I.S. EN ISO 14602:2011
Current
The latest, up-to-date edition.
NON-ACTIVE SURGICAL IMPLANTS - IMPLANTS FOR OSTEOSYNTHESIS - PARTICULAR REQUIREMENTS (ISO 14602:2010)
Hardcopy , PDF
English
01-01-2011
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
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
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