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Norm
ÖNORM EN ISO 10993-7
Issue date: 1996 01 01
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:1995)
This part of IS0 10993 specifies allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in individual EO-sterilized medical devices, procedures...
Withdrawn: 2009 02 01
Publisher:
Austrian Standards International
Format:
Digital | 63 Pages
Language:
German
| English
Currently valid:
Optionally co-design standards:
ICS
This part of IS0 10993 specifies allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in individual EO-sterilized medical devices, procedures for the measurement of EO and
ECH, and methods for determining compliance so that devices may be released. Additional background and guidance also is included in informative annexes EO-sterilized devices that have no patient contact (e.g. in vitro diagnostic devices) are not covered by this
International Standard.
ÖNORM EN ISO 10993-7
2022 10 01
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993...
Norm
ÖNORM EN ISO 10993-7
2010 12 15
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993...
Norm
ÖNORM EN ISO 10993-7
2009 02 01
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993...
Norm
ÖNORM EN ISO 10993-7
1996 01 01
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993...
Norm
↖
Norm
Issue date :
1992 04 23
Biological evaluation of medical devices — Part 1: Guidance on selection of tests
Norm
Issue date :
1992 12 30
Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
Norm
Issue date :
1995 03 09
Biological evaluation of medical devices — Part 10: Tests for irritation and sensitization
Norm
Issue date :
2009 02 01
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)
Norm
Issue date :
1995 10 12
Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
