Standard

NS-EN ISO 21534:2009

Aug 2009 Published

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Abstract

ISO 21534:2007 specifies particular requirements for total and partial joint replacement implants, artificial ligaments and bone cement, referred to as implants in the text. For the purposes of this International Standard, artificial ligaments and their associated fixing devices are included in the term "implant".ISO 21534:2007 specifies requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information to be supplied by the manufacturer.

Document information

Standard from SN
Published: 1 August 2009
Edition: 2009-05
Version: 1
Document type: NAT
ISBN:

ICS 11.040.40
National Committee CEN/TC 285

Legal references

EU law: 93/42/EEC, 2007/47/EC

Product Relations

Replaces: NS-EN ISO 21534:2007
Refers: ISO 7206-4:2002
Refers: ISO 7206-4:2002
Refers: ISO 14242-1:2002
Refers: ISO 14242-1:2002
Refers: ISO 14243-2:2000
Refers: ISO 14242-2:2000
Refers: ISO 14879-1:2000
Refers: ISO 7206-8:1995
Adopted from: EN ISO 21534:2009 , 0

Product life cycle

Previous product

Withdrawn

NS-EN ISO 21534:2007
Current product

Published

NS-EN ISO 21534:2009

NS-EN ISO 21534:2009

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