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ISO 10993-12:2021

Biological evaluation of medical devices — Part 12: Sample preparation and reference materials

Edition date: 2021-01-20
In Force
Available languages: English, French
Summary:

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.



Le présent document spécifie les exigences et fournit des recommandations sur les modes opératoires relatifs à 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 œuvre principalement dans des systèmes d'essai biologique, essentiellement en conformité avec une ou à plusieurs parties de la série 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.

Les extractions relatives à la caractérisation chimique sont couvertes par l'ISO 10993-18. Les articles 7, 8, 9, 10 [hormis pour 10.3.5 et 10.3.11 b)], et 11 sont applicables aux extractions relatives à la caractérisation chimique. Les informations fournies de C.1 à C.4 peuvent également être pertinentes.
ICS: 11.100.20-Biological evaluation of medical devices
CTN: ISO/TC 194 - 54508

Standards Cancellations

Anula a ISO 10993-12:2012

Es anulada por

International Equivalence

Identic UNE-EN ISO 10993-12:2022

Modificaciones Normas

Es modificada por ISO 10993-12:2021/DAmd 1

Normas Conjuntas

Trabajo conjunto ISO 20137:2017

The book in the author's words

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