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EVS-EN ISO 21535:2009

Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants

General information

Valid from 06.11.2009
Base Documents
ISO 21535:2007; EN ISO 21535:2009
Directives or regulations
93/42/EEC Medical devices (MDD)

Standard history

Status
Date
Type
Name
Main
prEN ISO 21535
03.01.2017
Amendment
06.11.2009
Main
This International Standard provides specific requirements for hip joint replacement implants. With regard to safety, the standard gives requirements for intended performance, design attributes, materials, designe valuation, manufacture, sterilization, packaging and information supplied by the manufacturer, and methods of test.

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