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I.S. EN ISO 10993-18:2020

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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

I.S. EN ISO 10993-18:2020&A1:2023

Available format(s)

Hardcopy , PDF

Superseded date

02-06-2021

Language(s)

English

Published date

06-14-2020

Publisher

National Standards Authority of Ireland

Preview

For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

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
Pages
90
ProductNote
The date of any NSAI previous adoption may not matchthe date of its original CEN/CENELEC document.
PublisherName
National Standards Authority of Ireland
Status
Superseded
SupersededBy
Supersedes

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

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Hardcopy - English
PDF - English
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