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Technical Committee No |
TC11 |
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Status |
Active |
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Category |
Health Sector |
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Sub Category |
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$Resources:StandardType; |
Kuwaiti Standard |
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.
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Decision No |
9/2022 |
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Decision By |
From Ministers Office |
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Date of Meeting |
24-11-2019 |
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Approval Date |
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Decision Date |
02-06-2022 |
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Newspaper Publication Date |
14-06-2022 |
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Newspaper Number |
1588 |
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