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EN ISO 21534:2009 Standard

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  Keywords:

#international #standard #design #specifies #implants

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

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

  Purpose

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

  Publication

Friday 17th of November 2017

  Reference

This standard supersedes the "EN ISO 21534:2007"

Anyway is still possible use the "EN ISO 21534:2007" until March 21st, 2010

  Related Standards

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