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Norm
ÖNORM EN ISO 10993-18
Issue date: 2009 09 15
Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005)
This part of ISO 10993 describes a framework for the identification of a material and the identification and quantification of its chemical constituents. The chemical cha...
Withdrawn: 2020 11 15
Publisher:
Austrian Standards International
Format:
Digital | 25 Pages
Language:
German
| English
| Download GER/ENG
Currently valid:
Optionally co-design standards:
ICS
This part of ISO 10993 describes a framework for the identification of a material and the identification and quantification of its chemical constituents. The chemical characterization information generated can be used for a range of important applications, for example:
As part of an assessment of the overall biological safety of a medical device (ISO 10993-1 and 14971).
Measurement of the level of a leachable substance in a medical device in order to allow the assessment of compliance with the allowable limit derived for that substance from health based risk assessment (ISO 10993-17).
ÖNORM EN ISO 10993-18
2021 02 15
Biological evaluation of medical devices - Part 18: Chemical characterization of medical device mate...
Norm
ÖNORM EN ISO 10993-18
2020 11 15
Biological evaluation of medical devices - Part 18: Chemical characterization of medical device mate...
Norm
ÖNORM EN ISO 10993-18
2009 09 15
Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 1099...
Norm
↖
ÖNORM EN ISO 10993-18
2005 10 01
Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 1099...
Norm
Norm
Issue date :
2002 11 27
Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
Norm
Issue date :
2003 07 28
Biological evaluation of medical devices — Part 1: Evaluation and testing
Norm
Issue date :
2002 11 27
Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
Norm
Issue date :
2000 11 30
Medical devices — Application of risk management to medical devices
Norm
Issue date :
2020 11 15
Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020)
Norm
Issue date :
2005 06 30
Biological evaluation of medical devices — Part 18: Chemical characterization of materials
