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 - 2009 EDITION AMENDMENT 1 - 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:

11.040.40 (Implants for surgery, prosthetics and orthotics Including pacemakers Ophthalmic implants, see 11.040.70)


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)