I.S. EN ISO 10993-18:2020&LC:2020
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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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)
Hardcopy , PDF
08-02-2024
English
15-01-2021
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Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
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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
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