SS-EN-ISO-21534 Non-active surgical implants - Joint replacement implants - Particular requirements (ISO 21534:2007)

SS-EN-ISO-21534 - 2009 EDITION - CURRENT
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This International Standard specifies particular requirements for total and partial joint replacement implants, artificial ligaments and bone cement, hereafter referred to as implants. For the purposes of this International Standard, artificial ligaments and their associated fixing devices are included in the term "implant". It specifies requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information to be supplied by the manufacturer. Some tests required to demonstrate conformance to this International Standard are contained in or referenced in level 3 standards.

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

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Designation Name

SS-EN ISO 21534:2009

Revision Level

2009 EDITION

Status

Current

Publication Date

May 25, 2009

Language(s)

English

Page Count

32

International Equivalent

EN ISO 21534:2009(IDT); ISO 21534:2007(IDT)