UNI EN ISO 14602 : 2012
Current
The latest, up-to-date edition.
NON-ACTIVE SURGICAL IMPLANTS - IMPLANTS FOR OSTEOSYNTHESIS - PARTICULAR REQUIREMENTS
02-02-2012
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
Describes particular requirements for non-active surgical implants for osteosynthesis, hereafter referred to as implants.
Committee |
CT 44
|
DocumentType |
Standard
|
PublisherName |
Ente Nazionale Italiano di Unificazione (UNI)
|
Status |
Current
|
Supersedes |
Standards | Relationship |
BS EN ISO 14602:2011 | Identical |
NBN EN ISO 14602 : 2011 | Identical |
EN ISO 14602:2011 | Identical |
NEN EN ISO 14602 : 2012 | Identical |
NS EN ISO 14602 : 2011 | Identical |
UNE-EN ISO 14602:2012 | Identical |
ISO 14602:2010 | Identical |
NF EN ISO 14602 : 2012 | Identical |
I.S. EN ISO 14602:2011 | Identical |
SN EN ISO 14602:2012 | Identical |
DIN EN ISO 14602:2012-06 | Identical |
ISO 14630:2012 | Non-active surgical implants — General requirements |
ISO/TR 14283:2004 | Implants for surgery Fundamental principles |
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