ISO-21534 › Non-active surgical implants - Joint replacement implants - Particular requirements

ISO-21534 - 2ND EDITION - CURRENT
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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.

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

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Document Number

ISO 21534:2007

Revision Level

2ND EDITION

Status

Current

Publication Date

Oct. 1, 2007

Committee Number

ISO/TC 150/SC 4