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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)
This part of ISO 10993 specifies allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in individual EO-sterilized medical devices, procedures...
Valid
Publisher:
Austrian Standards International
Format:
Digital | 107 Pages
Language:
German
| English
Optionally co-design standards:
ICS
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
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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 :
2018 08 17
Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process (Corrected version 2018-10)
Norm
Issue date :
2014 09 24
Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
Norm
Issue date :
2002 11 27
Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
