ISO 10993-18:2020

Published (Edition 2, 2020)

This standard has 1 amendment.

ISO 10993-18:2020

CHF 194

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Abstract

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.

General information

Status
: Published

Publication date
: 2020-01

Stage
: International Standard published [60.60]
Edition
: 2

Number of pages
: 66
Technical Committee :
ISO/TC 194

ICS :
11.100.20
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Amendments

Amendments are issued when it is found that new material may need to be added to an existing standardization document. They may also include editorial or technical corrections to be applied to the existing document.