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sklademVydáno: 2008
ISO 10993-7:2008
ISO 10993-7:2008-Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
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Anglicky PDF
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Francouzsky PDF
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6600 Kč
Anglicky Tisk
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Francouzsky Tisk
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| Označení normy: | ISO 10993-7:2008 |
| Počet stran: | 86 |
| Vydání: | 2 |
| Vydáno: | 2008 |
| Počet stran (Anglicky): | 86 |
| Počet stran (Francouzsky): | 86 |
Popis
ISO 10993-7:2008
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.