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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Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Non-active surgical implants — Joint replacement implants — Specific requirements for hip-joint replacement implants

Available format(s)

Hardcopy , PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users

Superseded date

05-07-2023

Published date

26-09-2007

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Superseded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

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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