: General Requirements for Safety Parallel Standard: Electromagnetic Compatibility Requirements and Tests”, IEC 60601-1-2:2007
Electrical and Electronic Equipment “Electromagnetic Compatibility Limit Harmonic Current Emission Limit (Device Input Current Per Phase ≤ 16A)”,GB 17625.1-2012
Electrical and Electronic Equipment “Electromagnetic Compatibility Limits for Voltage Variations, Voltage Fluctuations and Flickering in Common Low-voltage Power Supply Systems for Equipment with Rated Current ≤16A Per Phase and Pnconditionally Ponnected”, GB 17625.2-2007
Electrical and Electronic Equipment “Electromagnetic Compatibility Test and Measurement Technology • Electrostatic Discharge Immunity Test”, GB/T 17626.2-2006
Electrical and Electronic Equipment “Electromagnetic Compatibility Test and Measurement Technology • Radio Frequency Electromagnetic Field Radiation Immunity Test”, GB/T 17626.3-2006
Electrical and Electronic Equipment “Electromagnetic Compatibility Test and Measurement Technology • Electrical Fast Transient Burst Immunity Test”, GB/T 17626.4-2008
Electrical and Electronic Equipment “Electromagnetic Compatibility Test and Measurement Technology • Surge (Impact) Immunity Test”, GB/T 17626.5-2008
Electrical and Electronic Equipment “Electromagnetic Compatibility Test and Measurement Technology • Conducted Disturbance Immunity of RF Field Induction”, GB/T 17626.6-2008
Electrical and Electronic Equipment “Electromagnetic Compatibility Test and Measurement Technology • Power Frequency Magnetic Field Immunity Test”, GB/T 17626.8-2006
Electrical and Electronic Equipment “Electromagnetic Compatibility Test and Measurement Technology • Immunity Test for Voltage Dips, Short Interruptions and Voltage Changes”, GB/T 17626.11-2008
Electrical and Electronic Equipment “Electromagnetic Compatibility Test and Measurement Technology • Electrostatic Discharge Immunity Test”, IEC 61000-4-2:2008
Electrical and Electronic Equipment “Electromagnetic Compatibility Test and Measurement Technology • Electrical Fast Transient Burst Immunity Test”, IEC 61000-4-4:2012
Electrical and Electronic Equipment “Electromagnetic Compatibility Test and Measurement Technology • Power Frequency Magnetic Field Immunity Test”, IEC 61000-4-8:2009
Audiphone Electroacoustics Audiphone-Part 13: Electro Magnetic Compatibility (EMC), IEC 60118-13:2011 5
Audiphone Electroacoustics Audiphone-Part 14: Electro Magnetic Compatibility (EMC), GB/T 25102.13-2010 5
Electrical Equipment for Measurement, Control and Laboratory Use “Electromagnetic Compatibility Requirements for Electrical Equipment for Measurement, Control and Laboratory Use-Part 1: General Requirements”, GB/T 18268.1-2010
Electrical Equipment for Measurement, Control and Laboratory Use “Electromagnetic Compatibility Requirements for Electrical Equipment for Measurement, Control and Laboratory Use-Part 26: Special Requirements for In Vitro Diagnostic (IVD) Medical Equipment”, GB/T 18268.26-2010
Household Appliances, Power Tools and Similar Appliances “Electromagnetic Compatibility Requirements for Household Appliances, Power Tools and Similar Appliances-Part 1: Emission”, GB 4343.1-2009
Household Appliances, Power Tools and Similar Appliances “Electromagnetic Compatibility Requirements for Household Appliances, Power Tools and Similar Appliances-Part 2: Immunity”, GB 4343.2-2009
Industrial, Scientific, and Medical (ISM) RF Equipment “Limits and Methods of Measurement of Electromagnetic Disturbance Characteristics for Industrial, Scientific and Medical (ISM) Radio Frequency Equipment”, GB 4824-2013
Information Technology Tquipment “Radio Disturbance Limits and Methods of Measurement for Information Technology Equipment”, GB 9254-2008
Electrical Lighting and Similar Equipment “Limits and Methods of Measurement of Radio Disturbance Characteristics for Electrical Lighting and Similar Equipment”, 17743-2007
Implantable Neurostimulator “Surgical Implants • Active Implantable Medical Devices-Part 3: Implantable Neurostimulator”, ISO 14708-3:2008
Active Implantable Medical Device for Treating Tachyarrhythmia “Surgical Implants • Active Implantable Medical Devices-Part 6: Special Requirements for Active Implantable Medical Devices (Including Implantable Defibrillators) for the Treatment of Tachyarrhythmia”, YY 0989.6-2016/IS0 14708-6:2010
Cochlear Implant System “Surgical Implants • Active Implantable Medical Devices-Part 7: Special Requirements for Cochlear Implant Systems”, IS0 14708-7:2013
Medical Electrical Equipment “Medical Electrical Equipment-Part 1: General Requirements for Safety”, GB 9706.1-2007/IEC 60601-1:1988+A1:1991+A2: 1995
Medical Electrical Equipment “Medical Electrical Equipment-Part 1-1: General Requirements for Safety 1. Parallel: Safety Requirements for Medical Electrical Systems”,GB 9706.15-2008/IEC 60601-1-1:200
Medical Electrical Equipment Requirements and Rest Methods for Medical Electrical Environment, GB/T 14710-2009
Medical Electrical Equipment “Medical Electrical Equipment-Part 1: General Requirements for Safety”, IEC 60601-1:2005
Medical Electrical Equipment-Part 1-4: General Requirements for Safety: Programmable Medical Electrical System “Medical Electrical Equipment-Part 1-4: General Requirements for Safety: Programmable Medical Electrical System”, YY/T 0708-2009
Medical Electrical Equipment-Part 1-8: Parallel to Safety General Requirements: General requirements, Testing and Guidance for Alarm Systems in Medical Electrical Equipment and Medical Electrical Systems “Part 1-8: Parallel: Testing and Guidance for Alarm Systems in Medical Electrical Equipment and Medical Electrical Systems”, YY 0709-2009
Medical Electrical Equipment Medical Electrical Equipment • Periodical Testing and Post-repair Testing of Medical Electrical Equipment, YY/T 0841-2011
Electrical Equipment for Measurement, Control and Laboratory Use “Safety Requirements of Electrical Equipment for Measurement, Control and Laboratory Use-Part 1: General Requirements”, GB 4793.1-2007/IEC 61010-1:2001
Information Technology Equipment Security Information Technology Equipment Securityt-Part 1: General Requirements, GB 4943.1-2011/IEC 60950-1-2005
ECG Monitor “ECG Monitor”, YY1079-2008
ECG Monitor “Medical Electrical Equipment-Part 2: Special Requirements for Safety of ECG Monitoring Equipment”, GB 9706.25-2005/IEC 60601-2-27:1994
ECG Monitor “Medical Electrical Equipment-Part 2-30: Automatic Cycle Non-invasive Blood Pressure Monitoring Equipment Safety Special Requirements and Basic Performance”, IEC 60601-2-30:1999
Invasive Blood Pressure Monitoring Equipment Medical Electrical Equipment-Part 2-34: Special Requirements for Safety and Basic Performance of Invasive Blood Pressure Monitoring Equipment, IEC 60601-2-34:2000
Multi-parameter Patient Monitor “Medical Electrical Equipment-Part 2-49: Safety Specific Requirements for Multi-function Patient Monitoring Equipment”, IEC 60601-2-49:2001
Cardiac Defibrillator and Cardiac Defibrillator Monitor “Medical Electrical Equipment-Part 2-4: Safety Requirements for Cardiac Defibrillators”, GB 9706.8-2009
Multi-parameter Patient Monitoring Equipment “Medical Electrical Equipment-Part 2-49: Safety Specific Requirements for Multi-function Patient Monitoring Equipment”, YY 0668-2008
ECG Monitor Cable and Lead Wire “ECG Monitor Cable and Lead Wire”, YY 0828-2011
Electrocardiograph “ECG Diagnostic Equipment”, YY 1139-2013
Electrocardiograph “Electrocardiograph”, JJG 543-2008
Electrocardiograph “Medical Electrical Equipment-Part 2: Special Requirements for ECG Machine Safety”, GB 10793-2000
Electrocardiograph “Medical Electrical Equipment-Part 2: Special Requirements for ECG Machine Safety”, IEC 60601-2-25:1993+A1:1999
Dynamic Electrocardiogram System “Medical Electrical Equipment-Part 2: Dynamic ECG System Safety and Basic Performance Specific Requirements”, YY 0885-2013
Recording and Analysis Type Single and Multi-channel Electrocardiograph “Medical Electrical Equipment-Part 2-51: Recording and Analysis Specific Requirements for Single and Multi-channel Electrocardiograph Safety and Basic Performance”, YY 0782-2010
Disposable Electrocardiogram Electrode “Disposable Electrocardiogram Electrode”, YY/T 0196-2005
Automatic Cycle Non-invasive Blood Pressure Monitoring Device “Medical Electrical Equipment-Part 2-30: Special Requirements for Safety and Basic Performance of Automatic Cycling Non-invasive Blood Pressure Monitoring Equipment”, YY 0667-2008
Non-invasive Automated Sphygmomanometer “Medical Electrical Equipment-Part 2-30: Special Requirements for Safety and Basic Performance of Automatic Cycling Non-invasive Blood Pressure Monitoring Equipment”, YY 0670-2008
Blood Pressure Sensor Blood Pressure Sensor, YY 0781-2010
Invasive Blood Pressure Monitoring Equipment Medical Electrical Equipment-Part 2-34: Special Requirements for Safety and Basic Performance of Invasive Blood Pressure Monitoring Equipment, YY 0783-2010
Medical Pulse Oximeter Equipment Medical Electrical Equipment • Specific Requirements of Basic Safety and Main Performance for Medical Pulse Oximeter Equipment, YY 0784-2010
EEG Machine “Cardiogram Machine”, JJG954-2000
EEG Machine Medical Electrical Equipment-Part 2: Special Requirements for ECG Machine Safety, GB 9706.26-2005
Temperature Biofeedback Equipment “Temperature Biofeedback Equipment”, YY/T 1096-2007
Myoelectric and Evoked Response Equipment Medical Electrical Equipment-Part 2: Special Requirements for the Safety of Myoelectric and Evoked Response Equipment, YY 0896-2013
Myoelectric Biofeedback Equipment Myoelectric Biofeedback Equipment, YY/T 1095-2015
Direct Impedance Blood Flow Recorder “Direct Impedance Blood Flow Recorder”, YY/T 1078-2008
Bridge Impedance Blood Flow Recorder “Bridge Impedance Blood Flow Recorder”, YY/T 1143-2008
Pacemaker “Surgical Implants • Active Implantable Medical Devices-Part 1: General Requirements for Safety, Mark and Information Provided By the Manufacturer”, ISO 14708-1:2000
Pacemaker “Surgical Implants • Active Implantable Medical Devices-Part 2: Cardiac Pacemaker”, ISO 14708-2:2005
Implantable Cardiac Pacemaker “Cardiac Pacemaker-Part 1: Implantable Cardiac Pacemaker”, GB 16174.1-1996/ISO 5841-1:1989
Small Section Connector for Implantable Cardiac Pacemakers “Cardiac Pacemaker • Small Section Connector for Implantable Cardiac Pacemakers”, YY/T 0491-2004/ISO 5841-3:2000
Electrode catheter for Implantable Cardiac Pacemaker “Electrode catheter for Implantable Cardiac Pacemaker”, YY/T 0492-2004
DF-1 Connector Assembly for Cardiac Defibrillators, Implantable Cardiac Defibrillators Dimensions and Test Requirements for DF-1 Connector Assembly for Cardiac Defibrillators, Implantable Cardiac Defibrillators, YY/T 0946-2014
Implantable Neurostimulator “Surgical Implants • Active Implantable Medical Devices-Part 3: Implantable Neurostimulator”, ISO 14708-3:2008
Cochlear Implant System “Surgical Implants • Active Implantable Medical Devices-Part 7: Special Requirements for Cochlear Implant Systems”, ISO 14708-7:2013
External Cardiac Pacemaker Medical Electrical Equipment-Part 2: Special Requirements for External Cardiac Pacemaker Safety With Internal Power Supply, YY 0945.2-2015
Airbag Type External Counterpulsation Device “Airbag Type External Counterpulsation Device”, GB 10035-2006
Low Frequency Electronic Pulse Therapy Device Medical Electrical Equipment-Part 2: Special Requirements for Nerve and Muscle Stimulator Safety, YY 0607-2007/IEC 60601-2-10:1987
Low Frequency Electronic Pulse Therapy Device Medical Electrical Equipment-Part 3: Special Requirements for Nerve and Muscle Stimulator Safety, IEC 60601-2-10:1987+A1:2001
Medium Frequency Electrotherapy Medical Electrical Equipment-Part 4: Special Requirements for Nerve and Muscle Stimulator Safety, YY 0607-2007/IEC 60601-2-10:1987
Electroacupuncture Treatment Instrument “Electroacupuncture Treatment Instrument”, YY0780-2010
Musical Electrotherapy Medical Electrical Equipment-Part 4: Special Requirements for Nerve and Muscle Stimulator Safety, YY 0607-2007/IEC 60601-2-10:1987
Nerve and Muscle Stimulator “Measurement of Output Characteristics of Nerve and Muscle Stimulators”, YY/T 0696-2008
Multi-function Therapeutic Device Electrodes of Electromagnetic and Muscle Stimulator, YY 0868-2011
Microwave Therapy Equipment Medical Electrical Equipment-Part 2: Special Requirements for Microwave Therapy Equipment, GB 9706.6-2007
High Voltage Potential Therapy Device “High Voltage Potential Therapy Device”, YY 0649-2008
Medical Heating Pad Therapy Equipment “Medical Heating Pad Therapy Equipment”, YY 0165-2007
Thermal Radiation Therapy Device “Special Requirements for Thermal Radiation Therapy Equipment”, YY 0306-2008
Infrared Treatment Equipment “Special Requirements for Infrared Treatment Equipment”, YY 0323-2008
Ultraviolet Treatment Equipment “Ultraviolet Treatment Equipment”, YY 0901-2013
Liquid Nitrogen Cryosurgical Equipment “Liquid Nitrogen Cryosurgical Equipment”, YY 0677-2008
Medical Cryosurgical Equipment Performance and Safety of Medical Cryosurgical Equipment, YY 0678-2008
Electric Pad Medical Electrical Equipment-Part 2: Special Requirements for the Safety of Medical Electric Blankets, Electric Heating Pads and Electric Mattresses, YY 0834-2011
Medical Temperature Control Blanket Medical Temperature Control Blanket, YY 0952-2015
Extracorporeal Shock Wave Lithotripter “Technical Requirements for In Vitro Initiation of Crushed Stone Equipment”, YY 0001-2008
Extracorporeal Shock Wave Lithotripter Medical Electrical Equipment-Part 2: Special Requirements for Safety of In Vitro Initiation of Crushed Stone Equipment, GB 9706.22-2003
Extracorporeal Pressure Wave Therapy Equipment Pneumatic Ballistic Extracorporeal Pressure Wave Therapy Equipment, YY 0950-2015
Air Pulse System ” Limb Compression Therapy Equipment”, YY 0833-2011
Clinical Electronic Thermometer “Clinical Electronic Thermometer”, GB/T 21416-2008
Clinical Thermometer “Clinical Thermometer-Continuous Measurement of Electronic Thermometer Performance Requirements”, YY 0785-2010
Medical Infrared Thermometer for Ear Cavity “Medical Infrared Thermometer-Part 1: Ear Cavity”, GB/T 21417.1-2008
High Frequency Surgical Equipment “Medical Electrical Equipment-Part 2-2: Special Requirements for Safety of High Frequency Surgical Equipment”, GB 9706.4-2009/IEC 60601-2-2:1998
High Frequency Surgical Equipment “Medical Electrical Equipment-Part 2-3: Special Requirements for Safety of High Frequency Surgical Equipment”, IEC 60601-2-2:2006
High Frequency Electrocautery Therapy Equipment “High Frequency Electrocautery Therapy Equipment”, YY 0322-2009
Cardiac Radiofrequency Ablation Therapy Equipment “Cardiac Radiofrequency Ablation Therapy Equipment”, YY 0860-2011
Liver Radiofrequency Ablation Therapy Equipment “Liver Radiofrequency Ablation Therapy Equipment”, YY 0776-2010
ENT Radiofrequency Ablation Equipment “ENT Radiofrequency Ablation Equipment”, YY 0897-2013
Radiofrequency Ablation Catheter “Radiofrequency Ablation Catheter”, YY 0778-2010
Gynecological Radiofrequency Rherapy Apparatus “Gynecological Radiofrequency Rherapy Apparatus”, YY 0650-2008
Medical Ultrasound Diagnostic and Monitoring Equipment “B-Type Ultrasonic Diagnostic Equipment”, GB 10152-2009
Medical Ultrasound Diagnostic and Monitoring Equipment “Medical Ultrasound Diagnostic Equipment Sound Output Announcement Requirements”, GB 16846-2008/IEC 61157:1992
Medical Ultrasound Diagnostic and Monitoring Equipment “Medical Electrical Equipment-Part 2-37: Special Requirements for Safety of Ultrasound Diagnostic and Monitoring Equipment”, GB 9706.9-2008
Medical Ultrasound Diagnostic and Monitoring Equipment “Medical Electrical Equipment-Part 2-37: Special Requirements for Safety of Ultrasound Medical Diagnostic and Monitoring Equipment”, IEC 60601-2-37:2004
Medical Ultrasound Diagnostic and Monitoring Equipment “Ultrasonic Field Characteristics of Acoustics in the Frequency Range of 0.5~15Mz and Its Measurement Hydrophone Method”, GB/T 16540-1996
Ultrasound Therapy Equipment “Medical Electrical Equipment-Part 2-5: Special Requirements for Safety of Ultrasound Therapy Equipment”, GB 9706.7-2008/IEC 60601-2-5:2000
Ultrasound Diagnostic and Monitoring “Medical Electrical Equipment-Part 2-37: Special Requirements for Safety and Basic Performance of Medical Ultrasound Diagnostic and Monitoring Equipment”, IEC 60601-2-37-2007
Ultrasound Doppler Fetal Heart Rate Monitor “Ultrasound Doppler Fetal Heart Rate Monitor”, YY 0448-2009
Ultrasound Doppler Fetal Monitor “Ultrasound Doppler Fetal Monitor”, YY 0449-2009
Doppler Perfusion Imager Ultrasound Transcranial Doppler Blood Flow Analyzer, YY/T 0593-2015
Ultrasound Diagnostic Equipment “Ultrasonic Sound Field Characteristics: Test Method for Determining Thermal Field and Mechanical Index of Medical Diagnostic Ultrasound Field, YY/T 0642-2014/IEC 62359:2010
Ultrasound Color Flow Imaging System “Ultrasound Color Blood Flow Imaging System”, YY 0767-2009
Ultrasound Bone Sonometers Ultrasound Bone Sonometers, YY 0774-2010
Medical Ultrasound Equipment Grade Series-Part 1: B-mode Ultrasound Diagnostic Equipment Medical Ultrasound Equipment Grade Series-Part 1: B-mode Ultrasound Diagnostic Equipment, YY/T 0162.1-2009
Ultrasound Diagnostic Equipment Measuring Method of Acoustic Output Power of Medical Ultrasonic Diagnostic Equipment, YY/T 1084-2015
Ultrasound Diagnostic Equipment B-type Yltrasound Diagnostic Equipment Verification Guide, YY/T 0938-2014
Ultrasound Diagnostic Equipment M Mode Test Method of Ultrasonic Diagnostic Equipment M Mode, YY/T 0108-2008
Ultrasonic Surgical System “Measurement and Publication of Basic Output Characteristics of Ultrasound Surgical Systems”, YY/T 0644-2008/IEC 61847:1998
Ultrasonic Real-time Pulse Echo System “Experimental Test Method for Ultrasonic Real-time Pulse Echo System”, YY/T 0703-2008/IEC 61390:1996
Ultrasound Pulse Echo Scanners-Part 1: Measurement Technical Method for Calibrating Spatial Measurement System-System Point Spread Function Response “Ultrasound Pulse Echo Scanners-Part 1: Measurement Technical Method for Calibrating Spatial Measurement System-System Point Spread Function Response”, YY/T 0748.1-2009/IEC 61391-1:2006
Performance Requirements and Measurement and Reporting Methods for Handheld Probe-type Doppler Fetal Heart Rate Monitors “Ultrasound Performance Requirements and Measurement and Reporting Methods for Handheld Probe-type Doppler Fetal Heart Rate Monitors”, YY/T 0749-2009/IEC 61266:1994
Ultrasound Diagnostic Equipment B-type Ultrasonic Diagnostic Equipment Performance Test Method with Intracavity Probe, YY/T 0906-2013
Ultrasound Diagnostic Equipment Measuring Method of Acoustic Output Power of Medical Ultrasonic Diagnostic Equipment, YY/T 1084-2015
Medical Ultrasound Equipment Guide to the Measurement and Characterization of Sound Field Characteristics of Medical Ultrasound Devices Using Hydrophones in the Frequency Range from 0.5 MHz to 15 MHz, YY/T 1088-2007/IEC 61220:1993
Cellular Pulse Echo Ultrasonic Transducer “Basic Electroacoustic Characteristics and Measurement Methods of Cellular Pulse Echo Ultrasonic Transducers”, YY/T 1089-2007
Ultrasound Equipment Method for Measuring the Beam Area of Transducers for Medical Ultrasound Equipment, YY/T 1278-2015
Ultrasound Equipment Three-dimensional Ultrasound Imaging Performance Test Method, YY/T 1279-2015
High Intensity Focused Ultrasound High Intensity Focused Ultrasound, YY 0592-2016
Ultrasonic Dental Cleaning Equipment Ultrasonic Dental Cleaning Equipment, YY 0460-2009
Superficial Tissue Ultrasound Treatment Equipment Superficial Tissue Ultrasound Treatment Equipment, YY 0830-2011
Medical Ultrasonic Nebulizer Medical Ultrasonic Nebulizer, YY 0109-2013
Ultrasound Therapy Equipment Ultrasound Therapy Equipment, YY 1090-2009
Requirements and Measurement Methods for Sound Field in the Frequency Range of 0.5MHZ~5MHZ Ultrasound Therapy Equipment • Requirements and Measurement Methods for Sound Field in the Frequency Range of 0.5MHZ~5MHZ, YY/T 0750-2009/IEC 61689:2007
Measurement and Publication of Ultrasonic Tooth Output Characteristics Measurement and Publication of Ultrasonic Tooth Output Characteristics, YY/T 0751-2009/EC61205:1993
Light Therapy Equipment for Baby “Medical Electrical Equipment-Part 2: Light Therapy Equipment for Baby”, YY 0669-2008/IEC 60601-2-50:2005
Baby Incubator “Medical Electrical Equipment-Part 2: Special Requirements for Safety of Baby Incubator”, GB 11243-2008
Radiating Baby Warmers “Medical Electrical Equipment-Part 2: Special Requirements for Safety of Radiating Baby Warmers”, YY 0455-2011/IEC 60601-2-21:1994+A1:1996
Transfer Incubator “Medical Electrical Equipment-Part 2: Special Requirements for Safety of Transfer Incubator”, YY 0827-2011
Electric Ventilator “Medical Electrical Equipment-Part 2: Special Requirements for Safety of Electric Ventilator”, GB 9706.28-2006
Electric Ventilator “Medical Electrical Equipment-Part 2: Special Requirements for Safety of Electric Ventilator”, IEC 60601-2-12:2001
Therapy Ventilator “Medical Electrical Equipment-Part 2-12: Specific Requirements for Basic Safety and Basic Performance of Therapeutic Ventilators”, ISO 80601-2-12:2011
Sleep Apnea Therapy Device “Medical Electrical Equipment-Part 2-70: Specific Requirements for Basic Safety and Basic Performance of Sleep Apnea Therapy Device”, ISO 80601-2-70:2015
Household Ventilator “Special Requirements for Basic Safety and Main Performance of Medical Ventilators-Part 1: Household Respiratory Support Equipment”, YY 0600.1-2007
Household Ventilator “Special Requirements for Basic Safety and Main Performance of Medical Ventilators-Part 1: Household Respiratory Support Equipment”, YY 0600.2-2007
Ventilator for First Aid and Transfer “Special Requirements for Basic Safety and Main Performance of Medical Ventilators-Part 3: Ventilator for First Aid and Transfer”, YY 0600.3-2007
Manual Resuscitator “Special Requirements for Basic Safety and Main Performance of Medical Ventilators-Part 4: Manual Resuscitator”, YY 0600.4-2013
Pneumatic First Aid Resuscitator “Special Requirements for Basic Safety and Main Performance of Medical Ventilators-Part 5: Pneumatic First Aid Resuscitator”, YY 0600.5-2011
High Frequency Jet Ventilator “High Frequency Jet Ventilator”, YY0042-2007
Sleep Apnea Therapy Part 1: Sleep Apnea Therapy Equipment “Sleep Apnea Therapy Part 1: Sleep Apnea Therapy Equipment”, YY 0671.1-2009
Mask “Sleep Apnea Therapy Part 2: Mask and Application Attachments”, YY 0671.2-2011
Medical Respiratory Humidifier Medical Respiratory Humidifier • Special Requirements for Respiratory Humidification Systems, YY 0786-2010
Anesthesia Machine (Workstation) “Medical Electrical Equipment-Part 2: Special Requirements for Safety and Basic Performance of An Anesthesia System”, GB 9706.29-2006
Anesthesia and Respiratory Equipment Anesthesia and Respiratory Equipment • Compatibility with Oxygen, YY/T 0882-2013
Anesthesia Workstation Medical Electrical Equipment-Part 2-13: Specific Requirements for Basic Safety and Performance in An Anesthesia Work Area, ISO 80601-2-13:2011
Anesthesia and Respiratory Equipment Anesthesia and Respiratory Equipment • Conical Joints-Part 1: Cone and Taper Sets, YY/T 1040.1-2015
Anesthetic Gas Monitor Medical Electrical Equipment • Basic Safety and Main Performance Specific Requirements for Respiratory Gas Monitors,YY 0601-2009
Adult Anesthesia Respiratory System Inhalation Anesthesia System-Part 1: Anesthesia Respiratory System, YY 0635.1-2013
Inhalation Anesthesia Systems-Part 2: Anesthetic Gas Purification Systems Delivery and Collection Systems Inhalation Anesthesia Systems-Part 2: Anesthetic Gas Purification Systems Delivery and Collection Systems, YY 0635.2-2009
Inhalation Anesthesia Systems-Part 3: Anesthetic Gas Delivery Device Inhalation Anesthesia Systems-Part 3: Anesthetic Gas Delivery Device, YY 0635.3-2009
Inhalation Anesthesia Systems-Part 4: Anesthesia Ventilator Inhalation Anesthesia Systems-Part 4: Anesthesia Ventilator,YY 0635.4-2009
Anesthesia Breathing Apparatus Humidification of Human Respiratory Gases Heat and Moisture Exchange (HME)-Part 1: Minimum Tidal Volume 250mL HME “Anesthesia Breathing Apparatus Humidification of Human Respiratory Gases Heat and Moisture Exchange (HME)-Part 1: Minimum Tidal Volume 250mL HME”, YY/T 0735.1-2009
Anesthesia and Respiratory Equipment “Heterinary and Respiratory Equipment for Humidification of Human Respiratory Gases (HMEs)-Part 2: HMEs for Tidal Volume Above 250 m1 for Patients Undergoing Tracheotomy”, YY/T 0735.2-2010
Anaesthetic and Respiratory Systems-Part 1 : Salt Test Method for Evaluation of Filtration Performance “Anaesthetic and Respiratory Systems-Part 1 : Salt Test Method for Evaluation of Filtration Performance”, YY/T 0753.1-2009
Anaesthetic and Respiratory Systems-Part 2 : Non-filtering Aspect Anaesthetic and Respiratory Systems-Part 2 : Non-filtering Aspect, YY/T 0753.2-2009
Special Requirements for Safety and Performance of Blood Pressure Transmission Pipelines for Invasive Blood Pressure Monitoring Equipment “Special Requirements for Safety and Performance of Blood Pressure Transmission Pipelines for Invasive Blood Pressure Monitoring Equipment”, YY/T 0754-2009
Anesthesia Evaporator • Anesthesia Special Filling System Anesthesia Evaporator • Anesthesia Special Filling System, YY 0755-2009
Freestanding Gas Mixer Medical Gas Mixer-Freestanding Gas Mixer, ISO 11195-1995
Safety Requirements for Medical Oxygen Concentrators “Safety Requirements for Medical Oxygen Concentrators”, YY 0732-2009
Medical Gas Mixer Medical Gas Mixer-Freestanding Gas Mixer, YY 0893-2013
Oxygen Equipment for Medical Molecular Sieves General Technical Specification for Oxygen Equipment for Medical Molecular Sieves, YY/T 0298-1998
Terminals for Medical Gas Pipeline Systems Terminals for Medical Gas Pipeline Systems-Part 1: Terminals for Compression of Medical Gases and Vacuums, YY 0801.1-2010
Terminals for Medical Gas Pipeline Systems Terminals for Medical Gas Pipeline Systems-Part 2: Terminal for Anesthetic Gas Purification System, YY 0801.2-2010
Medical Gas Pressure Regulators Medical Gas Pressure Regulators-Part 2: Busbar Pressure Regulators and Pipeline Pressure Regulators, YY/T 1439.2-2016
High-pressure Flexible Connection High-pressure Flexible Connection for Use with Medical Gas Systems, YY/T 1440-2016
Electric Suction Device Medical Suction Equipment-Part 1: Safety Requirements for Electric Suction Equipment, YY 0636.1-2008
Manually Driven Suction Device Medical Suction Equipment-Part 2: Manually Driven Suction Equipment, YY 0636.2-2008
Suction Equipment Powered by Negative Pressure or Pressure Source “Medical Suction Equipment-Part 3: Suction Equipment Powered by Negative Pressure or Pressure Source”, YY 0636.3-2008
Medical Center Attraction System General Technical Requirements for Medical Center Attraction System, YY/T 0186-94
Medical Center Oxygen Supply System General Technical Requirements for Medical Center Oxygen Supply System, YY/T0187-94
Buoy Type Oxygen Inhaler “Buoy Type Oxygen Inhaler”, YY 1107-2003
Medical Gas Low Pressure Hose Assembly Medical Gas Low Pressure Hose Assembly, YY/T 0799-2010
Medical Foot Switches General Technical Requirements for Medical Foot Switches, YY 1057-2016
Operating Tables(Including Electric) Medical Electrical Equipment-Part 2: Special Requirements for Safety of Operating Tables, YY 0570-2013
Operating Tables(Including Electric) Electric Operating Table, YY 1106-2008
Electric Traction Bed Electric Traction Bed, YY0697-2008
Hospital Electric Bed Safety Medical Electrical Equipment-Part 2: Special Requirements for Hospital Electric Bed Safety, YY 0571-2013
Ordinary Bed “Ordinary Bed”, YY 0045-2013
Electric Bone Tissue Surgery Equipment Electric Bone Tissue Surgery Equipment, YY/T 0752-2009
Battery-Powered Bone Tissue Surgery Equipment Battery-Powered Bone Tissue Surgery Equipment, YY 0904-2013
Conjoined Dental Treatment Equipment Dental Treatment Machine, YY/T 1043-2004
Conjoined Dental Treatment Equipment Dentistry Dental Lamp, YY/T 1120-2009
Conjoined Dental Treatment Equipment Dental Handpieces-Part 2: Straight and Contra-angle Handpieces, YY 1045.2-2010
Conjoined Dental Treatment Equipment Dental Handpieces-Part 1: High-speed Gas Turbines, YY 1045.1-2009
Conjoined Dental Treatment Equipment Dentistry Dental Therapy Machine-Part 2: Water Supply and Gas Supply, YY/T 0630-2008
Dental Treatment Machine Dental Treatment Machine, YY/T 1043-2004
Dental Chair Dental Research Patient Chair, YY/T 0058-2015
Dental Lamp Dentistry • Dental Lamp, YY/T 1120-2009/ISO 9680:2007
High Speed Turbo Drill Handpieces Dental Handpieces-Part 1: High-speed Gas Turbines, YY 1045.1-2009
High Speed Turbo Drill Handpieces Dental Handpieces-Part 1: High Speed Turbine Handpieces ISO 7785-1:1997
Straight and Contra-angle Handpieces Dental Handpieces-Part 2: Straight and Contra-angle Handpieces, YY 1045.2-2010
High Speed Turbine Drilling Machine “High Speed Turbine Drilling Machine”, YY 91044-1999
Electric Motor System Dental Handpiece • Dental Low Voltage Electric Motor, YY 0836-2011
Air Motor Cover Dental Handpiece • Dental Air Motor, YY 0837-2011
Dental Burs Dental Rotary Instruments • Burs-Part 1: Steel and Carbide Burs, YY 0302.1-2010
Dental Equipment-Connection to the Discharge Line “Dental Equipment-Connection to the Discharge Line”, YY/T 0725-2009
Dental Light Curing Machine Dental Light Curing Machine-Part 1: Quartz Tungsten Halogen Lamp, YY 0055.1-2009
Dental Light Curing Machine Dental Light Curing Machine-Part 2: Light Emitting Diode (LED) Light, YY 0055.2-2009
Positron Emission Tomography and X-ray Computed Tomography Systems “Performance and Test Methods for Positron Emission Tomography and X-ray Computed Tomography Systems”, YY/T 0829-2011
CT Equipment Medical Electrical Equipment-Part 2-44: Special Requirements for Basic Safety and Performance of X-ray Computed Tomography Equipment, IEC 60601-2-44:2012
X-ray Computed Tomography Equipment General Technical Requirements for X-ray Computed Tomography Equipment, YY 0310-2015
Oral X-ray Digital Tomography Equipment Special Technical Requirements for Oral X-ray Digital Tomography Equipment, YY/T 0795-2010
X-ray Computed Tomography Equipment Medical Electrical Equipment-Part 2: Special Requirements for Safety of X-ray Computed Tomography Equipment, GB 9706.18-2006
Digital X-ray Imaging Devices “Characteristics of Digital X-ray Imaging Devices-Part 1: Determination of Quantum Detection Efficiency”, YY/T 0590.1-2005
Digital X-ray Imaging Devices “Characteristics of Digital X-ray Imaging Devices-Part 1-2: Determination of Quantum Detection Efficiency • Mammography X-ray Photography Detector, YY/T 0590.2-2010
Medical Diagnostic X-Ray Machine “General Technical Requirements for Medical Diagnostic X-Ray Machine”, YY/T 0106-2008
Medical Diagnostic X-Ray Machine Medical Electrical Equipment-Part 2: Special requirements for Safety of High-voltage Generators for Diagnostic X-ray Generators, GB 9706.3-2000/IEC 60601-2-7:1998
Medical Diagnostic X-Ray Machine “Medical Electrical Equipment-Part 2: Special requirements for Safety of Medical Diagnostic X-ray Source Components and X-ray Tube Assemblies”, GB 9706.11-1997/IEC 601-2-28:1993
Medical Diagnostic X-Ray Machine “Medical Electrical Equipment-Part 1: General Requirements for Safety & Deneral Requirements for Radiation Protection of X-ray Equipments, GB 9706.12-1997/IEC 601-1-3:1994
Medical Diagnostic X-Ray Machine “Medical Electrical Equipment-Part 2: Special requirements for Safety of X-ray Equipment Auxiliary Equipment, GB 9706.14-1997/IEC 601-2-32:1994
Medical Diagnostic X-Ray Machine Environmental Requirements and Test Methods for Medical X-ray Equipment, YY/T 0291-2007
Medical Diagnostic X-Ray Machine “Medical Electrical Equipment-Part 2-43: Special requirements for Safety of X-ray Equipment for Interventional Procedures, GB 9706.23-2005/IEC 60601-2-43:2000
Medical Diagnostic X-Ray Machine “Medical Electrical Equipment-Part 2-45: Special requirements for Safety of Mammography Equipment and Mammography Stereo Positioning Devices, GB 9706.24-2005/IEC 60601-2-45:2001
Medical Diagnostic X-Ray Machine Special Technical Requirements for Oral X-ray Machines, YY/T 0010-2008
Medical Diagnostic X-Ray Machine Evaluation and Routine Testing of the Medical Imaging Sector-Part 3-1: X-ray Imaging Performance Acceptance Test for X-ray Imaging and Fluoroscopy Systems, GB/T 19042.1-2003
Medical Diagnostic X-Ray Machine Evaluation and Routine Testing of the Medical Imaging Sector-Part 3-1: X-ray Imaging Performance Acceptance Test for X-ray Imaging and Fluoroscopy Systems, GB/T 19042.2-2005
Medical Diagnostic X-Ray Machine Evaluation and Routine Testing of the Medical Imaging Sector-Part 3-3: Acceptance Test for Imaging Performance of Digital Subtraction Angiography X-ray Equipment, GB/T 19042.3-2005
Medical Diagnostic X-Ray Machine Evaluation and Routine Testing of the Medical Imaging Sector-Part 3-4: Acceptance Test for Imaging Performance of Dental X-ray Equipment, GB/T 19042.4-2005
Medical Diagnostic X-Ray Machine Special Technical Requirements for Micro Medical Diagnostic X-ray Machines, YY/T 0347-2009
X-Ray Diagnostic Machine Medical Electrical Equipment-Part 1-3: General Requirements for Basic Safety and Performance-Parallel Standard: Diagnosing Radiation Protection for X-ray Equipment, IEC 60601-1-3:2008
X-Ray Diagnostic Machine Medical Electrical Equipment-Part 2-28: Special Requirements for Basic Safety and Performance of Medical X-ray Tube Assemblies, IEC 60601-2-28:2010 IEC 60601-2-28:2010
X-Ray Diagnostic Machine Medical Electrical Equipment-Part 2-54: Special Requirements for Basic Safety and Performance of Photographic X-ray Equipment, IEC 60601-2-54:2009 IEC 60601-254:2009
X-Ray Diagnostic Machine Medical Electrical Equipment-Part 2-43: Special Requirements for Basic Safety and Performance of Interventional Operation X-Ray Equipment, IEC 60601-2-43:2010
X-ray Treatment Machine Medical Electrical Equipment-Part 2: Special Requirements for Safety of the Treatment of X-ray Generating Devices, GB 9706.10-1997/IEC 601-2-8:1987
X-ray Treatment Machine Medical Electrical Equipment-Part 3: Special Requirements for Safety of the Treatment of X-ray Generating Devices, YY/T 0317-2007
Mammography X-ray Machine Special Technical Requirements for Mammography X-ray Machine, YY/T 0706-2008
Mobile Photography X-ray Machines Special Technical Requirements for Mobile Photography X-ray Machines, YY/T 0707-2008
Dual Energy X-ray Bone Density Meter Special Technical Requirements for Dual Energy X-ray Bone Density Meter, YY/T 0724-2009
Medical Diagnostic X-ray Tube Assemblies General Technical Requirements for Medical Diagnostic X-ray Tube Assemblies, YY/T 06092007
Medical General Photography Digital X-ray Image Detector Medical General Photography Digital X-ray Image Detector, YY/T 0933-2014
Medical Diagnostic X-ray Image Intensifier Medical Diagnostic X-ray Image Intensifier, YY/T 0093-2013
Medical X-ray Image Intensifier TV System General Technical Requirements for Medical X-ray Image Intensifier TV System, YY/T 0608-2013
Medical Diagnostic X-ray Fluoroscopy Screen Medical Diagnostic X-ray Fluoroscopy Screen, YY/T 0094-2013
Medical Imaging Photo Observation Devices General Technical Requirements for Medical Imaging Photo Observation Devices, YY/T 0610-2007
Medical Diagnostic X-Ray Tube Medical Diagnostic X-Ray Tube XD1-3/100 Fixed Anode X-Ray Tube, YY/T 0197.1-2007
Medical Diagnostic X-Ray Tube Medical Diagnostic X-Ray Tube XD2-1/85 Fixed Anode X-ray Tube, YY/T 0197.2-2007
Medical Diagnostic X-Ray Tube Medical Diagnostic X-Ray Tube XD3-3.5/100 Fixed Anode X-ray Tube, YY/T 0197.3-2007
Medical Diagnostic X-Ray Tube Medical Diagnostic X-Ray Tube XD42, 9/100 Fixed Anode X-ray Tube, YY/T 0197.4-2007
Medical Diagnostic X-Ray Tube Medical Diagnostic X-Ray Tube XIID51-20, 40/100 and XD51-20, 40/125 Rotating Anode X-ray Tube, YY/T 0197.5-2007
X-ray Film Cassette X-ray Film Cassette, YY 0011-2007
Medical Diagnostic X-Ray Variable Beam Limiters General Technical Requirements for Medical Diagnostic X-Ray Variable Beam Limiters, YY/T 0129-2007
Packaging, Transportation and Storage of Medical X-ray Equipment Packaging, Transportation and Storage of Medical X-ray Equipment, YY/T 1099-2007
Special Technical Requirements for Medical X-ray Photography Beds Special Technical Requirements for Medical X-ray Photography Beds, YY/T 0737-2009
Special Technical Requirements for Medical X-ray Catheter Bed Special Technical Requirements for Medical X-ray Catheter Bed, YY/T 0738-2009
Special Technical Requirements for Medical X-ray Vertical Photography Frame Special Technical Requirements for Medical X-ray Vertical Photography Frame, YY/T 0739-2009
Special Technical Requirements for Medical Angiography X-ray machine Special Technical Requirements for Medical Angiography X-ray machine, YY/T 0740-2009
Special Technical Requirements for Digital Medical X-ray System “Special Technical Requirements for Digital Medical X-ray System”, YY/T 0741-2009
Special Technical Requirements for Gastrointestinal X-ray Machine Special Technical Requirements for Gastrointestinal X-ray Machine, YY/T 0742-2009
Special Technical Requirements for X-ray Gastrointestinal Diagnostic Bed Special Technical Requirements for X-ray Gastrointestinal Diagnostic Bed, YY/T 0743-2009
Special Technical Requirements for Mobile C-arm X-ray Machine Special Technical Requirements for Mobile C-arm X-ray Machine, YY/T 0744-2009
Special Technical Requirements for Remote-controlled Perspective X-ray Machine Special Technical Requirements for Remote-controlled Perspective X-ray Machine, YY/T 0745-2009
Special Technical Requirements for Vehicle X-Ray Machines Special Technical Requirements for Vehicle X-Ray Machines, YY/T 0746-2009
Medical X-ray Television Equipment Performance Parameters and Measurement Methods of Medical X-ray Image Intensifier TV System, SJ/T 11094-1996
Calcium Tungstate Medium Speed Medical Intensifying Screen “Calcium Tungstate Medium Speed Medical Intensifying Screen”, YY/T 0095-2013
Thermal Printers General Specification for Thermal Printers, GB/T 28165-2011
Electronic Accelerators Special Requirements for Safety of Electronic Accelerators, GB 9706.5-2008/IEC 60601-2-1: 1998
Radionuclide Imaging Equipment Radionuclide Imaging Equipment Performance and Test Rules-Part 1: Positron Emission Tomography Apparatus, GB/T 18988.1-2013
Radionuclide Imaging Equipment Radionuclide Imaging Equipment Performance and Test Rules-Part 2: Single Photon Emission Computed Tomography Device, GB/T 18988.2-2003
Radiotherapy Planning System Special Requirements for Safety of Medical Electrical Equipment Radiotherapy Planning System, YY 0637-2013
Magnetic Resonance Equipment Medical Electrical Equipment-Part 2-33: Special Requirements for Basic Safety and Performance of Medical Diagnostic Magnetic Resonance Equipment, IEC 60601-2-33:2010
Determination of Main Image Quality Parameters of Medical Imaging Magnetic Resonance Equipment “Determination of Main Image Quality Parameters of Medical Imaging Magnetic Resonance Equipment”, YY/T 0482-2010
Determination of Main Image Quality Parameters of Medical Imaging Magnetic Resonance Equipment Medical Electrical Equipment-Part 2: Special Requirements for Safety of Magnetic Resonance Equipment for Medical Diagnostics, YY 0319-2008
Endoscope Medical Endoscope • Endoscope Attachment Mirror Sheath, YY/T 0842-2011
Endoscope Medical Electrical Equipment-Part 2: Special Requirements for Safety of Endoscopes, GB 9706.19-2000/IEC 60601-2-18:1996
Fiber Upper Digestive Tract Endoscope Fiber Upper Digestive Tract Endoscope, YY 1028-2008
Hard Endoscopes Medical Endoscopes • Hard Endoscopes-Part 1: Optical Performance and Test Methods, YY 0068.1-2008
Hard Endoscopes Medical Endoscopes • Hard Endoscopes-Part 2: Mechanical Properties and Test Methods, YY 0068.2-2008
Hard Endoscopes Medical Endoscopes • Hard Endoscopes-Part 3: Labels and Accompanying Materials, YY 0068.3-20080
Hard Endoscopes Medical Endoscopes • Hard Endoscopes-Part 4: Basic requirements, YY 0068.4-2009
Hard hysteroscope Hard hysteroscope, YY 1075-2007
Hard Arthroscopy Hard Arthroscopy, YY 1082-2007
Medical Fiber Endoscope Fiber Guided Cystoscope, YY 91083-1999
Medical Fiber Endoscope General Requirements for Medical Endoscopes and Attachment, GB 11244-2005
Medical Fiber Endoscope Fiber Coatoscopy, YY/T 0283-2007
Medical Fiber Endoscope Medical Electrical Equipment-Part 2: Special Requirements for Safety of Endoscopes, GB 9706.19-2000/IEC 60601-2-18:1996
Esophagoscope “Esophagoscope”, YY 0070-2008
Rectal, Sigmoid Colonoscopy Rectal, Sigmoid Colonoscopy, YY 0071-2008
Medical Endoscope Cold Light Source Medical Endoscope Cold Light Source, YY 1081-2011
Optical Cable for Medical Endoscope Lighting “Optical Cable for Medical Endoscope Lighting”, YY 0763-2009
Rolling Flushing Aspirator Medical Endoscope•Endoscope Function Supply Device-Rolling Flushing Aspirator, YY/T 0863-2011
Liquid Expansion Pump Medical Endoscope•Endoscope Function Supply Device-Liquid Expansion Pump, YY/T 0864-2011
Insuffiater Medical Endoscope•Endoscope Function Supply Device-Insuffiater, YY 0843-2011
Photobiosafety of Lamps and Lamp Systems Photobiosafety of Lamps and Lamp Systems, GB/T 20145-2006
Lamps and Lamp Systems Photobiosafety of Lamps and Lamp Systems, IEC 62471-2006
Diagnostic and Therapeutic Laser Equipment Medical Electrical Equipment-Part 2: Special Requirements for Safety of Diagnostic and Therapeutic Laser Equipment, GB 9706.20-2000/IEC 60601-2-22:1995
Safety of Laser Products “Safety of Laser Products-Part 1: Equipment Classification, Requirements”, GB 7247.1-2012/IEC 60825-1:2007
Carbon Dioxide Laser Treatment Machine Carbon Dioxide Laser Treatment Machine, GB 11748-2005
Pulsed Carbon Dioxide Laser Therapy Machine Laser Treatment Equipment • Pulsed Carbon Dioxide Laser Therapy Machine, YY 0844-2011
Yttrium Aluminum Garnet Laser Treatment Machine Laser Treatment Equipment • Yttrium Aluminum Garnet Laser Treatment Machine, YY 0846-2011
Laser Protective Glasses Laser Protective Glasses, GB/T 17736-1999
Yttrium Aluminum Garnet Laser Treatment Machine with Continuous Wave Yttrium Aluminum Garnet Laser Treatment Machine with Continuous Wave,  YY 0307-2011
Semiconductor Laser Photodynamic Therapy Machine Laser Treatment Equipment • Semiconductor Laser Photodynamic Therapy Machine, YY 0845-2011
Laser Fiber for Treatment General Requirements for Laser Fiber for Treatment, YY/T 0758-2009
Dental Light Curing Machine-Quartz Tungsten Halogen Lamp Dental Light Curing Machine-Part 1: Quartz Tungsten Halogen Lamp, YY 0055.1-2009
Dental Light Curing Machine-Light Emitting Diode (LED) Light Dental Light Curing Machine-Part 2: Light Emitting Diode (LED) Light, YY 0055.2-2009
Contact Lens Care Solution “Hygiene Requirements for Contact Lens Care Solution”, GB 19192-2003
Contact Lenses and Contact Lens Care Products “Opticianry • Guide for the Determination of the Uptake and Release of Preservatives for Contact Lenses and Contact Lens Care Products, GB/T 28539-2012
Opticianry •  Contact Lens Care Products “Opticianry • Contact Lens Care Products-Part 2: Basic Requirements, YY 0719.2-2009
Opticianry • Contact Lenses and Contact Lens Care Products Physical Compatibility “Opticianry • Contact Lens Care Products-Part 5: Physical Measurement of Contact Lens and Contact Lens Care Products, YY 0719.5-2009
Opticianry •  Contact Lens Care Products “Opticianry • Contact Lens Care Products-Part 6: Guide to the Determination of the Effective Period, YY 0719.6-2010
Opticianry •  Contact Lens Care “Opticianry • Contact Lens-Part 1: Specification for Vocabulary, Classification and Recommendations, GB/T 11417.1-2012
Opticianry •  Contact Lens Care “Opticianry • Contact Lens-Part 3: Soft Contact Lenses, GB 11417.3-2012
Semiconductor Laser Photodynamic Therapy Machine Laser Treatment Equipment • Semiconductor Laser Photodynamic Therapy Machine, YY 0845-2011
Opticianry •  Contact Lens “Opticianry • Contact Lens-Part 4: Standard Salt Solutions for Testing”, GB/T 11417.4-2012
Opticianry •  Contact Lens “Opticianry • Contact Lens-Part 5: Test Methods for Optical Performance”, GB/T 11417.5-2012
Opticianry •  Contact Lens “Opticianry • Contact Lens-Part 6: Test Methods for Mechanical Properties”, GB/T 11417.6-2012
Opticianry •  Contact Lens “Opticianry • Contact Lens-Part 7: Test Methods for Physical and Chemical Performance”, GB 11417.7-2012
Ophthalmic Equipments Ophthalmic Equipments – Basic Requirements and Test Method-Part 1: General Requirements for Ophthalmic Devices, ISO 15004-1:2006
Ophthalmic Surgical Instruments Ophthalmic Surgical Instruments – Basic Requirements and Test Method-Part 2: Photohazard Protection, ISO 15004-2:2007
Ophthalmic High-frequency Ultrasound System Ophthalmic High-frequency Ultrasound System, YY 0849-2011
Ophthalmic Instruments – Eye Chart Projector Ophthalmic Instruments – Eye Chart Projector, YY 0764-2009
Ophthalmic Instruments – Intraocular Illuminators Ophthalmic Instruments – Intraocular Illuminators-Part 2: Basic Requirements and Test Methods for Optical Radiation Safety, YY 0792.2-2010
Ophthalmic Instruments – Optometer Ophthalmic Instruments – Optometer, YY 0673-2008
Optometry Ophthalmic Instruments – Optometry, YY 0673-2008
Indirect Ophthalmoscope Ophthalmic Instruments – Indirect Ophthalmoscope, YY 0633-2008
Direct Ophthalmoscope Ophthalmic Instruments – Direct Ophthalmoscope, YY 1080-2009
Keratometry Ophthalmic Instruments – Keratometry, YY 0579-2005
Standard Logarithmic Visual Acuity Chart Standard Logarithmic Visual Acuity Chart, GB 11533-2011
Lighting of Surgery and Diagnosis Medical Electrical Equipment-Part 2: Special Requirements for Safety of Surgical Shadowless Lamps and Diagnostic Lightings, YY 0627-2008
Microscope Biological Microscope, GB/T 2985-2008
Slit Lamp Microscope Ophthalmic Instruments – Slit Lamp Microscope, YY 0065-2007
Microcirculation Microscope Microcirculation Microscope, YY 0067-2007
Biological Microscope Biological Microscope, GB/T 2985-2008
Surgical Microscopes “Surgical Microscopes-Part 1: Requirements and Test Methods”, GB 11239.1-2005
Medical Forehead Lighting Medical Lighting Source-Medical Forehead Lighting, YY/T 0932-2014
Infusion Pumps and Infusion Controllers Medical Electrical Equipment-Part 2-24: Special Requirements for Safety of Infusion Pumps and Infusion Controllers, GB 9706.27-2005/IEC 60601-2-24:1998
High Pressure Injection Device Special Technical Requirements for Angiographic High Pressure Injection Device, YY/T 0891-2013
CT Contrast Injection Equipments Special Technical Requirements for CT Contrast Injection Equipments, YY/T 0935-2014
Electric Gastric Lavatory Machine Electric Gastric Lavatory Machine, YY 1105-2008
Medical Air Pressurized Oxygen Chamber Medical Air Pressurized Oxygen Chamber, GB/T 12130-2005
Medical Oxygen Pressure Chamber Medical Oxygen Pressure Chamber, GB/T 19284-2003
Hearing Aid (Including Box) “Performance Measurement of Quality Inspection of Hearing Aids on Delivery”, SJ/T 10862-96
Hearing Aid (Including Box) Electroacoustics • Hearing Aids-Part 0: Measurement of Electroacoustic Characteristics, GB/T 25102.100-2010
Hearing Aid (Including Box) Electroacoustics • Hearing Aids-Part 1: Hearing aids with Inductive Pickup Coil Input, GB/T 25102.1-2010
Hearing Aid (Including Box) Electroacoustics • Hearing Aids-General Specification, GB/T 14199-2010
Hearing Aid (Including Box) Electroacoustics • Hearing Aids-Part 2: Hearing Aids with Automatic Gain Control Circuits, GB/T 25102.2-2010
Software Products Software Engineering – Software Product Quality Requirements and Evaluation (SQuaRe) SQuaRe Guide, GB/T 25000.51-2010 5.1
Software Engineering – Software Product Quality Requirements and Evaluation (SQuaRe) SQuaRe Guide, GB/T 25000.51-2010 5.2
Software Engineering – Software Product Quality Requirements and Evaluation (SQuaRe) SQuaRe Guide, GB/T 25000.51-2010 5.3.1
Software Engineering – Software Product Quality Requirements and Evaluation (SQuaRe) SQuaRe Guide, GB/T 25000.51-2010 5.3.2
Software Engineering – Software Product Quality Requirements and Evaluation (SQuaRe) SQuaRe Guide, GB/T 25000.51-2010 5.3.5
Wheelchair Electric Wheelchairs, GB/T 12996-2012
Wheelchair Manual Wheelchairs, GB/T 13800-2009
Electric Wheelchairs Electric Wheelchairs, GB/T 12996-2012
Wheelchairs-Part 4: Determination of Theoretical Energy Consumption of Electric Wheelchairs and Electric Scooters Wheelchairs-Part 4: Determination of Theoretical Energy Consumption of Electric Wheelchairs and Electric Scooters, GB/T 18029.4-2009
Wheelchairs-Part 7: Measurement of Seat and Wheel Dimensions Wheelchairs-Part 7: Measurement of Seat and Wheel Dimensions, GB/T 18029.7-2009
Joint Passive Exercise Equipment Elbow and Knee Passive Exercise Equipment, YY/T 0997-2015
Hemodialysis, Hemodiafiltration and Hemofiltration Equipment Medical Electrical Equipment-Part 2-16: Special Requirements for Safety of Hemodialysis, Hemodiafiltration and Hemofiltration Equipment, GB 9706.2-2003/IEC 60601-2-16:1998
Peritoneal Dialysis Equipment Medical Electrical Equipment-Part 2-39: Special Requirements for Safety of Peritoneal Dialysis Equipment, GB 9706.39-2008/IEC 60601-2-39:2003
Continuous Blood Purification Equipment Continuous Blood Purification Equipment, YY 0645-2008
Hemodialysis Equipment Hemodialysis Equipment, YY 0054-2010
Artificial Heart-lung Machine • Rolling Blood Pump Artificial Heart-lung Machine • Rolling Blood Pump, GB 12260-2005
Artificial Heart-lung Machine • Heat Exchange Water Tank Artificial Heart-lung Machine • Heat Exchange Water Tank, GB 12263-2005
Electrical Equipment for Measurement, Control and Laboratory Use Safety Requirements for Electrical Equipment for Measurement, Control and Laboratory-Part 3: Particular Requirements for Mixing and Mixing Equipment for Laboratory Use, GB 4793.3-2008/IEC 61010-2-051:2005
Heating Equipment for Laboratory Materials Safety Requirements for Electrical Equipment for Measurement, Control and Laboratory-Part 6: Particular Requirements for Heating Equipment for Laboratory Materials, GB 4793.6-2008/IEC 61010-2-010:2005
Automatic and Semi-automatic Equipment for Laboratory Analysis and Other Purposes Safety Requirements for Electrical Equipment for Measurement, Control and Laboratory-Part 9: Particular Requirements for Automatic and Semi-automatic Equipment for Laboratory Analysis and Other Purposes, GB 4793.9-2013/IEC 61010-2-081:2009
In Vitro Diagnostic (IVD) Medical Devices Safety Requirements for Electrical Equipment for Measurement, Control and Laboratory-Part 2-101: Particular Requirements for In Vitro Diagnostic (IVD) Medical Devices, YY 0648-2008/IEC 61010-2-101:2002
Automatic Biochemical Analyzer “Automatic Biochemical Analyzer”, YY/T 0654-2008
Biochemical Analyzer “Semi-automatic Biochemical aAnalyzer”, YY/T 0014-2005
Dry Chemistry Analyzer Dry Chemistry Analyzer, YY/T 0655-2008
Electrolyte Analyzer Electrolyte Analyzer, YY/T 0589-2005
Semi-automatic Chemiluminescence Immunoassay Analyzer Semi-automatic Chemiluminescence Immunoassay Analyzer, YY/T 1174-2010
Full-automatic Luminous Immunoassay Analyzer “Full-automatic Luminous Immunoassay Analyzer”, YY/T 1155-2009
Immunoassay Analyzer Time-resolved Fluorescence Immunoassay Systems-Part 1: Semi-automatic Time-resolved Fluorescence Immunoassay Analyzer, YY/T 1304.1-2015
Polymerase Chain Reaction Analyzer Polymerase Chain Reaction Analyzer, YY/T 1173-2010
Erythrocyte Sedimentation Rate Tester Erythrocyte Sedimentation Rate Tester, YY/T 1251-2014
Hemoglobin Meter Hemoglobin Meter, YY/T 0032-2004
Glycated Hemoglobin Analyzer Glycated Hemoglobin Analyzer, YY/T 1246-2014
Blood Glucose Testing System “General Technical Requirements for Self-test Blood Glucose Testing System for In Vitro Diagnostic Test System, GB/T 19634-2005
Blood Analyzer Blood Analyzer, YY/T 0653-2008
Automatic Coagulation Analyzer “Automatic Coagulation Analyzer”, YY/ T0659-2008
Semi-automatic Coagulation Analyzer “Semi-automatic Coagulation Analyzer” YY/T 0658-2008
Urine Visible Component Analyzer Urine Visible Component Analyzer (Digital Imaging Automatic Identification), YY/T 0996-2015
Dry Chemistry Urine Analyzer Dry Chemistry Urine Analyzer, YY/T 0475-2011
Low Temperature Sterilization Devices for Hydrogen Peroxide Gas Plasmas General Requirements for Low Temperature Sterilization Devices for Hydrogen Peroxide Gas Plasmas, GB 27955-2011
Drug Freezer Drug Freezer, YY/T 0086-2007
Blood Freezer Blood Freezer, YY/T 0168-2007
Dry Heat Sterilizers “Safety Use of Electrical Equipment for Measurement, Control and Laboratory – Special Requirements for Dry Heat Sterilizers for Treatment of Medical Materials and Laboratory Using Hot Air or Hot Inert Gas”, YY 0602-2007
Clean Workbench Clean Workbench, JG/T 292-2010
Micro Oscillators “Micro Oscillators” YY 0156-94
Biological Safety Cabinet “Class II Biological Safety Cabinet” YY 0569-2011
Autoclaves for the Treatment of Medical Materials in the Laboratory “Safety of Electrical Equipment for Measurement, Control and Laboratory – Special Requirements for Autoclaves for the Treatment of Medical Materials in the Laboratory”, GB 4793.4-2001/IEC 61010-2-41:1995
the Use of Toxic Gases for the Treatment of Medical Materials and Pressure Sterilizers and Sterilizers for Laboratory Use Safety Requirements for Electrical Equipment for Measurement, Control and Laboratory-Part 2-042: Particular Requirements for the Use of Toxic Gases for the Treatment of Medical Materials and Pressure Sterilizers and Sterilizers for Laboratory Use, GB 4793.8-2008
Large Steam Sterilizer Technology “Automatic Control Type for Large Steam Sterilizer Technology”, GB 8599-2008
Large Steam Sterilization Manual Control Type Large Steam Sterilization Manual Control Type, YY 0731-2009
Small Steam Sterilizer Automatic Control Type Small Steam Sterilizer Automatic Control Type, YY 0646-2015
Vertical Steam Sterilizer Vertical Steam Sterilizer, YY 1007-2010
Pulsating Vacuum Pressure Steam Sterilizer Pulsating Vacuum Pressure Steam Sterilizer, YY 0085.1-1992
Pre-vacuum Pressure Steam Sterilizer Pre-vacuum Pressure Steam Sterilizer, YY 0085.2-1992
Portable Pressure Steam Sterilizer Portable Pressure Steam Sterilizer, YY 0504-2005
Circular Pressure Steam Sterilizer “Strength Calculation of Main Pressure Components of Circular Pressure Steam Sterilizer and Related Regulations”, YY/T 0084.1-2009
Rectangular Pressure Steam Sterilizer “Strength Calculation of Main Pressure Components of Rectangular Pressure Steam Sterilizer and Related Regulations” ,YY/T 0084.2-2009
Medical Steam Generator Medical Steam Generator, YY 0791-2010
Electrothermal Distilled Water “Electrothermal Distilled Water”, YY/T 0280-1995
Spring Type Venting Valve Spring Type Venting Valve for Pressure Steam Equipment, YY/T 0157-2013
Steam Penetration Process Challenge Device and Indicator System for Steam Penetration Test, YY/T 0883-2013
Ethylene Oxide Sterilizer Ethylene Oxide Sterilizer, YY 0503-2005
Ethylene Oxide Sterilizer Physical and Microbiological Performance Requirements for Ethylene Oxide Sterilization-Part 2: Microbiological Requirements, YY/T 1302.2-201
Ozone Disinfection Cabinet “Ozone Disinfection Cabinet Safety, Disinfection Effect, General Technical Requirements”, YY 0215-2008
Cleaning Sterilizer Cleaning Sterilizer, YY/T 0734.1-2009
Cleaning Sterilizer “Cleaning Sterilizer”, YY/T 0734.2-2009
Cleaning Sterilizer “Cleaning Sterilizer”, YY/T 0734.3-2009
Electrical Thermostat Incubator “Electrical Thermostat Incubator”, YY 0027-90
Electric Heating Water Bath “Electric Heating Water Bath”, YY 91037-1999
Constant Water Tank “Constant Water Tank”, YY 91038-1999
Special Requirements for Laboratory Centrifuges “Safety Requirements of Electrical Equipment for Measurement, Control and Laboratory Use-Part 7: Special Requirements for Laboratory Centrifuges, GB 4793.7-2008
Medical Centrifuge Medical Centrifuge, YY/T 0657-2008
Blood Cell Analyzer Calibrator Blood Cell Analyzer Calibrator, YY/T 0701-2008
Blood Cell Analyzer Quality Control Blood Cell Analyzer Quality Control, YY/T 0702-2008
Reagents for Blood Analyzers-Part 1: Cleaning Fluids Reagents for Blood Analyzers-Part 1: Cleaning Fluids, YY/T 0456.1-2014
Reagents for Blood Analyzers-Part 2: Hemolysing Agents Reagents for Blood Analyzers-Part 2: Hemolysing Agents, YY/T 0456.2-2014
Reagents for Blood Analyzers-Part 3: Diluents Reagents for Blood Analyzers-Part 3: Diluents, YY/T 0456.3-2014
Thrombin Time Detection Reagent “Thrombin Time Detection Reagent (Box)”, YY/T 1156-2009
Activated Partial Thromboplastin Time Detection Reagent “Activated Partial Thromboplastin Time Detection Reagent(Box)”, YY/T 1157-2009
Prothrombin Time Detection Reagent “Prothrombin Time Detection Reagent (Box)”, YY/T 1158-2009
Fibrinogen Detection Reagent “Fibrinogen Detection Reagent (Box)”, YY/T 1159-2009
Human Chorionic Gonadotropin (HCG) Test Strip Human Chorionic Gonadotropin (HCG) Test Strip (Colloidal Gold Immunochromatography), YY/T 1164-2009
Luteinizing Hormone Test Strip “Luteinizing Hormone Test Strip (Colloidal Gold Immunochromatography)”, GB/T 18990-2008
Clinical Chemistry In Vitro Diagnostic Reagents (Box) Clinical Chemistry In Vitro Diagnostic Reagents (Box), GB/T 26124-2011
Alanine Aminotransferase Assay Kit Alanine Aminotransferase (ALT) Assay Kit (IFCC method), YY/T 1197-2013
Aspartate Aminotransferase Assay Kit “Aspartate Aminotransferase Assay Kit (IFCC method)”, YY/T 1198 2013
Glucose Assay Kit Glucose Assay Kit (Enzymatic Method), YY/T 1200-2013
Urea Determination Kit Urea Determination Kit (Enzyme Coupling Monitoring Method), YY/T 1201-2013
Potassium Assay Kit Potassium Assay Kit (Enzymatic Method), YY/T 1202-2013
Sodium Determination Kit Sodium Determination Kit (Enzymatic Method), YY/T 1203-2013
Chlorine Determination Kit Chlorine Determination Kit (Enzymatic Method), YY/T 1196-2013
Carcinoembryonic Antigen (CEA) Quantitative Assay Reagent (Box) Carcinoembryonic Antigen (CEA) Quantitative Assay Reagent (Box) (ChemiluminescenceImmunoassay), YY/T 1160-2009
AFP Quantitative Assay Reagent (Box) AFP Quantitative Assay Reagent (Box) (Chemiluminescence Immunoassay), YY/T 1162-2009
Tumor Marker Quantitative Assay Reagent (Box) Tumor Marker Quantitative Assay Reagent (Box) Chemiluminescence Immunoassay YY/T 1175-2010
Cancer Antigen CA5-3 Quantitative Assay Reagent (Box) Cancer Antigen CA5-3 Quantitative Assay Reagent (Box) Chemiluminescence Immunoassay, YY/T 1176-2010
Enzyme Chain Immunosorbent Assay Reagent (Box) Enzyme Chain Immunosorbent Assay Reagent (Box), YY/T 1183-2010
Lactate Dehydrogenase Assay Reagent (Box) Lactate Dehydrogenase Assay Reagent (Box), YY/T 1241-2014
A-hydroxybutyrate Dehydrogenase Assay Reagent (Box) A-hydroxybutyrate Dehydrogenase Assay Reagent (Box), YY/T 1242-2014
Creatine Kinase Assay Reagent (Box) Creatine Kinase Assay Reagent (Box), YY/T 1243-2014
Chemiluminescence Tumor Marker Quantitative Assay Reagent (Box) “Tumor-associated Antigen CA125 Quantitative Assay Kit (Chemiluminescence Method)”, YY/T 1161-2009
Chemiluminescence Tumor Marker Quantitative Assay Reagent (Box) Tumor-associated Antigen 199 (CA9-9) Quantitative Assay Kit (Chemiluminescence Method), YY/T 1178-2010
Chemiluminescence Tumor Marker Quantitative Assay Reagent (Box) Tumor-associated Antigen 50 (CA50) Quantitative Assay Kit (Chemiluminescence Method), YY/T 1179-2010
Urine Analysis Quality Control Urine Analysis Quality Control, YY/T 0501-2014
Dry Chemical Urine Test Strips General Technical Requirements for Dry Chemical Urine Test Strips, YY/T 0478-2011
Catalytic Antigen CA72-4 Quantitative Determination Reagent (Box) “Catalytic Antigen CA72-4 Quantitative Determination Reagent (Box) Chemiluminescence Immunoassay”, YY/T 1177-2010
Reagents for Nucleic Acid Amplification Detection (Box) “Reagents for Nucleic Acid Amplification Detection (Box)”, YY/T 1182-2010
A-Amylase Assay Reagent (Box) “A-Amylase Assay Reagent (Box) (Continuous Monitoring Method)”, YY/T 1194-2011
Triglyceride Assay Kit Triglyceride Assay Kit (Enzymatic Method), YY/T 1199-2013
Total Bile Acid Determination Kit “Total Bile Acid Determination Kit (Enzyme Cycle Method)”, YY/T 1204-2013
Total Bilirubin Assay Kit Total Bilirubin Assay Kit (Vanadate Oxidation Method), YY/T 1205-2013
Total Cholesterol Determination Kit “Total Cholesterol Determination Kit (Oxidase Method)”, YY/T 1206-2013
Uric Acid Determination Kit “Uric Acid Determination Kit (Uricase Peroxidase Coupling Method)”, YY/T 1207-2013
Creatine Kinase Isoenzyme (CK-MB) Diagnostic Reagent (Box) Creatine Kinase Isoenzyme (CK-MB) Diagnostic Reagent (Box) (Colloidal Gold Method), YY/T 1220-2013
Myocardial Troponin 1 Diagnostic Reagent (Box) “Myocardial Troponin 1 Diagnostic Reagent (Box) (Colloidal Gold Method)”, YY/T 1221-2013
Albumin Assay Reagent (Box) Albumin Assay Reagent (Box), YY/T 1228-2014
Calcium Determination Reagent (Box) Calcium Determination Reagent (Box), YY/T 1229-2014
Cystatin C Assay Reagent (Box) “Cystatin C Assay Reagent (Box)”, YY/T 1230-2014
Creatinine Assay Reagent (Box) Creatinine Assay Reagent (Box) (Creatine Oxidase Method), YY/T 1231-2014
Y-glutamyl Transferase Assay Reagent (Box) (GPNA Substrate Method) Y-glutamyl Transferase Assay Reagent (Box) (GPNA Substrate Method), YY/T 1232-2014
Myocardial Troponin-I Assay Reagent (Box) “Myocardial Troponin-I Assay Reagent (Box) (Chemiluminescence Immunoassay)”, YY/T 1233-2014
Alkaline Phosphatase Assay Reagent (Box) Alkaline Phosphatase Assay Reagent (Box) (NP Substrate AM Buffer Method), YY/T 1234-2014
D-dimer Quantitative Detection Reagent (Box) “D-dimer Quantitative Detection Reagent (Box)”, YY/T 1240-2014
Low Density Lipoprotein Cholesterol Determination Reagent (Box) Low Density Lipoprotein Cholesterol Determination Reagent (Box), YY/T 1253-2015
High Density Lipoprotein Cholesterol Determination Reagent (Box) “High Density Lipoprotein Cholesterol Determination Reagent (Box)”, YY/T 1254-2015
Immuno Turbidimetry Detection Reagent (Box) (Transmission Method) “Immuno Turbidimetry Detection Reagent (Box) (Transmission Method)”, YY/T 1255-2015
Homocysteine Detection Reagent (Box) (Enzyme Cycle Method) “Homocysteine Detection Reagent (Box) (Enzyme Cycle Method)”, YY/T 1258-2015
Time-Resolved Fluorescence Immunoassay Quantitative Assay Reagents (Box) Time-Resolved Fluorescence Immunoassay System-Part 2: Time-Resolved Fluorescence Immunoassay Quantitative Assay Reagents (Box), YY/T 1304.2-2015
Apolipoprotein B Assay Kit Apolipoprotein B Assay Kit, YY/T 1421-2016
β2-microglobulin Quantitative Detection Reagent (Box) β2-microglobulin Quantitative Detection Reagent (Box), YY/T 1442-2016
Total Protein Assay Kit Total Protein Assay Kit, YY/T 1444-2016
Lipoprotein (a) Assay Kit Lipoprotein (a) Assay Kit, YY/T 1448-2016
Apolipoprotein A-I Assay Reagent (Box) Apolipoprotein A-I Assay Reagent (Box), YY/T 1450-2016
Brain Natriuretic Peptide and Amino Terminal Brain Natriuretic Peptide Precursor Detection Kit (Box) Brain Natriuretic Peptide and Amino Terminal Brain Natriuretic Peptide Precursor Detection Kit (Box) (Quantitative Labeling Immunoassay), YY/T 1451-2016
Medical Diagnostic X-ray Tomography Device Technical Requirements for Medical Diagnostic X-ray Tomography Device, YY/T 0202-2009
Hydrogen Peroxide Low Temperature Gas Plasma Sterilizer Hydrogen Peroxide Low Temperature Gas Plasma Sterilizer, GB/T 32309-2015
Enzyme Labeling Analyzer Verification Procedure Enzyme Labeling Analyzer Verification Procedure, JJG 861-2007
EEG Biofeedback Instrument “EEG Biofeedback Instrument”, YY 0903-2013
Disposable Aseptic Entry Needle Disposable Aseptic Entry Needle, GB 15811-2016/ISO 7864:1993
Surgery, Surgical Gowns and Cleansing Machines for Patients, Medical Staff and Equipment Surgery, Surgical Gowns and Cleansing Machines for Patients, Medical Staff and Equipment-Part 4: Test Methods for Dry State, YY/T 0506.4-2016/ISO 9073-10:2003
Disposable Venous Blood Sample Collection Container Determination of the Amount of Additives in A Disposable Venous Blood Sample Collection Container-Part 1: Ethylenediaminetetraacetic Acid (EDTA) Salt, YY/T 1416.1-2016
Disposable Aseptic Catheter Disposable Aseptic Catheter, YY 0325-2016
Disposable Syringe Plunger Disposable Syringe Plunger, YY/T 0243-2016
Disposable Venous Blood Sample Collection Container Determination of the Amount of Additives in A Disposable Venous Blood Sample Collection Container-Part 2: Sodium Citrate, YY/T 1416.2-2016
Titanium and Titanium Alloy Processing Materials for Surgical Implants Titanium and Titanium Alloy Processing Materials for Surgical Implants, GB/T 13810-2007
Surgery, Surgical Gowns and Cleansing Machines for Patients, Medical Staff and Equipment Surgery, Surgical Gowns and Cleansing Machines for Patients, Medical Staff and Equipment-Part 2: Performance Requirements and Test Methods, YY/T 0506.2-2016
Disposable Aseptic Intravascular Catheter Attachment-Part 3: Balloon Compression Devices for Balloon Dilatation Catheters Disposable Aseptic Intravascular Catheter Attachment-Part 3: Balloon Compression Devices for Balloon Dilatation Catheters, YY/T 0450.3-2016
Titanium and Titanium Alloy Dental Implants Titanium and Titanium Alloy Dental Implants, YY 0315-2016
Medical Devices Medical Devices • Glycotoxicity Test-Part 1: Bacterial Reverse Mutation Test, YY/T 0870.1-2013
Medical Devices Biological Evaluation of Medical Devices-Part 3: Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity, GB/T 16886.3-2008/ISO 10993-3:2003
Needle Forceps “Needle Forceps”, YY/T 1031-2016
Ophthalmic Needle Holder Ophthalmic Needle Holder, YY/T 1015-2016
Disposable Abortion Suction Tube Disposable Abortion Suction Tube, YY/T 0979-2016
Dentistry Metal-ceramic System Dentistry Matching Test-Part 1: Metal-ceramic Systems, Y Y0621.1-2016/ISO 9693-1:2012
Medical Suture Needle Medical Suture Needle, YY/T 0043-2016
Acupuncture Needle Acupuncture Needle, GB 2024-2016
Copper for Copper-containing Intrauterine Devices Technical Requirements and Test Methods for Copper for Copper-containing Intrauterine Devices, YY/T 1404-2016
Disposable Human Venous Blood Sample Collection Containers Determination of The Amount of Additives in Disposable Human Venous Blood Sample Collection Containers-Part 3: Heparin, YY/T 1416.3-2016
Indomethacin-containing Silicone Rubber for Copper-containing Intrauterine Devices Technical Requirements and Test Methods for Indomethacin-containing Silicone Rubber for Copper-containing Intrauterine Devices, YY/T 1471-2016
Metal Materials for Dental Fixation and Activity Restoration Metal Materials for Dental Fixation and Activity Restoration, GB 17168-2013
Disposable Intravenous Indwelling Needle Disposable Intravenous Indwelling Needle, YY 1282-2016
Disposable Biopsy Needles Disposable Biopsy Needles-Part 1: General Requirements, YY/T 0980.1-2016
Disposable Biopsy Needles Disposable Biopsy Needles-Part 2: Manual, YY/T 0980.2-2016
Disposable Biopsy Needles Disposable Biopsy Needles-Part 3: Motorized Assembly, YY/T 0980.3-2016
Disposable Biopsy Needles Disposable Biopsy Needles-Part 4: Motor-integrated, YY/T 0980.4-2016
Surgical Implants • Metal Bone Screw Surgical Implants • Metal Bone Screw Rotation Torque Test Method, YY/T 1506-2016
Surgical Implants • Metal Bone Screw Surgical Implants • Test Method for Axial Pull-out Force of Metal Bone Screw, YY/T 1504-2016
Surgical Implants • Metal Bone Screw Surgical Implants • Metal Bone Screw Self-tapping Performance Test Method, YY/T 1505-2016
Surgical Implants • Metal Bone Plate Surgical Implants • Test Method for Bending Fatigue Performance of Metal Plate, YY/T 1503-2016
Bone Joint Implants • Metal Bone Screw Bone Joint Implants • Metal Bone Screw, YY 0018-2016
Bone Joint Implants • Metal Bone Plate Bone Joint Implants • Metal Bone Plate,YY 0017-2016
Thoracic Small Incision Instrument Thoracic Small Incision Instrument-Part 1: Skate Type Surgical Forceps, YY/T 1472.1-2016
Skin Stapler Skin Stapler, YY/T 1415-2016
Disposable Umbilical Cord Scissors (Cut) Disposable Umbilical Cord Scissors (Cut), YY/T 1470-2016
Disposable Facial Irrigator Disposable Facial Irrigator, YY/T 0981-2016
Dentistry • Orthodontic Elastomeric Attachments Dentistry • Orthodontic Elastomeric Attachments, YY/T 0624-2016/ISO 21606:2007
Dentistry • Orthodontic Wire Dentistry • Orthodontic Wire, YY/T 0625-2016/ISO 15841:2006
Medical Metal Clip Medical Metal Clip, YY/T 0079-2016
Vascular Stents Cardiovascular Implants • Endovascular Devices-Part 2: Vascular Stents, YY/T 0663.2-2016
Medical Instruments Medical Infusion, Blood Transfusion, Injectables-Test Methods-Part 2: Biological Test Methods, YY/T 14233.2-2005
Medical Instruments Biological Evaluation of Medical Devices-Part 4: Selection of Test for Interaction with Blood, GB/T 16886.4-2003
Medical Electrical Equipment Medical Electrical Equipment-Part 1-2: General Requirements for Basic Safety and Performance-Parallel Standard: Electromagnetic compatibility requirements and tests IEC 60601-1-2:2014
Implantable Infusion Pumps “Surgical Implants • Active Implantable Medical Devices-Part 4: Implantable Infusion Pumps, ISO 14708-4:2008
Medical Mammography Digital X-ray Detector Medical Mammography Digital X-ray Detector, YY/T 1307-2016
X-ray Computed Tomography Equipment Technical Requirements for 64-slice Spiral X-ray Computed Tomography Equipment, YY/T 1417-2016
Medical Ultrasound Equipment Environmental Requirements and Test Methods for Medical Ultrasound Equipment, YY/T 1420-2016
Oral X-ray Digital Tomography Equipment Oral X-ray Digital Tomography Equipment Bone Density Measurement and Evaluation Method, YY/T 1466-2016
Electrophysiological Mapping Catheter Electrophysiological Mapping Catheter, YY/T 1519-2017
High Voltage Cable Assemblies and Sockets for Mammography Machines Technical Requirements for High Voltage Cable Assemblies and Sockets for Mammography Machines, YY/T 1541-2017
Digital Medical X-ray Equipmen Digital Medical X-ray Equipment Automatic Exposure Control Evaluation Method, YY/T 1542-2017
Medical Dynamic Digital X-ray Image Detector Medical Dynamic Digital X-ray Image Detector, YY/T 0934-2014
Weight Loss Gait Training Rehabilitation Equipment Weight Loss Walking Training Platform, YY 0900-2013
Weight Loss Gait Training Rehabilitation Equipment Rehabilitation Training Equipment Safety General Requirements, GB 24436-2009
Ethylene Oxide Sterilizer Ethylene Oxide Sterilizer, YY 0503-2016
Portable Steam Sterilizer Portable Steam Sterilizer, YY 0504-2016
Steam Sterilizer Biosafety Performance Requirements for Steam Sterilizer, YY 1277-2016
Cleaning Sterilizer Cleaning Sterilizer-Part 4: Requirements and Tests for Sterilizing and Sterilizing Devices for Non-invasive Medical Devices, YY/T 0734.4-2016
Ultrasonic Cleaning Sterilizer Cleaning Sterilizer – Ultrasonic Cleaning Requirements and Tests, YY/T 1309-2016
Oxygen Concentrator Gas Supply System Oxygen Concentrator Gas Supply System for Medical Gas Pipeline Systems, YY 1468-2016
Anesthesia and Respiratory Equipment Oropharyngeal Airway Anesthesia and Respiratory Equipment Oropharyngeal Airway, YY/T 0977-2016
Anesthesia Reservoir Anesthesia Reservoir, YY/T 0978-2016
Throat Ventilation and Joints on Anesthesia and Respiratory Equipment Throat Ventilation and Joints on Anesthesia and Respiratory Equipment, YY/T 0985-2016
Expiratory Peak Flow Meter Anesthesia and Respiratory Equipment Expiratory Peak Flow Meter for Evaluating Lung Function in Spontaneously Breathing Persons, YY/T 1438-2016
Keratometer Ophthalmic Instrument Keratometer, YY 0579-2016
Teeth Whitening Luminometer Teeth Whitening Luminometer, YY/T 1401-2016
Red Light Treatment Equipment Red Light Treatment Equipment, YY/T 1496-2016
Potential Therapy Equipment Potential Therapy Equipment, YY 0649-2016
Thermal Pad Therapy Unit Thermal Pad Therapy Unit, YY/T 0165-2016
Electric Cervical and Lumbar Traction Treatment Equipment Electric Cervical and Lumbar Traction Treatment Equipment, YY/T 0697-2016
Dental Treatment Machines Dentistry-Dental Treatment Machines-Part 1: General Requirements and Test Methods, YY/T 1043.1-2016
Balance Test Training System Balance Test Training System, YY/T 1410-2016
Portable Electric Infusion Pump Portable Electric Infusion Pump, YY/T 1469-2016
Electric Cervical and Lumbar Traction Bed, Chair and Attachment Electric Cervical and Lumbar Traction Bed, Chair and Attachment, YY/T 1491-2016
Implantable Cardiac Pacemaker “Surgical Implants • Active Implantable Medical Devices-Part 2: Cardiac Pacemaker”, GB 16174.2-2015/ISO 14708-2:2005
Implantable Cardiac Pacemaker “Surgical Implants • Active Implantable Medical Devices-Part 1: General Requirements for Safety, Marking and Information Provided by the Manufacturer, GB 16174.1-2015/ISO 14708-1:2000
Electrode Lead of Implantable Cardiac Pacemaker Electrode Lead of Implantable Cardiac Pacemaker,YY/T 0492-2017
Medical Electron Accelerator Medical Electron Accelerator Performance and Test Methods, GB 15213-2016
Medical Electron Accelerator Safety of Radiotherapy Record and Verification System for Medical Electrical eEquipment, YY 0721-2009
Medical Electron Accelerator High-energy X(γ) Beam Dose Calculation Accuracy for Teletherapy Planning System, YY 0775-2010
Hemodialysis and Related Treatments Hemodialyzers, Hemodiafiltration Filters, Hemofilters and Blood Concentrators Hemodialysis and Related Treatments Hemodialyzers, Hemodiafiltration Filters, Hemofilters and Blood Concentrators, YY 0053-2016
Extracorporeal Blood Circuit for Hemodialysis and Related Treatment Blood Purification Devices Extracorporeal Blood Circuit for Hemodialysis and Related Treatment Blood Purification Devices, YY 0267-2016
Dialysate Filter Dialysate Filter, YY 1272-2016
Cochlear Implant System “Surgical Implants • Active Implantable Medical Devices-Part 7: Special Requirements for Cochlear Implant Systems”, YY 0989.7-2017

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Personal Protection Equipments

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Eye Standards: EN166:2001
EN170-2002
EN171-2002
EN169-2003
EN175-1997
EN379-2003
EN1731-2006

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