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DIN
DIN EN ISO 21534 E : 2009

DIN EN ISO 21534 E : 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

01-01-2009

Publisher

German Institute for Standardisation (Deutsches Institut für Normung)

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
National Annex NA (informative) - Bibliography

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

DevelopmentNote
Supersedes DIN EN 12010 E. (01/2008)
DocumentType
Standard
Pages
22
PublisherName
German Institute for Standardisation (Deutsches Institut für Normung)
Status
Current
Supersedes

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

DIN EN ISO 21536 E : 2014 NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - SPECIFIC REQUIREMENTS FOR KNEE JOINT REPLACEMENT IMPLANTS (ISO 21536:2007 + AMD.1:2014)
DIN EN ISO 21535:2017-04 NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - SPECIFIC REQUIREMENTS FOR HIP-JOINT REPLACEMENT IMPLANTS (ISO 21535:2007 + AMD 1:2016)
DIN EN ISO 21535 E : 2017 NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - SPECIFIC REQUIREMENTS FOR HIP-JOINT REPLACEMENT IMPLANTS (ISO 21535:2007 + AMD 1:2016)

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
NFS 94 167-4 : 1998 IMPLANTS FOR SURGERY - ARTIFICIAL LIGAMENTS - PART 4: CHEMICAL CHARACTERIZATION - IDENTIFICATION OF TEXTILE MATERIALS (METHOD A) AND DETERMINATION OF EXTRACTABLE HEAVY METAL CONTENT (METHOD B)
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
DIN EN ISO 14155-1 E : 2003 CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - PART 1: GENERAL REQUIREMENTS
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)
NFS 94 167-2 : 2014 IMPLANTS FOR SURGERY - ARTIFICIAL LIGAMENTS - PART 2: MECHANICAL CHARACTERIZATION - DETERMINATION OF DIRECT TENSILE STRENGTH AND ELONGATION (METHOD A), DETERMINATION OF INDIRECT TENSILE STRENGTH AND ELONGATION (METHOD B) AND RESIDUAL ELONGATION (METHOD C)
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
NFS 94 167-6 : 1998 IMPLANTS FOR SURGERY - ARTIFICIAL LIGAMENTS - PART 6: CHARACTERIZATION OF DIMENSIONS
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
NFS 94 167-3 : 1998 IMPLANTS FOR SURGERY - ARTIFICIAL LIGAMENTS - PART 3: FATIGUE TEST - DETERMINATION OF RESISTANCE TO ABRASION (METHOD A) AND DETERMINATION OF RESISTANCE TO TORSION (METHOD B)
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
NFS 94 167-5 : 1998 IMPLANTS FOR SURGERY - ARTIFICIAL LIGAMENTS - PART 5: CHARACTERIZATION OF CLEANNESS - VERIFICATION OF EXTRACTABLE RESIDUES
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
NFS 94 167-1 : 1998 IMPLANTS FOR SURGERY - ARTIFICIAL LIGAMENTS - PART 1: GENERAL
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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