NF EN ISO 10993-12

NF EN ISO 10993-12

April 2005
Standard Cancelled

Biological evaluation of medical devices - Part 12 : Sample preparation and reference materials

ISO 10993-12:2002 specifies requirements and gives guidance on the procedures to be followed in the preparation of samples and the selection of reference materials for medical devices testing in biological systems in accordance with one or more parts of the ISO 10993 series. Specifically, ISO 10993-12:2002 addresses:test material selection;selection of representative portions from a device;test sample preparation;experimental controls;selection of and requirements for reference materials; and,preparation of extracts.The applicability of ISO 10993-12:2002 to absorbable materials, materials that polymerize in situ, tissue-engineered medical products and materials of biological origin should be carefully evaluated.

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Main informations

Collections

National standards and national normative documents

Publication date

April 2005

Number of pages

26 p.

Reference

NF EN ISO 10993-12

ICS Codes

11.040.01   Medical equipment in general
11.100.20   Biological evaluation of medical devices

Classification index

S99-512

Print number

1 - 17/03/2005

International kinship

ISO 10993-12:2002

European kinship

EN ISO 10993-12:2004
Sumary
Biological evaluation of medical devices - Part 12 : Sample preparation and reference materials

ISO 10993-12:2002 specifies requirements and gives guidance on the procedures to be followed in the preparation of samples and the selection of reference materials for medical devices testing in biological systems in accordance with one or more parts of the ISO 10993 series.

Specifically, ISO 10993-12:2002 addresses:

  • test material selection;
  • selection of representative portions from a device;
  • test sample preparation;
  • experimental controls;
  • selection of and requirements for reference materials; and,
  • preparation of extracts.

The applicability of ISO 10993-12:2002 to absorbable materials, materials that polymerize in situ, tissue-engineered medical products and materials of biological origin should be carefully evaluated.

Replaced standards (1)
NF EN ISO 10993-12
February 1997
Standard Cancelled
Plastics. Phenolic resins. Definitions and test methods.

Table of contents
  • Avant-propos
    iv
  • Introduction
    vi
  • 1
    Domaine d'application 1
  • 2
    Références normatives 1
  • 3
    Termes et définitions 1
  • 4
    Contrôles expérimentaux 3
  • 5
    Matériaux de référence 4
  • 5.1 Généralités
    4
  • 5.2
    Certification des matériaux de référence pour les essais de sécurité biologique 4
  • 6
    Utilisation des matériaux de référence comme contrôles expérimentaux 4
  • 7
    Choix du matériau d'essai 5
  • 8
    Préparation des échantillons et des matériaux de référence 5
  • 9
    Choix des parties représentatives d'un dispositif 5
  • 10
    Préparation d'extraits de matériaux d'essai 6
  • 10.1 Généralités
    6
  • 10.2
    Récipients utilisés pour l'extraction 6
  • 10.3
    Conditions et méthodes d'extraction 6
  • 10.4
    Conditions d'extraction pour l'identification et l'estimation des risques dans des conditions d'utilisation exagérées 8
  • 11 Rapport d'essai
    9
  • Annexe A (informative) Contrôles expérimentaux
    10
  • Annexe B (informative) Principes généraux et informations pratiques sur la préparation des matériaux d'essai et sur le choix des échantillons
    12
  • Annexe C (informative) Principes d'extraction de l'échantillon
    14
  • Bibliographie
    16
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