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Norm
ÖNORM EN ISO 21534
Issue date: 2009 08 01
Non-active surgical implants - Joint replacement implants - Particular requirements (ISO 21534:2007)
This International Standard specifies particular requirements for total and partial joint replacement implants, artificial ligaments and bone cement, hereafter referred t...
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Publisher:
Austrian Standards International
Format:
Digital | 22 Pages
Language:
German
| English
| Download GER/ENG
Optionally co-design standards:
ICS
This International Standard specifies particular requirements for total and partial joint replacement implants, artificial ligaments and bone cement, hereafter referred to as implants. For the purposes of this International Standard, artificial ligaments and their associated fixing devices are included in the term "implant". It specifies requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information to be supplied by the manufacturer. Some tests required to demonstrate conformance to this International Standard are contained in or referenced in level 3 standards.
ÖNORM EN ISO 21534
2009 08 01
Non-active surgical implants - Joint replacement implants - Particular requirements (ISO 21534:2007)...
Norm
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ÖNORM EN ISO 21534
2008 01 01
Non-active surgical implants - Joint replacement implants - Particular requirements (ISO 21534:2007)...
Norm
ÖNORM EN 12010
1998 09 01
Non-active surgical implants - Joint replacement implants - Particular requirements
Norm
Norm
ISO 21534:2007
Issue date :
2007 09 26
Non-active surgical implants — Joint replacement implants — Particular requirements
Norm
ISO 4287:1997
Issue date :
1997 04 03
Geometrical Product Specifications (GPS) — Surface texture: Profile method — Terms, definitions and surface texture parameters
Norm
ISO 7206-4:2002
Issue date :
2002 10 25
Implants for surgery — Partial and total hip joint prostheses — Part 4: Determination of endurance properties of stemmed femoral components
Draft
ISO/DIS 7206-4
Issue date :
2008 12 23
Implants for surgery — Partial and total hip joint prostheses — Part 4: Determination of endurance properties and performance of stemmed femoral components
Norm
ISO 7206-8:1995
Issue date :
1995 04 06
Implants for surgery — Partial and total hip joint prostheses — Part 8: Endurance performance of stemmed femoral components with application of torsion
Norm
ISO 14155-1:2003
Issue date :
2003 02 26
Clinical investigation of medical devices for human subjects — Part 1: General requirements
Norm
ISO 14242-1:2002
Issue date :
2002 03 07
Implants for surgery — Wear of total hip-joint prostheses — Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for test
Norm
ISO 14242-2:2000
Issue date :
2000 10 05
Implants for surgery — Wear of total hip-joint prostheses — Part 2: Methods of measurement
Norm
ISO 14243-2:2000
Issue date :
2000 10 26
Implants for surgery — Wear of total knee-joint prostheses — Part 2: Methods of measurement
Draft
ISO/DIS 14243-2
Issue date :
2008 11 03
Implants for surgery — Wear of total knee-joint prostheses — Part 2: Methods of measurement
Norm
ISO 4287:1997
Issue date :
1997 04 03
Geometrical Product Specifications (GPS) — Surface texture: Profile method — Terms, definitions and surface texture parameters
Norm
ISO 7206-4:2010
Issue date :
2010 06 01
Implants for surgery — Partial and total hip joint prostheses — Part 4: Determination of endurance properties and performance of stemmed femoral components
Norm
ISO 7206-8:1995
Issue date :
1995 04 06
Implants for surgery — Partial and total hip joint prostheses — Part 8: Endurance performance of stemmed femoral components with application of torsion
Norm
ISO 14155-1:2003
Issue date :
2003 02 26
Clinical investigation of medical devices for human subjects — Part 1: General requirements
Norm
ISO 14242-1:2014
Issue date :
2014 10 16
Implants for surgery — Wear of total hip-joint prostheses — Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for test
Norm
ISO 14242-2:2016
Issue date :
2016 09 14
Implants for surgery — Wear of total hip-joint prostheses — Part 2: Methods of measurement
Norm
ISO 14243-2:2016
Issue date :
2016 09 05
Implants for surgery — Wear of total knee-joint prostheses — Part 2: Methods of measurement
Norm
ISO 14879-1:2000
Issue date :
2000 05 18
Implants for surgery — Total knee-joint prostheses — Part 1: Determination of endurance properties of knee tibial trays