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YY/T 0809.8-2010 English PDF (YYT0809.8-2010)

YY/T 0809.8-2010 English PDF (YYT0809.8-2010)

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YY/T 0809.8-2010: Implants for surgery. Partial and total hip joint prostheses. Part 8: Endurance performance of stemmed femoral components with application of torsion

YY/T 0809.8-2010
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.40
C 35
Implants for surgery - Partial and total hip joint prostheses -
Part 8: Endurance performance of stemmed femoral
components with application of torsion
(ISO 7206-8:1995, MOD)
ISSUED ON: DECEMBER 27, 2010
IMPLEMENTED ON: JUNE 01, 2012
Issued by: China Food and Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative references ... 4
3 Test conditions ... 4
4 Endurance performance ... 4
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.
Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents. Implants for surgery - Partial and total hip joint prostheses -
Part 8: Endurance performance of stemmed femoral
components with application of torsion
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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