YY/T 0809.8-2010Implants for surgery—Partial and total hip joint prostheses - Part 8: Endurance performance of stemmed femoral components with application of torsion (English PDF)
外科植入物 部分和全髋关节假体 第8部分：有扭矩作用的带柄股骨部件疲劳性能
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
December 27, 2010
Implementation date
June 1, 2012
Scope
YY/T 0809.8-2010 is the English-translated version of 外科植入物 部分和全髋关节假体 第8部分：有扭矩作用的带柄股骨部件疲劳性能.
YY/T 0809.8-2010 is the Chinese pharmaceutical industry standard that specifies the endurance performance of the stemmed femoral component of a partial or total hip joint prosthesis under laboratory conditions with the application of torsion.
It is the eighth part of the YY/T 0809 series and sets out the embedding of the stem, the loading and the torsional moment applied, the frequency and the number of cycles and the examination of the component afterwards. Issued on 27 December 2010, it applies from 1 June 2012.
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Document preview — YY/T 0809.8-2010
National Standard of the People's Republic of China
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword3
- 1 Scope4
- 2 Normative references4
- 3 Test conditions4
- 4 Endurance performance4
Foreword
YY/T 0809 Implants for surgery - Partial and total hip joint prostheses is expected to be divided into the following parts:
-- Part 1: Classification and designation of dimensions;
-- Part 2: Articulating surfaces made of metallic, ceramic and plastics materials;
-- Part 4: Determination of endurance properties of stemmed femoral components;
-- Part 6: Determination of endurance properties of head and neck region of stemmed femoral components;
-- Part 8: Endurance performance of stemmed femoral components with application of torsion;
-- Part 10: Determination of resistance to static load of modular femoral heads. This Part is Part 8 of YY/T 0809.
This Part is drafted in accordance with the rules given in GB/T 1.1-2009.
This Part uses the redraft method to modify and adopt ISO 7206-8:1995 Implants for surgery - Partial and total hip joint prostheses - Part 8: Endurance performance of stemmed femoral components with application of torsion.
Compared with ISO 7206-8:1995, this Part only makes adjustment of technical differences to the normative references, so as to adapt to the technical conditions of our country. The adjustments are mainly reflected in Clause 2 "Normative references", with details listed as below:
-- Use YY/T 0809.4-2010 to replace ISO 7206-4:1989.
1 Scope
This Part of YY/T 0809 specifies the endurance performance of stemmed femoral components of partial and total hip joint prostheses under specified laboratory conditions by a method that includes the application of torsion. This Part does not apply to the following:
a) prostheses for special clinical cases;
b) prostheses for which the centerline of the stem is three-dimensionally curved and does not lie in any plane in which the axis of the neck lies.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
YY/T 0809.4-2010, Implants for surgery - Partial and total hip joint prostheses - Part 4: Determination of endurance properties of stemmed femoral components (ISO 7206-4:2002, MOD)
3 Test conditions
The femoral component shall be tested in its ready-for-use condition. […]
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
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Related Standards
YY/T 0809.4-2010 — Implants for surgery—Partial and total hip joint prostheses - Part 4: Determination of endurance properties of stemmed femoral components
YY/T 0809.10-2022 — Implants for surgery-Partial and total hip-joint prostheses - Part 10: Determination of resistance to static load of modular femoral heads
YY/T 0809.6-2010 — Implants for surgery—Partial and total hip joint prostheses - Part 6: Determination of endurance properties of head and neck region of stemmed femoral components
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