EN ISO 21536:2009

Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants (ISO 21536:2007) EN ISO 21536:2009

Publication date:   Aug 21, 2009

General information

60.60 Standard published   May 6, 2009

CEN

CEN/TC 285 Non-active surgical implants

European Norm

11.040.40   Implants for surgery, prosthetics and orthotics

Buying

Published

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Scope

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.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

Harmonized/Supporting
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

Life cycle

PREVIOUSLY

WITHDRAWN
EN ISO 21536:2007

NOW

PUBLISHED
EN ISO 21536:2009
60.60 Standard published
May 6, 2009

CORRIGENDA / AMENDMENTS

PUBLISHED
EN ISO 21536:2009/A1:2014

REVISED BY

IN_DEVELOPMENT
FprEN ISO 21536

Relations

Adopted from ISO 21536:2007 IDENTICAL