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BS EN ISO 21534:2009

Current
Current

The latest, up-to-date edition.

Non-active surgical implants. Joint replacement implants. Particular requirements
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

31-10-2009

Publisher

British Standards Institution

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Intended performance
5 Design attributes
6 Materials
7 Design evaluation
8 Manufacture and inspection
9 Sterilization
10 Packaging
11 Information supplied by the manufacturer
Annex A (informative) - List of International Standards for
                        materials found acceptable for the
                        manufacture of implants
Annex B (informative) - List of International Standards for
                        materials found acceptable or not
                        acceptable for articulating surfaces
                        of implants
Annex C (informative) - List of materials found acceptable
                        or non-acceptable for metallic
                        combinations for non-articulating
                        contacting surfaces of implants
Bibliography
Annex ZA (informative) - Relationship between this European
                         Standard and the Essential Requirements
                         of EU Directive 93/42/EEC

Describes particular requirements for total and partial joint replacement implants, artificial ligaments and bone cement, hereafter referred to as implants.

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.

Committee
CH/150/4
DevelopmentNote
Supersedes 06/30094541 DC and BS EN 12010. (09/2008)
DocumentType
Standard
Pages
24
PublisherName
British Standards Institution
Status
Current
Supersedes

Standards Relationship
ISO 21534:2007 Identical
EN ISO 21534:2009 Identical

BS 6324-3:1983 Terms relating to surgical implants Glossary of terms relating to materials
BS 6324-2:1983 Terms relating to surgical implants Glossary of terms relating to mechanics
ISO 4287:1997 Geometrical Product Specifications (GPS) — Surface texture: Profile method — Terms, definitions and surface texture parameters
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
ASTM F 1357 : 2014 : REDLINE Standard Specification for Articulating Total Wrist Implants
BS 6324-5:1990 Terms relating to surgical implants Guidance on the usage of the terms \'valgus\' and \'varus\' in orthopaedic surgery
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 14155-1:2003 Clinical investigation of medical devices for human subjects Part 1: General requirements
ISO 14242-2:2016 Implants for surgery — Wear of total hip-joint prostheses — Part 2: Methods of measurement
ASTM F 370 : 1994 : R1999 Standard Specification for Proximal Femoral Endoprosthesis (Withdrawn 2005)
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/TR 9326:1989 Implants for surgery Partial and total hip joint prostheses Guidance for laboratory evaluation of change of form of bearing surfaces
ISO/TR 9325:1989 Implants for surgery Partial and total hip joint prostheses Recommendations for simulators for evaluation of hip joint prostheses
ISO 14630:2012 Non-active surgical implants General requirements
ISO 9584:1993 Implants for surgery — Non-destructive testing — Radiographic examination of cast metallic surgical implants
ISO 7207-2:2011 Implants for surgery — Components for partial and total knee joint prostheses — Part 2: Articulating surfaces made of metal, ceramic and plastics materials
BS 6324-1:1983 Terms relating to surgical implants Glossary of general medical terms
ISO 9583:1993 Implants for surgery — Non-destructive testing — Liquid penetrant inspection of metallic surgical implants
ASTM F 1223 : 2014 : REDLINE Standard Test Method for Determination of Total Knee Replacement Constraint
ISO 14879-1:2000 Implants for surgery Total knee-joint prostheses Part 1: Determination of endurance properties of knee tibial trays
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 8828:2014 Implants for surgery Guidance on care and handling of orthopaedic implants
ISO 7207-1:2007 Implants for surgery Components for partial and total knee joint prostheses Part 1: Classification, definitions and designation of dimensions
ISO 14243-3:2014 Implants for surgery Wear of total knee-joint prostheses Part 3: Loading and displacement parameters for wear-testing machines with displacement control and corresponding environmental conditions for test
ISO 7206-1:2008 Implants for surgery — Partial and total hip joint prostheses — Part 1: Classification and designation of dimensions
ISO 14243-1:2009 Implants for surgery Wear of total knee-joint prostheses Part 1: Loading and displacement parameters for wear-testing machines with load control and corresponding environmental conditions for test
ASTM F 604 : 1994 Specification for Silicone Elastomers Used in Medical Applications (Withdrawn 2001)
ISO 14243-2:2016 Implants for surgery — Wear of total knee-joint prostheses — Part 2: Methods of measurement
BS 6324-4:1983 Terms relating to surgical implants Glossary of orthopaedic surgical terms
NFS 94 065 : 1998 MATERIALS FOR SURGICAL IMPLANTS - DETERMINATION OF ARSENIC, MERCURY, CADMIUM AND LEAD ON COATINGS BASED ON PHOSPHATE OF CALCIUM

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Hardcopy - English
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