YY/T 0772.3-2009Implants for surgery Ultra-high-molecular-weight polyethylene - Part 3: Accelerated ageing methods (English PDF)
外科植入物 超高分子量聚乙烯 第3部分:加速老化方法
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
December 30, 2009
Implementation date
June 1, 2011
Scope
YY/T 0772.3-2009 is the English-translated version of 外科植入物 超高分子量聚乙烯 第3部分:加速老化方法.
YY/T 0772.3-2009 is a recommended Chinese medical device industry standard and forms the third part of the series on ultra-high-molecular-weight polyethylene for surgical implants.
It sets out an accelerated ageing method for judging the oxidation stability of UHMWPE once the material has been processed and sterilized. Samples and components intended for total joint prostheses are held in oxygen under pressure at raised temperature so that oxidation of the polymer is speeded up.
The condition reached in this way is then used to assess the long-term chemical and mechanical stability the material can be expected to keep. It quotes GB/T 19701.1, GB/T 21461.1, GB/T 21461.2 and ASTM F2003-2002. Issued on 30 December 2009, it has applied since 1 June 2011.
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Document preview — YY/T 0772.3-2009
National Standard of the People's Republic of China
- ICS
- 11.040.40
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- 2 Normative references
2 Normative references
YY/T 0772.3-2009 cites the following standards, which apply in full or in part through the references made to them in its clauses.
GB/T 19701.1
GB/T 21461.1
GB/T 21461.2
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 19701.1Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 1: Powder form
- GB/T 21461.1Plastics - Ultra-high-molecular-weight polyethylene (PE-UHMW) moulding and extrusion materials - Part 1: Designation system and basis for specifications
- GB/T 21461.2Plastics - Ultra-high-molecular-weight polyethylene (PE-UHMW) moulding and extrusion materials - Part 2: Preparation of test specimens and determination of properties
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Related Standards
GB/T 19701.1-2024 — Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 1: Powder form
GB/T 21461.1-2023 — Plastics - Ultra-high-molecular-weight polyethylene (PE-UHMW) moulding and extrusion materials - Part 1: Designation system and basis for specifications
GB/T 21461.2-2023 — Plastics - Ultra-high-molecular-weight polyethylene (PE-UHMW) moulding and extrusion materials - Part 2: Preparation of test specimens and determination of properties
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