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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 |
This International Standard specifies requirements for the physical, biological and performance testing of
biocompatible modifications on extracorporeal devices. This International Standard is applicable to components
of heart-lung bypass equipment and of extracorporeal life support equipment that carry blood and have
modifications on the blood and tissue-contacting surfaces of the device.
The assumption is that these devices will be used at conventional ranges of hypothermia and normothermia. If
hyperthermia (>37 °C) applications are indicated, then testing is performed over the indicated range.
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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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