BS EN ISO 14602:2011
Current
The latest, up-to-date edition.
Non-active surgical implants. Implants for osteosynthesis. Particular requirements
Hardcopy , PDF
English
31-10-2011
| Committee |
CH/150/5
|
| DevelopmentNote |
Supersedes 95/561932 DC (08/2004) To be read in conjunction with BS EN ISO 14630. (02/2010) Supersedes 09/30198885 DC. (05/2010)
|
| DocumentType |
Standard
|
| Pages |
26
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
| Supersedes |
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.
| Standards | Relationship |
| NBN EN ISO 14602 : 2011 | Identical |
| EN ISO 14602:2011 | Identical |
| NEN EN ISO 14602 : 2012 | Identical |
| NS EN ISO 14602 : 2011 | Identical |
| DIN EN ISO 14602:2012-06 | Identical |
| ISO 14602:2010 | Identical |
| NF EN ISO 14602 : 2012 | Identical |
| I.S. EN ISO 14602:2011 | Identical |
| UNE-EN ISO 14602:2012 | Identical |
| 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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