Non-active surgical implants. Implants for osteosynthesis. Particular requirements

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

10-31-2011

Publisher

British Standards Institution

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	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	BS EN ISO 14602:2010 95/561932 DC : AUG 95

Standards	Relationship
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
I.S. EN ISO 14602:2011	Identical
SN 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