NF EN ISO 10993-12
NF EN ISO 10993-12

NF EN ISO 10993-12

September 2012
Standard Cancelled

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

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: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 10993-12:2012 is not applicable to live cells, but can be relevant to the material or device components of combination products containing live cells.

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Main informations

Collections

National standards and national normative documents

Publication date

September 2012

Number of pages

32 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 - août 2012

International kinship

ISO 10993-12:2012

European kinship

EN ISO 10993-12:2012
Sumary
Biological evaluation of medical devices - Part 12 : sample preparation and reference materials

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:

  • 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 10993-12:2012 is not applicable to live cells, but can be relevant to the material or device components of combination products containing live cells.

Replaced standards (1)
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.

Standard replaced by (1)
NF EN ISO 10993-12
NF EN ISO 10993-12
August 2021
Standard Current
Biological evaluation of medical devices — Part 12: Sample preparation and reference materials

Le présent document spécifie les exigences et fournit des recommandations sur les modes opératoires à suivre pour la préparation des échantillons et le choix des matériaux de référence dans le cadre d''essais relatifs aux dispositifs médicaux, dans la mesure où ils sont mis en oeuvre dans des systèmes d''essai biologique, conformément à une ou à plusieurs parties de l''ISO 10993. Le présent document traite plus spécifiquement des points suivants : le choix des échantillons ; le choix des parties représentatives d''un dispositif médical ; la préparation des échantillons ; les témoins expérimentaux ; le choix des matériaux de référence et les exigences qui s''y rapportent ; la préparation des extraits. Le présent document n''est pas applicable aux cellules vivantes, mais il peut s''appliquer aux matériaux ou aux composants de dispositifs médicaux de produits combinés contenant des cellules vivantes.

Table of contents
  • 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 (MR)
    4
  • 5.1 Généralités
    4
  • 5.2 Certification des MR pour les essais de sécurité biologique
    4
  • 6 Utilisation des MR comme témoins expérimentaux
    4
  • 7 Choix des échantillons
    5
  • 8 Préparation des échantillons et des MR
    5
  • 9 Choix des parties représentatives d'un dispositif
    6
  • 10 Préparation d'extraits d'échantillons
    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 des phénomènes dangereux et l'estimation des risques dans des conditions d'utilisation exagérées (points à prendre en compte en relation avec l'Annexe D)
    9
  • 11 Rapport d'essai
    10
  • Annexe A (informative) Témoins 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
  • Annexe D (informative) Extraction exhaustive des matériaux polymériques pour l'évaluation biologique
    18
  • Bibliographie
    21
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