NF EN ISO 10993-12

NF EN ISO 10993-12

June 2021
Standard Current

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

This document specifies requirements and gives guidance on the procedures in the preparation of samples and the selection of reference materials for medical device testing primarily in biological test systems primarily in accordance with one or more parts of the ISO 10993 series.Specifically, this document addresses the following:— test sample selection;— selection of representative portions from a medical device;— test sample preparation;— experimental controls;— selection of, and requirements for, reference materials;— preparation of extracts.This document is not applicable to live cells but can be relevant to the material or medical device components of combination products containing live cells.Extractions for chemical characterization are covered in ISO 10993-18. Clause 7, 8, 9, 10 [with the exception of 10.3.5 and 10.3.11 b)], and 11 can apply to extractions for chemical characterization. Information given in C.1 to C.4 can also be relevant.

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Main informations

Collections

National standards and national normative documents

Publication date

June 2021

Number of pages

33 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

International kinship

ISO 10993-12:2021

European kinship

EN ISO 10993-12:2021
Sumary
Biological evaluation of medical devices - Part 12 : sample preparation and reference materials

This document specifies requirements and gives guidance on the procedures in the preparation of samples and the selection of reference materials for medical device testing primarily in biological test systems primarily in accordance with one or more parts of the ISO 10993 series.

Specifically, this document addresses the following:

— test sample selection;

— selection of representative portions from a medical device;

— test sample preparation;

— experimental controls;

— selection of, and requirements for, reference materials;

— preparation of extracts.

This document is not applicable to live cells but can be relevant to the material or medical device components of combination products containing live cells.

Extractions for chemical characterization are covered in ISO 10993-18. Clause 7, 8, 9, 10 [with the exception of 10.3.5 and 10.3.11 b)], and 11 can apply to extractions for chemical characterization. Information given in C.1 to C.4 can also be relevant.

Replaced standards (1)
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.

Table of contents
  • Avant-propos
  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes et définitions
  • 4 Exigences générales
  • 5 Matériaux de référence (MR)
  • 6 Utilisation des MR comme témoins expérimentaux
  • 7 Choix des échantillons
  • 8 Préparation des échantillons et des MR
  • 9 Choix des parties représentatives d'un dispositif médical
  • 10 Préparation d'extraits d'échantillons
  • 11 Rapport d'essai
  • Annexe A (informative) Témoins expérimentaux
  • Annexe B (informative) Principes généraux et informations pratiques sur la préparation et le choix des échantillons
  • Annexe C (informative) Principes d'extraction de l'échantillon
  • Annexe D (informative) Extraction exhaustive des matériaux polymères pour l'évaluation biologique
  • Annexe ZA (informative) Relation entre la présente Norme européenne et les exigences générales en matière de sécurité et de performances concernées du Règlement (UE) 2017/745
  • Bibliographie
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