SS-EN-ISO-21536-AM1 › Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants - Amendment 1 (ISO 21536:2007/Amd 1:2014)
SS-EN-ISO-21536-AM1
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2009 EDITION AMENDMENT 1
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CURRENT
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This International Standard 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.
To find similar documents by classification:
Medical devices. 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
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Designation Name
SS-EN ISO 21536:2009/A1:2014
Revision Level
2009 EDITION AMENDMENT 1
Status
Current
Publication Date
March 9, 2014
Language(s)
English
Page Count
8
International Equivalent
EN ISO 21536:2009/A1:2014(IDT); ISO 21536:2007/Amd 1:2014(IDT)