YY/T 0963-2014Joint replacement implants—Shoulder prostheses (English PDF)

1 Scope

This standard specifies the terms and definitions joint replacement implant --- shoulder prosthesis, classification, materials, design evaluation, manufacturing, sterilization, package

Equipment, manufacturers should provide information.

This standard applies to the glenoid and humeral components and parts provide a functional part of the joint action or total shoulder prosthesis.

This standard does not apply to custom-made prosthesis. Modular prosthesis apply to this standard.

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein

Member. For undated references, the latest edition (including any amendments) applies to this document.

GB/T 14233.1 Infusion, transfusion, injection equipment - Part 1. Chemical analysis

GB/T 14233.2 Infusion, transfusion, injection equipment test methods - Part 2. Biological test methods

GB/T 16886.1 Biological evaluation of medical devices - Part 1. Test Selection Guide (GB/T 16886.1-2011, ISO 10993-

1.2009, IDT)

GB/T 16886.7 Biological evaluation of medical devices - Part 7. Ethylene oxide sterilization residuals (GB/T 16886.7-2001, idt

ISO 10993-7.1995)

GB 18278 Sterilization of health care products industry validation and routine control of moist heat sterilization (GB 18278-2000, idtISO

11134.1994)

GB 18279 Medical Devices ethylene oxide sterilization validation and routine control (GB 18279-2000, idtISO 11135.1994)

GB 18280 Sterilization of health care products requires validation and routine control of radiation sterilization (GB 18280-2000, idtISO

11137.1995)

GB/T 19701.2 ultra-high molecular weight polyethylene - Part 2. molded plastic (GB/T 9701.2-2005, ISO 5834-2.1998,

IDT)

YY 0117.1 surgical implant bone joint prosthesis forging, casting Ti6A14V titanium forgings

YY 0117.2 surgical implant bone joint prosthesis forging, casting ZTi6A14V Titanium Castings

YY 0117.3 surgical implant bone joint prosthesis forging, casting cobalt-chromium-molybdenum alloy castings

YY/T 0605.5 surgical implants of metallic materials - Part 5. Wrought cobalt - chromium - tungsten - nickel alloy (YY/T 0605.5-2007,

ISO 5832-5.2005, IDT)

YY/T 0605.6 surgical implants of metallic materials - Part 6. Wrought cobalt - nickel - chromium - molybdenum alloy (YY/T 0605.5-2007,

ISO 5832-6.1997, IDT)

YY/T 0605.8 surgical implants of metallic materials - Part 8. Wrought cobalt - nickel - chromium - molybdenum - tungsten - iron alloy (YY/T 0605.8-

2007, ISO 5832-8.1997, IDT)

YY 0605.12 surgical implants of metallic materials - Part 12. Wrought cobalt - chromium - molybdenum alloy (YY/T 0605.12-2007, ISO 5832-12.1996, IDT)

ISO 4287 Geometrical product specifications (GPS) - Surface texture. Profile method - Terms, definitions and surface texture parameters

[Geometricalproductspecification (GPS) -Surfacetexture. Profilemethod-Terms, definitionsand surfacetextureparameters] […]