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Norm
ISO 10993-7:2008
Ausgabedatum: 2008 10 13
Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
ISO 10993-7:2008 specifies allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in individual EO-sterilized medical devices, procedures for t...
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Herausgeber:
International Organization for Standardization
Format:
Digital | 86 Seiten
Sprache:
Englisch
ICS
ISO 10993-7:2008 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 the standard is applied are also included in informative annexes.
EO-sterilized devices that have no patient contact (e.g., in vitro diagnostic devices) are not covered by ISO 10993-7:2008.
ISO 10993-7:2008
2008 10 13
Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
Norm
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ISO 10993-7:1995
1995 10 12
Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
Norm