BAS EN ISO 21535:2010
Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants
General Information
Status: Published
No. of pages: 14
Language: English
Edition: 2.
Adoption method: Endorsment
Publication date: 25.06.2010
Technical committee:
Directive:
93/42/EEC, Medical devices
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Abstract
ISO 21535:2007 provides specific requirements for hip 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.
Lifecycle
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Original document and degree of correspondence
- EN ISO 21535:2009, identical
- ISO 21535:2007, identical