Name: UNI EN ISO 21534 : 2009
Brand: UNI

NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - PARTICULAR REQUIREMENTS

Published date

08-11-2011

Publisher

Ente Nazionale Italiano di Unificazione (UNI)

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	UNI EN 12010 : 2000 UNI EN ISO 21534 : 2008

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