SS-EN-ISO-21535-AM1 Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants - Amendment 1 (ISO 21535:2007/Amd 1:2016)

SS-EN-ISO-21535-AM1 - 2009 EDITION AMENDMENT 1 - CURRENT


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This International Standard 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.

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 21535:2009/A1:2016

Revision Level

2009 EDITION AMENDMENT 1

Status

Current

Publication Date

Dec. 16, 2016

Language(s)

English

Page Count

20

International Equivalent

EN ISO 21535:2009/A1:2016(IDT); ISO 21535:2007/Amd 1:2016(IDT)