Standard

SN EN ISO 10993-12:1997

Radié

Note: Version actuelle: SN EN ISO 10993-12:2021

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Résumé

The document specifies requirements and gives guidance on procedures to be followed in the preparation of samples of medical devices for testing in biological systems in accordance with one or more other parts of ISO 10993. These include; a) test material selection; b) selection of representative portions from a device; c) test sample preparation; d) the selection of reference materials to demonstrate the suitability of the test systems and/or to enable relative comparison of the biological activity of the test sample; and e) preparation of extract.

Spécifications des produits

  • Standard de INB
  • Publié:
  • Radié:
  • Effectif:
  • Type de document: EN
  • Pages
  • ICS: 11.040.01
  • ICS: 11.060.01
  • ICS: 11.120.01
  • Editeur: SNV
  • Distributeur: SNV
  • Comité national: INB/NK 129

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