UNI EN ISO 21534 : 2009
Current
The latest, up-to-date edition.
NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - PARTICULAR REQUIREMENTS
08-11-2011
PREMESSA
INTRODUZIONE
1 SCOPO E CAMPO DI APPLICAZIONE
2 RIFERIMENTI NORMATIVI
3 TERMINI E DEFINIZIONI
4 PRESTAZIONI PREVISTE
5 ATTRIBUTI DEL PROGETTO
6 MATERIALI
7 VALUTAZIONE DEL PROGETTO
8 FABBRICAZIONE E CONTROLLO
9 STERILIZZAZIONE
10 IMBALLAGGIO
11 INFORMAZIONI FORNITE DAL FABBRICANTE
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
ANNEX ZA (informative) - RELATIONSHIP BETWEEN THIS EUROPEAN
STANDARD AND THE ESSENTIAL REQUIREMENTS OF
EU DIRECTIVE 93/42/EEC
BIBLIOGRAPHY
Describes particular requirements for total and partial joint replacement implants, artificial ligaments and bone cement, hereafter referred to as implants.
| Committee |
CT 44
|
| DevelopmentNote |
Supersedes UNI EN 12010. (04/2008) Bilingual (Italian + English) version issued in November 2011. (11/2011)
|
| DocumentType |
Standard
|
| PublisherName |
Ente Nazionale Italiano di Unificazione (UNI)
|
| 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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