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ILNAS-EN ISO 14602:2011 Edition 10/2011
Non-active surgical implants - Implants for osteosynthesis - Particular requirements (ISO 14602:2010)
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  • 25.3 / copy
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Abstract

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.

Status

Standard - Active

Origin

Technical Committee :
CEN/TC 285 : Non-active surgical implants

Directives

93/42/EEC : Medical devices
2007/47/EC : Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market

Implementation

start of the vote on the project      date of ratification (dor)    20/09/2011
end of the vote on the project      date of anouncement (doa)    31/01/2012
start of the vote on the final project      date of publication (dop)    30/04/2012
end of the vote on the final project      date of withdrawal (dow)    30/04/2012


Publication Official Journal
of the Grand-Duchy of Luxembourg
05/06/2013
Reference Mémorial A N° 92

Relations

Relations to older standards
ILNAS-EN ISO 14602:2010

International Classification for Standards (ICS codes) :

11.040.40 : Implants for surgery, prosthetics and orthotics

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