YY 0502-2005 Knee joint prostheses

YY 0502-2016 Joint replacement implants—Knee joint prostheses

ISO 7207-1 ISO 7207-2 ISO 13779-2 ISO 14630 ISO 21534 ISO 21536 ISO 6474 ISO 13356 YY 0117-2005(所有部分) GB/T 2828.1-2003 Sampling procedures for inspection by attributes—Part 1:Sampling schemes indexed by acceptance quality limit(AQL) for lot-by-lot inspection GB/T 2828.1-2012 Sampling procedures for inspection by attributes—Part 1:Sampling schemes indexed by acceptance quality limit(AQL) for lot-by-lot inspection GB/T 2829-2002 Sampling procedures and tables for periodic inspection by attributes (Apply to inspection of process stability) GB/T 14233.1-1998 Infusion,transfusion,injection equipment for medical use—Part 1:Chemical analysis methods GB/T 14233.1-2008 Test methods for infusion,transfusion,injection equipments for medical use—Part 1:Chemical analysis methods GB/T 14233.1-2022 Test methods for infusion,transfusion,injection equipments for medical use—Part 1:Chemical analysis methods GB/T 14233.2-1993 Infusion, transfusion, injction equipment for medical use—Part 2:Biological test methods GB/T 14233.2-2005 Test methods for infusion,transfusion,injection equipment for medical use—Part 2:Biological test methods GB/T 16886.7-2001 Biological evaluation of medical devices—Part 7:Ethylene oxide sterilization residuals GB/T 16886.7-2015 Biological evaluation of medical devices—Part 7:Ethylene oxide sterilization residuals GB/T 19701.2-2005 Implants for surgery Ultra-high molecular weight polyethylene—Part 2:Moulded forms GB/T 19701.2-2016 Implants for surgery—Ultra-high-molecular-weight polyethylene—Part 2:Moulded forms GB/T 19633-2005 Packaging for terminally sterilized medical devices GB/T 19633.1-2015 Packaging for terminally sterilized medical devices—Part 1:Requirements for materials, sterile barrier systems and packaging systems GB/T 19633.1-2024 Packaging for terminally sterilized medical devices—Part 1:Requirements for materials,sterile barrier systems and packaging systems GB/T 19633.2-2015 Packaging for terminally sterilized medical devices—Part 2:Validation requirements for forming,sealing and assembly processes GB/T 19633.2-2024 Packaging for terminally sterilized medical devices—Part 2:Validation requirements for forming,sealing and assembly processes YY 0341-2002 General technological requirements for non-active metallic surgery implants of osteosynthesis YY 0341.1-2020 Non-active surgical implants—Osteosynthesis and spinal implants—Part 1:Particular requirements for osteosynthesis implants YY 0341.2-2020 Non-active surgical implants—Osteosynthesis and spinal implants—Part 2:Particular requirements for spinal implants YY/T 0343-2002 Liquid penetrant inspection of metallic surgical implants GB/T 19701.2-2024 Implants for surgery—Ultra-high-molecular-weight polyethylene—Part 2:Moulded forms HB/Z 60-1996 X-ray photography inspection GB/T 14233.2-2025 Test methods for infusion,transfusion,injection equipment for medical use—Part 2:Biological test methods GB/T 2829-2025 Sampling procedures and tables for periodic inspection by attributes(Apply to inspection of process stability)