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Norm
ÖNORM EN ISO 10993-7
Issue date: 2009 02 01
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)
This part of ÖNORM EN ISO 10993 specifies allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in individual EO-sterilized medical devices; p...
Withdrawn: 2010 12 15
§ Legal References
Publisher:
Austrian Standards International
Format:
Digital | 105 Pages
Language:
German
| English
Currently valid:
Optionally co-design standards:
ICS
This part of ÖNORM EN 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 and guidance and a flowchart showing how the standard is applied are also includeed in informative annexes. EO-sterilized devices that have no patient contact (e.g., in vitro diagnostic devices) are not covered by this 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
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Issue date :
2009 10 13
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Biological evaluation of medical devices — Part 12: Sample preparation and reference materials (Corrected version 2008-02)
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Biological evaluation of medical devices — Part 12: Sample preparation and reference materials
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Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
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2018 08 17
Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process (Corrected version 2018-10)
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2014 09 24
Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
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Issue date :
2002 11 27
Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
Norm
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)
Norm
Issue date :
2008 10 13
Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
