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I.S. EN ISO 10993-18:2020&LC:2020

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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 , PDF

Superseded date

08-02-2024

Language(s)

English

Published date

15-01-2021

Publisher

National Standards Authority of Ireland

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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Symbols and abbreviated terms
5 Characterization procedure
6 Chemical characterization parameters and methods
7 Reporting of the chemical characterization data
Annex A (informative) General principles of chemical characterization
Annex B (informative) Information sources for chemical characterization
Annex C (informative) Principles for establishing biological equivalence
Annex D (informative) Principles of sample extraction
Annex E (informative) Calculation and application of the analytical evaluation threshold (AET)
Annex F (informative) Qualification of analytical methods used for extractables/leachables
Annex G (informative) Reporting details for analytical methods and chemical data
Bibliography

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
ISBN	0-470-85062-0
Pages	92
ProductNote	The date of any NSAIprevious adoption may not matchthe date of its original CEN/CENELEC document
PublisherName	National Standards Authority of Ireland
Status	Superseded
SupersededBy	I.S. EN ISO 10993-18:2020&A1:2023
Supersedes	I.S. EN ISO 10993-18:2020

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

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I.S. EN ISO 10993-18:2020&LC:2020

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

Table of Contents

Abstract

General Product Information

International Equivalents

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