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.
Dates of withdrawal of national standards are available from NSAI.
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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.
| DocumentType |
Standard
|
| Pages |
29
|
| PublisherName |
National Standards Authority of Ireland
|
| 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 |
| 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 |
| ISO 14602:2010 | Identical |
| NF EN ISO 14602 : 2012 | Identical |
| SN EN ISO 14602:2012 | Identical |
| ISO 14630:2012 | Non-active surgical implants — General requirements |
| ISO/TR 14283:2004 | Implants for surgery Fundamental principles |
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