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Norm

ÖNORM EN ISO 10993-7

Issue date: 2010 12 15

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008 + Cor 1:2009) (consolidated version)

This part of ISO 10993 specifies allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in individual EO-sterilized medical devices, procedure...
Withdrawn: 2022 10 01
Publisher:
Austrian Standards International
Format:
Digital | 106 Pages
Language:
German | English | Download GER/ENG
Optionally co-design standards:
This part of ISO 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, including guidance and a flowchart showing how this document is applied, are also included in the informative annexes. EO-sterilized devices that have no patient contact (e.g., in vitro diagnostic devices) are not covered by this part of ISO 10993.
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
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ISO 10993-1:2009
Issue date : 2009 10 13
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ISO 10993-17:2002
Issue date : 2002 11 27
Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
Norm
ÖNORM EN ISO 10993-7
Issue date : 2022 10 01
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008 + Cor 1:2009 + Amd 1:2019) (consolidated version)
Norm
ISO 10993-7:2008
Issue date : 2008 10 13
Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals