ISO 21535:2007
Superseded
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Non-active surgical implants — Joint replacement implants — Specific requirements for hip-joint replacement implants
Amended by
Available format(s)
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
Superseded date
07-05-2023
Superseded by
Published date
09-26-2007
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ISO 21535:2007 provides specific requirements for hip joint replacement implants. With regard to safety, this International Standard specifies requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging, information supplied by the manufacturer, and methods of test.
| Committee |
ISO/TC 150/SC 4
|
| DevelopmentNote |
Supersedes ISO/DIS 21535. (10/2007)
|
| DocumentType |
Standard
|
| Pages |
9
|
| PublisherName |
International Organization for Standardization
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| DIN EN ISO 21535:2017-04 | Identical |
| UNI EN ISO 21535:2017 | Identical |
| DIN EN ISO 21535:2009-08 | Identical |
| NF EN ISO 21535 : 2009 AMD 1 2017 | Identical |
| GOST R ISO 21535 : 2013 | Identical |
| NBN EN ISO 21535 : 2009 | Identical |
| NEN EN ISO 21535 : 2009 AMD 1 2016 | Identical |
| NS EN ISO 21535 : 2009 AMD 1 2016 | Identical |
| I.S. EN ISO 21535:2009 | Identical |
| PN EN ISO 21535 : 2009 AMD 1 2017 | Identical |
| SN EN ISO 21535 : 2009 AMD 1 2017 | Identical |
| UNI EN ISO 21535 : 2009 | Identical |
| NF EN ISO 21535 August 2009 | Identical |
| NEN-EN-ISO 21535 : 2009 | Identical |
| SS-EN ISO 21535 : 2009 | Identical |
| PN-EN ISO 21535 : 2019 | Identical |
| SN EN ISO 21535 : 2009 | Identical |
| UNE-EN ISO 21535:2009 | Identical |
| BS EN ISO 21535 : 2009 | Identical |
| ONORM EN ISO 21535 : 2017 | Identical |
| DS/EN ISO 21535 : 2009 | Identical |
| DS EN ISO 21535 : 2009 AMD 1 2016 | Identical |
| UNE-EN ISO 21535:2008 | Identical |
| DIN EN 12563:1999-02 | Corresponds |
| BS EN ISO 21535:2009+A1:2016 | Identical |
| 04/300654 DC : DRAFT JAN 2004 | BS EN ISO 14630 - NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS |
| ISO 16142-1:2016 | Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards |
| BS EN ISO 14630:2012 | Non-active surgical implants. General requirements |
| BS ISO 16142-1:2016 | Medical devices. Recognized essential principles of safety and performance of medical devices General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards |
| ISO 7206-1:2008 | Implants for surgery — Partial and total hip joint prostheses — Part 1: Classification and designation of dimensions |
| I.S. EN ISO 14630:2012 | NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS (ISO 14630:2012) |
| ASTM F 3018 : 2017 | Standard Guide for Assessment of Hard-on-Hard Articulation Total Hip Replacement and Hip Resurfacing Arthroplasty Devices |
| UNI EN ISO 14630 : 2013 | NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS |
| BS ISO 7206-1:2008 | Implants for surgery. Partial and total hip joint prostheses Classification and designation of dimensions |
| DIN EN ISO 14630:2013-03 | Non-active surgical implants - General requirements (ISO 14630:2012) |
| UNE-EN ISO 14630:2013 | Non-active surgical implants - General requirements (ISO 14630:2012) |
| EN ISO 14630:2012 | Non-active surgical implants - General requirements (ISO 14630:2012) |
| ASTM F 2582 : 2014 : REDLINE | Standard Test Method for Impingement of Acetabular Prostheses |
| ASTM F 2091 : 2015 : REDLINE | Standard Specification for Acetabular Prostheses |
| ISO 14630:2012 | Non-active surgical implants — General requirements |
| ISO 7206-10:2003 | Implants for surgery Partial and total hip-joint prostheses Part 10: Determination of resistance to static load of modular femoral heads |
| ISO 14242-1:2014 | 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 |
| 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 |
| ISO 21534:2007 | Non-active surgical implants Joint replacement implants Particular requirements |
| ISO 7206-4:2010 | Implants for surgery Partial and total hip joint prostheses Part 4: Determination of endurance properties and performance of stemmed femoral components |
| ISO 14242-3:2009 | Implants for surgery — Wear of total hip-joint prostheses — Part 3: Loading and displacement parameters for orbital bearing type wear testing machines and corresponding environmental conditions for test |
| ISO 14242-2:2016 | Implants for surgery — Wear of total hip-joint prostheses — Part 2: Methods of measurement |
| ISO 7206-6:2013 | Implants for surgery — Partial and total hip joint prostheses — Part 6: Endurance properties testing and performance requirements of neck region of stemmed femoral components |
| ISO 14630:2012 | Non-active surgical implants — General requirements |
| ASTM F 3047M : 2015 | Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-hard Articulations |
| ISO 7206-2:2011 | Implants for surgery — Partial and total hip joint prostheses — Part 2: Articulating surfaces made of metallic, ceramic and plastics materials |
| ISO 7206-1:2008 | Implants for surgery — Partial and total hip joint prostheses — Part 1: Classification and designation of dimensions |
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