Standard

NS-EN ISO 22803:2005

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Corrigenda and amendments are bought separately.

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Abstract

ISO 22803:2004 gives the requirements for a technical file on the evaluation of the chemical, physical, mechanical, biological and clinical aspects and behaviour of membrane materials, whether resorbable, partially resorbable or non-resorbable, which are used a) for guided tissue regeneration in oral and maxillofacial surgery to correct a morphological defect or abnormality, b) in contact with teeth and/or dental implants, c) for prevention of epithelial migration in periodontal surgery, d) for the augmentation of bone prior to the planned insertion of dental implants, e) and/or for augmentation of bone for stabilization of dental prostheses. This International Standard is not applicable to materials whose primary intended use is to deliver a medicinal product, autografts and allografts, or materials intended to act through pharmacological, immunological or metabolic means.

Document information

  • Standard from SN
  • Published:
  • Edition: 2005-11
  • Version: 1
  • Document type: NAT
  • ICS 11.060.15
  • National Committee SN/K 109

Product Relations

  • Adopted from: EN ISO 22803:2005 , 0