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ILNAS-EN ISO 14630:2012 Edition 12/2012
Non-active surgical implants - General requirements (ISO 14630:2012)
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  • 25.3 / copy
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Abstract

ISO 14630:2012 specifies general requirements for non-active surgical implants. ISO 14630:2012 is not applicable to dental implants, dental restorative materials, transendodontic and transradicular implants, intra-ocular lenses and implants utilizing viable animal tissue. With regard to safety, ISO 14630:2012 specifies requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer, and tests to demonstrate compliance with these requirements.

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    20/01/2011   date of ratification (dor)    30/11/2012
end of the vote on the project    20/06/2011   date of anouncement (doa)    31/03/2013
start of the vote on the final project    09/08/2012   date of publication (dop)    30/06/2013
end of the vote on the final project    09/11/2012   date of withdrawal (dow)    30/06/2013


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

Relations

Evolutions
FprEN ISO 14630

Relations to older standards
ILNAS-EN ISO 14630:2009

Relations to international standards
ISO 14630 
ISO 14630:2012 
ISO 14630:2012 

International Classification for Standards (ICS codes) :

11.040.40 : Implants for surgery, prosthetics and orthotics

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