Standard

SN EN ISO 21535:2009

Oct 2009 Current

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Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants (ISO 21535:2007/Amd 1:2016); Amendment A1 Current SN EN ISO 21535/A1:2017 Amendment from Publication date: Feb 2017 Version: Pages: 3 Language: English, French, German Services: Online, Online + Pdf

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.

Products specifications

Standard from INB
Published: October 1 2009
Effective: October 1 2009
Document type: EN
Pages
ISBN:

ICS: 11.040.40
Publisher: SNV
Distributor: SNV
National Committee: INB/NK 129

Swiss Federal Authority: SWISSMEDIC
Designated under following Swiss law: 812.213
Designated under following EU law: 93/42/EWG

Product Relations

Replaces: SN EN ISO 21535:2007
Adopted from: ISO 21535:2007, IDT

Extended editions Extended editions (0)

Version history Related Corrigenda and Amendments (1)

SN EN ISO 21535/A1:2017

Version history History (2)