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ISO 10993-12 FRENCH

Évaluation biologique des dispositifs médicaux — Partie 12: Préparation des échantillons et matériaux de référence

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Organization: ISO
Publication Date: 1 January 2021
Status: active
Page Count: 30
ICS Code (Biological evaluation of medical devices): 11.100.20

Document History

ISO 10993-12 FRENCH
January 1, 2021
Évaluation biologique des dispositifs médicaux — Partie 12: Préparation des échantillons et matériaux de référence
A description is not available for this item.
ISO 10993-12 FRENCH
July 1, 2012
Évaluation biologique des dispositifs médicaux - Partie 12: Préparation des échantillons et matériaux de référence
A description is not available for this item.
ISO 10993-12 FRENCH
November 15, 2007
Évaluation biologique des dispositifs médicaux - Partie 12: Préparation des échantillons et matériaux de référence
A description is not available for this item.

References

This document references:
ISO GUIDE 33 - Reference materials - Good practice in using reference materials
Published by ISO on February 1, 2015
This Guide describes good practice in using reference materials (RMs), and certified reference materials (CRMs) in particular, in measurement processes. These uses include the assessment of precision...
This document references:
ISO 10993-1 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
Published by ISO on August 1, 2018
This document specifies: — the general principles governing the biological evaluation of medical devices within a risk management process; — the general categorization of medical devices based on the...
This document references:
ISO GUIDE 30 - Reference materials — Selected terms and definitions AMENDMENT 1: Revisions of definitions for reference material and certified reference material
Published by ISO on September 4, 2019
A description is not available for this item.
This document references:
ISO GUIDE 31 - Reference materials - Contents of certificates, labels and accompanying documentation
Published by ISO on November 1, 2015
This Guide is intended to help reference material (RM) producers in preparing clear and concise documentation to accompany an RM. It lists and explains mandatory, recommended and other categories of...
This document references:
ISO GUIDE 35 - Reference materials - Guidance for characterization and assessment of homogeneity and stability
Published by ISO on August 1, 2017
This document explains concepts and provides approaches to the following aspects of the production of reference materials: - the assessment of homogeneity; - the assessment of stability and the...
This document is referenced by:
ISO 10993-16 - Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
Published by ISO on May 1, 2017
This document provides principles on designing and performing toxicokinetic studies relevant to medical devices. Annex A describes the considerations for inclusion of toxicokinetic studies in the...
This document is referenced by:
ISO 29701 - Nanotechnologies — Endotoxin test on nanomaterial samples for in vitro systems — Limulus amebocyte lysate (LAL) test
Published by ISO on September 15, 2010
This International Standard describes the application of a test using Limulus amebocyte lysate (LAL) reagent for the evaluation of nanomaterials intended for cell-based in vitro biological test...
This document is referenced by:
BS EN ISO 10993-10 - Biological evaluation of medical devices Part 10: Tests for skin sensitization
Published by BSI on February 28, 2023
A description is not available for this item.
This document is referenced by:
BS EN ISO 7405 - Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
Published by BSI on November 30, 2018
A description is not available for this item.
This document is referenced by:
BS EN ISO 10993-4 - Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood
Published by BSI on May 31, 2017
A description is not available for this item.
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