Standard

NS-EN ISO 21534:2007

Withdrawn

Note: This standard has a new edition: NS-EN ISO 21534:2009

Corrigendums and amendments are bought separately.

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Abstract

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.

Document information

  • Standard from SN
  • Published:
  • Withdrawn:
  • Edition: 1
  • Version: 1
  • Document type: NAT
  • ICS 11.040.40
  • National Committee CEN/TC 285

Legal references

EU law: 93/42/EEC

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