ISO 10993-18:2020

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Publicado (Edición 2, 2020)

Esta norma tiene 1 modificaciones.

ISO 10993-18:2020

CHF 194

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Resumen

This document specifies a framework for the identification, and if necessary, quantification of constituents of a medical device, allowing the identification of biological hazards and the estimation and control of biological risks from material constituents, using a generally stepwise approach to the chemical characterization which can include one or more of the following:

— the identification of its materials of construction (medical device configuration);

— the characterization of the materials of construction via the identification and quantification of their chemical constituents (material composition);

— the characterization of the medical device for chemical substances that were introduced during manufacturing (e.g. mould release agents, process contaminants, sterilization residues);

— the estimation (using laboratory extraction conditions) of the potential of the medical device, or its materials of construction, to release chemical substances under clinical use conditions (extractables);

— the measurement of chemical substances released from a medical device under its clinical conditions of use (leachables).

This document can also be used for chemical characterization (e.g. the identification and/or quantification) of degradation products. Information on other aspects of degradation assessment are covered in ISO 10993-9, ISO 10993-13, ISO 10993-14 and ISO 10993-15.

The ISO 10993 series is applicable when the material or medical device has direct or indirect body contact (see ISO 10993-1 for categorization by nature of body contact).

This document is intended for suppliers of materials and manufacturers of medical devices, to support a biological evaluation.

Informaciones generales

Estado
: Publicado

Fecha de publicación
: 2020-01

Etapa
: Norma Internacional publicada [60.60]
Edición
: 2

Número de páginas
: 66
Comité Técnico :
ISO/TC 194

ICS :
11.100.20
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Modificaciones

Las enmiendas se emiten cuando se decide que puede ser necesario agregar nuevo material a un documento de normalización existente. También pueden incluir correcciones editoriales o técnicas que deban aplicarse al documento existente.