NF EN ISO 10993-12

NF EN ISO 10993-12

December 2009
Standard Cancelled

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

ISO 10993-12:2007 specifies requirements and gives guidance on the procedures to be followed in the preparation of samples and the selection of reference materials for medical device testing in biological systems in accordance with one or more parts of the ISO 10993 series. Specifically ISO 10993-12:2007 addresses: test sample selection;selection of representative portions from a device;test sample preparation;experimental controls;selection of and requirements for reference materials;preparation of extracts. ISO 10993-12:2007 is not applicable to materials or devices containing live cells.

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Main informations

Collections

National standards and national normative documents

Publication date

December 2009

Number of pages

28 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

S99-501-12

Print number

1 - 16/12/2009

International kinship

ISO 10993-12:2007

European kinship

EN ISO 10993-12:2009
Sumary
Biological evaluation of medical devices - Part 12 : sample preparation and reference materials

ISO 10993-12:2007 specifies requirements and gives guidance on the procedures to be followed in the preparation of samples and the selection of reference materials for medical device testing in biological systems in accordance with one or more parts of the ISO 10993 series. Specifically ISO 10993-12:2007 addresses:

  1. test sample selection;
  2. selection of representative portions from a device;
  3. test sample preparation;
  4. experimental controls;
  5. selection of and requirements for reference materials;
  6. preparation of extracts.

ISO 10993-12:2007 is not applicable to materials or devices containing live cells.

Standard replaced by (1)
NF EN ISO 10993-12
September 2012
Standard Cancelled
Biological evaluation of medical devices - Part 12 : sample preparation and reference materials

<p>ISO 10993-12:2012 specifies requirements and gives guidance on the procedures to be followed in the preparation of samples and the selection of reference materials for medical device testing in biological systems in accordance with one or more parts of ISO 10993. Specifically, ISO 10993-12:2012 addresses the following:</p> <ul> <li>test sample selection;</li> <li>selection of representative portions from a device;</li> <li>test sample preparation;</li> <li>experimental controls;</li> <li>selection of, and requirements for, reference materials;</li> <li>preparation of extracts.</li> </ul> <p>ISO 10993-12:2012 is not applicable to live cells, but can be relevant to the material or device components of combination products containing live cells.</p>

Table of contents
View the extract
  • Avant-propos
    iv
  • Introduction
    vi
  • 1 Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Termes et définitions
    1
  • 4 Exigences générales
    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
    5
  • 7 Choix des échantillons
    5
  • 8 Préparation des échantillons et des matériaux de référence
    5
  • 9 Choix des parties représentatives d'un dispositif
    6
  • 10 Préparation d'extraits d'échantillons d'essai
    6
  • 10.1 Généralités
    6
  • 10.2 Récipients utilisés pour l'extraction
    6
  • 10.3 Conditions et méthodes d'extraction
    7
  • 10.4 Conditions d'extraction pour l'identification et l'estimation des risques dans des conditions d'utilisation exagérées
    9
  • 11 Rapport d'essai
    10
  • Annexe A (informative) Contrôles expérimentaux
    11
  • Annexe B (informative) Principes généraux et informations pratiques sur la préparation et le choix des échantillons
    13
  • Annexe C (informative) Principes d'extraction de l'échantillon
    15
  • Bibliographie
    18
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