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SRPS EN ISO 21536:2011

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

Sep 30, 2011
95.99   Withdrawal of Standard   Nov 29, 2024

General information

95.99     Nov 29, 2024

ISS

Z076

European Norm

11.040.40  

English  

From plan 2011

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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 directives

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.

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

NOW

WITHDRAWN
SRPS EN ISO 21536:2011
95.99 Withdrawal of Standard
Nov 29, 2024

REVISED BY

PUBLISHED
SRPS EN ISO 21536:2024

Related project

Adopted from EN ISO 21536:2009

Adopted from ISO 21536:2007 IDENTICAL