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SSH EN ISO 21536:2009

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

Dec 22, 2009

General information

60.60     Dec 22, 2009

DPS

DPS/KT 205

European Norm

11.040.40  

English  

Buying

Published

Language in which you want to receive the document.

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 directives

Directives related to this standards.

93/42/EEC

Medical devices

Harmonized
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WITHDRAWN
SSH EN 12564:2000

NOW

PUBLISHED
SSH EN ISO 21536:2009
60.60 Standard published
Dec 22, 2009

REVISED BY

IN_DEVELOPMENT
prSSH EN ISO 21536:2024

Related project

Adopted from EN ISO 21536:2009