EN ISO 14602:2011
Current
The latest, up-to-date edition.
Non-active surgical implants - Implants for osteosynthesis - Particular requirements (ISO 14602:2010)
19-10-2011
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Intended performance
5 Design attributes
6 Materials
7 Design evaluation
8 Manufacturing
9 Sterilization
10 Packaging
11 Information supplied by manufacturer
Annex A (informative) - Correspondence of the clauses of
this International Standard to the fundamental
principles outlined in ISO/TR 14283
Annex B (informative) - ISO standards referring to implants
and associated instruments found acceptable through
clinical use for given applications in osteosynthesis
Annex C (informative) - ISO Standards referring to materials
found acceptable through proven clinical use
Annex D (informative) - Standards related to testing and
design evaluation
Bibliography
Annex ZA (informative) - Relationship between this European
Standard and the Essential Requirements of EU
Directive 93/42/EEC
ISO 14602:2010 specifies particular requirements for non-active surgical Implants for osteosynthesis, referred to as implants.In addition to ISO 14630, ISO 14602:2010 gives particular requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer.
| Committee |
CEN/TC 285
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Current
|
| Standards | Relationship |
| SS-EN ISO 14602 : 2011 | Identical |
| BS EN ISO 14602:2011 | Identical |
| NBN EN ISO 14602 : 2011 | Identical |
| NEN EN ISO 14602 : 2012 | Identical |
| UNI EN ISO 14602 : 2012 | Identical |
| NS EN ISO 14602 : 2011 | Identical |
| UNE-EN ISO 14602:2012 | Identical |
| DIN EN ISO 14602:2012-06 | Identical |
| PN EN ISO 14602 : 2011 | Identical |
| ISO 14602:2010 | Identical |
| NF EN ISO 14602 : 2012 | Identical |
| I.S. EN ISO 14602:2011 | Identical |
| SN EN ISO 14602:2012 | Identical |
| EN 12011 : 1998 | INSTRUMENTATION TO BE USED IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS |
| I.S. EN 12011:1998 | INSTRUMENTATION TO BE USED IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS |
| BS EN 12011:1998 | Instrumentation to be used in association with non-active surgical implants. General requirements |
| 2007/47/EC : 2007 COR 1 2015 | DIRECTIVE 2007/47/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 5 SEPTEMBER 2007 AMENDING COUNCIL DIRECTIVE 1990/385/EEC ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES RELATING TO ACTIVE IMPLANTABLE MEDICAL DEVICES, COUNCIL DIRECTIVE 1993/42/EEC CONCERNING MEDICAL DEVICES AND DIRECTIVE 1998/8/EC CONCERNING THE PLACING OF BIOCIDAL PRODUCTS ON THE MARKET(TEXT WITH EEA RELEVANCE) |
| ISO 14630:2012 | Non-active surgical implants — General requirements |
| ISO/TR 14283:2004 | Implants for surgery Fundamental principles |
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