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eLibrary > BS EN ISO 10993-18:2020 Biological evaluation of medical devices - Chemical characterization of medical device materials within a risk management process >

BS EN ISO 10993-18:2020 Biological evaluation of medical devices - Chemical characterization of medical device materials within a risk management process, 2020

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BS EN ISO 10993-18:2020 Biological evaluation of medical devices - Chemical characterization of medical device materials within a risk management process, 2020

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Annex ZA (informative)Relationship between this European standard and the General Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered
Annex ZB (informative)Relationship between this European Standard and the essential requirements of Directive 90/385/EEC [OJ L 189] aimed to be covered
Annex ZC (informative)Relationship between this European standard and the General Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered [Go to Page]
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Symbols and abbreviated terms
5 Characterization procedure
5.1 General
5.2 Establish medical device configuration and material composition
5.2.1 General
5.2.2 Information gathering
5.2.3 Information generation
5.3 Assess material/chemical equivalence to a clinically established material or medical device
5.4 Assess the hypothetical worst-case chemical release based on total exposure to the medical device’s chemical constituents
5.4.1 Establish the hypothetical worst-case chemical release
5.4.2 Assess the hypothetical worst-case chemical release
5.5 Establish an analytical evaluation threshold
5.6 Estimate the chemical release; perform extraction study
5.7 Assess the estimated chemical release (extractables profile)
5.8 Determine the actual chemical release; perform leachables study
5.9 Assess the actual chemical release (leachables profile)
5.10 Exiting the chemical characterization process
6 Chemical characterization parameters and methods
6.1 General
6.2 Material composition
6.3 Extractables and leachables
6.4 Structural composition or configuration
6.5 Analytical 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 [Go to Page]

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BS EN ISO 10993-18:2020 Biological evaluation of medical devices - Chemical characterization of medical device materials within a risk management process, 2020

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