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SS-EN ISO 10993-18:2020

Current
Current

The latest, up-to-date edition.

Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020)
Available format(s)

Hardcopy

Language(s)

English

Published date

06-02-2020

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).

Committee
TC 194
DocumentType
Standard
Pages
0
PublisherName
Standardiserings-Kommissionen I Sverige
Status
Current
Supersedes

Standards Relationship
ISO 10993-18:2020 Identical
EN ISO 10993-18:2020 Identical

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