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ILNAS-EN ISO 21536:2009 Edition 05/2009
Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants (ISO 21536:2007)
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  • 17.8 / copy
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Abstract

ISO 21536:2007 provides specific requirements for knee joint replacement implants. With regard to safety, this International Standard specifies requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging, information supplied by the manufacturer and methods of test.

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)    12/04/2009
end of the vote on the project      date of anouncement (doa)    31/08/2009
start of the vote on the final project    11/12/2008   date of publication (dop)    30/11/2009
end of the vote on the final project    11/03/2009   date of withdrawal (dow)    21/03/2010


Publication Official Journal
of the Grand-Duchy of Luxembourg
14/03/2011
Reference Mémorial A N° 47

Relations

Evolutions
FprEN ISO 21536
ILNAS-EN ISO 21536:2009/A1:2014

Relations to older standards
ILNAS-EN ISO 21536:2007

International Classification for Standards (ICS codes) :

11.040.40 : Implants for surgery, prosthetics and orthotics

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