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.

See more
View the extract
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 - 17/08/2012

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
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
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.

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
ZOOM ON ... the Requirements department
To comply with a standard, you need to quickly understand its issues in order to determine its impact on your activity.

The Requirements department helps you quickly locate within the normative text:
- mandatory clauses to satisfy,
- non-essential but useful clauses to know, such as permissions and recommendations.

The identification of these types of clauses is based on the document “ISO / IEC Directives, Part 2 - Principles and rules of structure and drafting of ISO documents ”as well as on a constantly enriched list of verbal forms.

With Requirements, quickly access the main part of the normative text!

With Requirements, quickly access the main part of the normative text!
What is the Redline format?
The Redline + service - standards comparator allows you to easily and simply identify major changes between the current standard and its last canceled version.

At a glance, you will be able to identify the additions, deletions or modifications to a text, table, figure and formula.
At a glance, you will be able to identify the additions, deletions or modifications to a text, table, figure and formula

The Redlines + service is offered to you on the collection of French standards in force, in French language and in HTML and PDF format.

For an overview of the service, click on View a standard in redline format
Need to identify, monitor and decipher standards?

COBAZ is the simple and effective solution to meet the normative needs related to your activity, in France and abroad.

Available by subscription, CObaz is THE modular solution to compose according to your needs today and tomorrow. Quickly discover CObaz!

Request your free, no-obligation live demo

I discover COBAZ