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ISO 21534:2007

Non-active surgical implants -- Joint replacement implants -- Particular requirements

General information

Valid from 26.09.2007
ICS Groups
11.040.40 Implants for surgery, prosthetics and orthotics
Directives or regulations
None

Standard history

Status
Date
Type
Name
26.09.2007
Main
ISO 21534:2007
Main
ISO 21534:2002
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.

Required fields are indicated with *

*
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PDF
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Paper
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Standard monitoring
English (PDF 145 KB)

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Standards designation

EVS Estonian standard
EN European standard (published by an CEN or CENELEC)
EN ISO International standard adopted as an European standard
ISO International Organization for Standardization’s standard
IEC International Electrotechnical Commission’s standard
HD CENELEC’s harmonisation document
   
EVS-EN European standard implemented in Estonia
EVS-EN ISO International standard adopted in Europe and implemented in Estonia
EVS-EN ISO/IEC International standard/International electrotechnical standard adopted in Europe and implemented in Estonia
EVS-IEC International electrotechnical standard implemented in Estonia
EVS-ISO International standard implemented in Estonia
   
A, AMD amedment
+A a full standard plus the amendment
/A only amendment
COR, AC corrigendum
+COR a full standard plus the corrigendum
NA national annex
+NA a full standard plus the national annex
/NA only national annex
TS technical specification
TR technical report
CWA agreement, developed by a CEN or CENELEC
prEVS-EN (etc) draft standard
   
et the standard is in Estonian only
en the standard is in English only
et-en the standard is in Parallel text Estonian-English