YY/T 0963-2014 English PDF

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YY/T 0963-2014: Joint replacement implants. Shoulder prosthese
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 0963-2014	279	Add to Cart	3 days	Joint replacement implants. Shoulder prosthese	Valid

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Basic data

Standard ID: YY/T 0963-2014 (YY/T0963-2014)
Description (Translated English): Joint replacement implants. Shoulder prosthese
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C35
Classification of International Standard: 11.040.40
Word Count Estimation: 12,172
Date of Issue: 6/17/2014
Date of Implementation: 7/1/2015
Quoted Standard: GB/T 14233.1; GB/T 14233.2; GB/T 16886.1; GB/T 16885.7; GB 18278; GB 18279; GB 18280; GB/T 19701.2; YY 0117.1; YY 0117.2; YY 0117.3; YY/T 0605.5; YY/T 0605.6; YY/T 0605.8; YY 0605.12; ISO 4287; ISO 5832-1; ISO 6474-1; ISO 21534-2007; ASTM F746; ASTM F1044
Adopted Standard: ISO 21534-2007, NEQ; ASTM F1378-2005, NEQ
Regulation (derived from): China Food and Drug Administration in 2014 Bulletin No. 30
Issuing agency(ies): State Food and Drug Administration
Summary: This Standard applies to the glenoid and humeral components parts and joint action to provide functional partial or total shoulder prosthesis and modular prosthesis. This Standard specifies the classification shoulder prosthesis, materials, design evaluat

YY/T 0963-2014: Joint replacement implants. Shoulder prosthese

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Joint replacement implants.Shoulder prosthese ICS 11.040.40 C35 People's Republic of China pharmaceutical industry standards Shoulder joint replacement implant prosthesis Issued on. 2014-06-17 2015-07-01 implementation China Food and Drug Administration released

Foreword

This standard was drafted in accordance with GB/T 1.1-2009 given rules. The standard reference method using redrafted ISO 21534.2007 "active surgical implants - Joint replacement implants - Particular requirements" and ASTMF1378-2005 "shoulder prosthesis standards." Technical differences between this standard and ASTMF1378-2005 follows. --- Deleted the original Chapter 10, "keyword"; --- In Appendix X1 to Appendix A, contents remain unchanged; --- According to ISO 21534.2007 adds Chapter 7, "manufacturing", Chapter 8, "sterilization," Chapter 9, "packaging"; --- Adopt ISO standards, national standards and industry standards instead of the corresponding US standards. Please note that some of the content of this document may involve patents. Release mechanism of the present document does not assume responsibility for the identification of these patents. This standard was proposed by the China Food and Drug Administration. This standard by the national surgical implants and orthopedic instruments Standardization Technical Committee materials and orthopedic implants Technical Committee (SAC / TC110/SC1) centralized. This standard was drafted. Tianjin Medical Device Quality Supervision and Inspection Center, Beijing high-tech Co., Ltd. Air Materiel Bermuda. The main drafters of this standard. Dongshuang Peng, Tao Kai, Zhang Lu, Zhang said, Liang Fanghui, Bai Jianfeng. Shoulder joint replacement implant prosthesis

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] ......

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