(I) Biocompatibility Test for Medical Devices
GB/T 16886.3 Biological Evaluation of Medical Devices Part 3: Genotoxicity, Carcinogenicity and Reproductive Toxicity Test
GB/T 16886.4 Biological Evaluation of Medical Devices Part 4: Selection of Tests for Interaction with Blood
GB/T 16886.5 Biological evaluation of medical devices Part 5: In vitro cytotoxicity test
GB/T 16886.6 Biological evaluation of medical devices Part 6: Post-implantation local reaction test
GB/T 16886.7 Biological evaluation of medical devices Part 7: Residual amount of ethylene oxide sterilization
GB/ T 16886.8 Biological evaluation of medical devices Part 8: Selection and characterization of reference samples for biological tests
GB/T 16886.10 Biological evaluation of medical devices Part 10: Irritation and sensitization test
GB/T 16886.11 Biological evaluation of medical devices Part 11: Systemic toxicity test
GB/T 16886.12 Biological evaluation of medical devices Part 12: Sample preparation and reference samples
GB/T 16886.13 Biological evaluation of medical devices Part 13: Characterization and quantification of degradation products of polymeric medical devices
GB/T 16886.14 Biological evaluation of medical devices Part 14: Characterization and quantification of ceramic degradation products
GB/T 16886.14 Biological evaluation of medical devices Part 14: Qualitative and Quantitative analysis
GB/T 16886.15 Biological evaluation of medical devices Part 15: Qualitative and quantitative degradation products of metals and alloys
GB/T 16886.16 Biological evaluation of medical devices Part 16: Toxicokinetic study design of degradation products and soluble substances) GB/T 16886.17 Biological evaluation of medical devices Part 17: Determination of degradation products based on health risk evaluation
GB/T 16886.17 Biological evaluation of medical devices Part 17: Determination of degradation products based on health risk assessment
GB/T 16886.19 Biological evaluation of medical devices Part 19: Physical, chemical, mechanical and morphologic characterization of materials
GB/T 16886.20 Medical devices Biological evaluation Part 20: Principles and methods of immunotoxicology test for medical devices
GB/T16175 Test methods for biological evaluation of medical silicone materials
GB/T 16886.9 Biological evaluation of medical devices Part 9: General rules for the characterization and quantification of potential degradation products
YY/T 0473 Surgical Implants Polysubstituted ester ***. **Polymers and *** blends In vitro degradation test
YYY/T 0474 Poly L-propylene glycol resins and products for surgical implants In vitro degradation test
YYY/T XXXX Requirements for biological evaluation of disposable rubber gloves and test methods
GB /TXXXX Medical devices Microbiology Part 3: Bacterial endotoxin test methods For routine monitoring and skip batch testing
GB /TXXXX Medical devices Microbiology Part 3: Bacterial endotoxin test method Monitoring and skip batch testing
YYY/T 0567.1 Aseptic processing of medical products Part 1: General requirements
YYY/T 0567.2 Aseptic processing of medical products Part 2: Filtration
GB XXXX.1 Animal tissues and their derivatives used in the production of medical devices Part 1: Risk analysis and management
GB XXXX.2 Animal tissues and their derivatives for the production of medical devices Part 2: source of claim, collection and disposal
GB XXXX.3 Animal tissues and their derivatives for the production of medical devices Part 3: removal and inactivation of viruses and vectors
GB XXXX.4 Animal tissues and their derivatives for the production of medical devices Part 4: confirmation of the sterilizing agent sterilizing liquids And routine control (B) medical transfusion (blood), injection apparatus standards
GB/T14233.1 medical transfusion, blood transfusion, injection apparatus test methods Part 1: chemical analysis methods
GB/T14233.2 medical transfusion, blood transfusion, injection apparatus test methods Part 2: biological test methods
GB15593 blood transfusion (liquid) ) apparatus with soft polyvinyl chloride plastic
YYY0114 medical infusion, blood transfusion, syringe with polyethylene special materials
YYY0242 medical infusion, blood transfusion, syringe with polypropylene special materials
GB 8368 single-use infusion set
GB 18671 disposable intravenous needles
YY Part 4: Single-use infusion sets for pressure infusion devices
YYY 0286.5 Specialized infusion sets Part 5: Single-use infusion sets for hanging bottles and dispensing bags
YYY 0286.6 Specialized infusion sets Part 6: Single-use non-PVC infusion sets
YYY 0286.7 Specialized infusion sets Part 7: Single-use infusion sets for flow rate setting
YY 0286.7 Specialized infusion sets Part 7: Single-use infusion sets for flow rate setting
YYY 0286.8 Specialized infusion sets Part 8: Single-use infusion sets for infusion sets, gravity infusion type
YY XXXX Disposable intravenous nutrition bag
YY 0451 Disposable infusion pump
YY XXXX Disposable hyperbaric infusion set
YY 0585.1 Disposable fluid line and accessory for pressure infusion equipment Part 1: Fluid line
YY 0585.2 Fluid line for pressure infusion equipment
YY 0585.2 Fluid line for pressure infusion equipment
YY 0585.2 Fluid line for pressure YY 0585.2 Single-use fluid lines and accessories for pressure infusion equipment Part 2: Accessories
YYY 0585.3 Single-use fluid lines and accessories for pressure infusion equipment Part 3: Filters
YYY 0585.4 Single-use fluid lines and accessories for pressure infusion equipment Part 4: Antireflux valves
YYY 0586 Heparin caps for infusion
YY/T 0582.1 Infusion equipment, single-use fluid lines for pressure infusion, single-use fluid lines for pressure infusion and accessories Part 3: Filters
YYY/T 0582.2 Infusion bottle suspension device Part 2: Multi-purpose suspension device
GB8369 Single-use blood transfusion device
GB 14232.1 Bagged plastic containers of human blood and blood components Part 1: Traditional blood bags
GB 14232.1 Blood and blood components bagged plastic containers Part 1: Traditional blood bags
GB 14232.2 Human blood and blood components bag-type plastic containers Part 2: graphic symbols
GB 14232.3 Human blood and blood components bag-type plastic containers Part 3: blood bag system with special components YY 0327 Single-use ultraviolet translucent therapy blood containers
GB 19335 Single-use blood circuit products General Technical conditions
YYY0113 disposable blood collection device
YYY 03282 disposable blood collection device
YYY 0326.1 Disposable centrifugal plasma separator Part 1: plasma separator cup
YYY 0326.2 Disposable centrifugal plasma separator Part 2: plasma pipeline
YY 0326.3 Single-use centrifugal plasma separator Part 3: plasma bag
YYY 0329-2009 Single-use leukocyte removal filter
YYY0031 Silicone rubber infusion tubes
YYY 0584 Single-use centrifugal cup-type blood component separation equipment
YYY XXXX Disposable centrifugal bag type blood component separation equipment
YYY/T 0289 Disposable micro-volume blood collection pipette
YYY 0314 Disposable human venous blood sample collection container
YYY 0464-2009 Disposable blood perfusion device
YYY 0465-2009 Disposable hollow blood tube
GB 15810 Disposable sterile syringe
GB 15811 Disposable sterile injection needle
YY/T 0243 Disposable sterile syringe with rubber piston
YY/T 0282 -2009 Syringe needle
(C) Standards for medical catheters and cannulae
YYY 0285.1 Disposable sterile intravascular catheters Part 1: General requirements
YYY 0285.2 Disposable sterile intravascular catheters Part 2: Imaging catheters
YYY 0285.3 Disposable sterile intravascular catheters Sterile intravascular catheters Part 3: central venous catheters
YYY 0285.4 Single-use sterile intravascular catheters Part 4: balloon dilatation catheters
YYY 0285.5 Single-use sterile intravascular catheters Part 5: peripheral catheters for lancing needles
YY/T 0586 X-ray Impermeability Test Methods for Polymer Products for Medical Use
YYY 0450.1 Single-use sterile intravascular catheter accessories Part 1: guide device
YYY 0450.2 Single-use sterile intravascular catheter accessories Part 2: Sleeve needle peripheral catheter tubing plugs
YYY 0450.3 Single-use sterile intravascular catheter accessories Part 3: balloon dilatation catheter dilatation pump
GB/T15812.1 Medical polymer products X-ray impermeability test method
GB/T15812.2 Non-vascular catheter Part 2: Bending performance test method
YYY 0030 Peritoneal dialysis tubing
YYY 0325 Single-use sterile urinary catheter
YYY 0489 Single-use sterile drainage catheter and its auxiliary equipment
YYY 0450.3 Single-use sterile intravascular catheter accessories and its auxiliary devices
YYY 0488 Disposable sterile rectal catheters
YYY 0483 Disposable enteral nutrition catheters, enteral feeders and their connectors Design and test methods
YYY 1040.1 Anaesthesia and respiratory equipment Conical connectors Part 1: Conical head and conical sleeve
YYY 0337.1 Tracheal intubation Part 1: Commonly used intubation tubes and connectors
YY 0337.2 Tracheal intubation Part 2: Cole-type intubation tubes
YY 0338.1 Tracheotomy intubation Part 1: Intubation tubes and connectors for adults
YY 0338.2 Tracheotomy intubation Part 2: Tracheotomy intubation tubes for pediatrics
YY 0339 2009 Suction catheters for respiratory tract
YYY 0461 Breathing lines for anesthesia and respiratory machines
(IV) Standard for sterile implants
YYY 0484 Surgical implants Two-component plus molding vulcanized silicone rubber
YYY 0334 General requirements for silicone rubber surgical implants
YY 0332 Implantable drug delivery devices
YYY 0333 Soft tissue expander
YYY 0487 Single-use sterile hydrocephalus shunt and its components
YYY0308 Sodium hyaluronate gel for medical use
YYY/TXXXX medical natural polymer degradation of polysaccharide materials: general requirements and test methods
(V) Hygienic materials, dressings
YYY/T 0471.1 Contact wound dressing test method Part 1: Liquid absorption
YYY /T 0471.2 Contact wound dressing test method Part 2: Breathable film dressing water vapor transmission rate
YY/T 0471.3 Test method for contact wound dressing Part 3: water resistance
YY/T 0471.3 Test method for contact wound dressing: water barrier
YY/T 0471.4 Contact wound dressing: water vapour transmission rate
YY/T 0471.4 Test Methods for Contact Wound Dressings Part 4: ComfortYY/T 0471.5 Test Methods for Contact Wound Dressings Part 5: Bacterial Resistance
YY/T 0471.6 Test Methods for Contact Wound Dressings Part 6: Odor Control
YY/T 0471.7 Test Methods for Trauma Dressings Part 7: Particle Shedding
YYY /T0471.8 Test Methods for Trauma Dressings Part 8: Adhesion (wound and skin)
YYY/T 0472.1 Test Methods for Non-woven Dressings for Medical Purposes Part 1: Non-woven Fabrics for the Production of Dressings
YYY/T 0472.2 Test Methods for Non-woven Dressings for Medical Purposes Part 2: Finished Dressings
YYY 0330 medical skimmed cotton
YYY 0331 Skimmed cotton gauze and skimmed cotton and adhesive gauze performance requirements and test methods
YYY 0594 General requirements for surgical gauze dressings
YY/T 0148 General requirements for medical adhesive tape
YYY/T 0506.2- 2009 Surgical sheets, gowns and clean garments for patients, healthcare workers and instruments Part 2: Performance requirements and performance levels YY/T 0506.3 Surgical sheets, gowns and clean garments for patients, healthcare workers and instruments Part 3: Test methods
YYY/T 0506.4 Surgical sheets, gowns and clean garments for patients, healthcare workers and instruments Part 4: Dry flocculation Test methods
YY/T 0506.5-2009 Surgical slips, gowns and clean garments for patients, healthcare workers and instruments Part 5: Dry bacterial barrier test methods
YY/T 0506.6-2009 Surgical slips, gowns and clean garments for patients, healthcare workers and instruments Part 6: Wet bacterial barrier test methods
YY/T 0506.6-2009 Surgical slips, gowns and clean garments for patients, healthcare workers and instruments Part 6: Wet bacterial barrier test methods Part 6: Wet state bacteriostatic test methods
YYY/T 0506.7 Surgical sheets, gowns and clean clothing for patients, health care workers and instruments Part 7: Test methods for blocking the penetration of contaminating aerosols
YYY/T 0506.8 Surgical sheets, gowns and clean clothing for patients, health care workers and instruments Part 8: Test methods for resistance to lasers
(F) Other standards
YYY/T 0720-2009 Disposable delivery bag for natural childbirth
YYY 0321.1-2009 Disposable anesthesia puncture kit
YYY 0321.2-2009 Disposable anesthesia Needles for anesthesia
YYY 0583-2005 Disposable Chest Drainage Device Water Seal Type
YYY 0167 Non-absorbable Surgical Sutures
YYY 1116 Absorbable Surgical Sutures
GB 7543-1996 Rubber medical gloves
GB 10213- 1995 Disposable rubber examination gloves
GB 7544-2004 Technical requirements and test methods for natural latex rubber condoms* (non-sterile medical devices)
YY /T0698.1-2009 Packaging materials for final sterilized medical devices Part 1: Blow-molded composite plastic film Requirements and test methods
YY /T0698.1-2009 Packaging materials for final sterilized medical devices Part 1: Blow-molded composite plastic film Requirements and test methods
YY /T0698.2-2009 Packaging materials for ultimately sterilized medical devices Part 2: Sterilized wrapping materials Requirements and test methods
YY /T0698.3-2009 Packaging materials for ultimately sterilized medical devices Part 3: Paper bags, combination bags and rolls of production paper Requirements and test methods
YY /T0698.3-2009 Packaging materials for ultimately sterilized medical devices Part 3: Paper bags, combination bags and rolls of production paper Requirements and test methods
YYY /T0698.5-2009 Packaging materials for medical devices for final sterilization Part 5: Heat-sealed and self-sealed bags and rolls combining paper and plastic film Requirements and test methods;
YY /T0698.5-2009 Packaging materials for medical devices for final sterilization Part 5: Heat-sealed and self-sealed bags and rolls combining paper and plastic film Part 5: Requirements and test methods for heat-sealed and self-sealed bags and rolls combined with paper and plastic film;
YYY /T0698.6-2009 Packaging materials for ultimately sterilized medical devices Part 6: Requirements and test methods for paper used in the production of aseptic barrier systems used for low-temperature sterilizing processes or radiation sterilization;
YYY /T0698.7-2009 Packaging materials for ultimately sterilized medical devices Part 7: Ethylene oxide (EO) packaging materials Packaging materials for ultimately sterilized medical devices Part 7: Sealable adhesive coated paper for the production of medical sterile barrier systems for ethylene oxide or radiation sterilization Requirements and test methods;
YY /T0698.8-2009 Packaging materials for ultimately sterilized medical devices Part 8: Reusable sterilizing containers for steam sterilizers Requirements and test methods for ultimately sterilized medical devices Part 9: Reusable sterilizing containers for steam sterilizers