|
Technical Committee No |
TC11 |
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Status |
Replaced |
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Category |
Health Sector |
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Sub Category |
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$Resources:StandardType; |
Kuwaiti Standard |
ISO 14708-5:2010 specifies requirements for safety and performance of active implantable circulatory support devices. It is not applicable to extracorporeal perfusion devices, cardiomyoplasty, heart restraint devices and counter-pulsation devices, such as extra- or intra-aortic balloon pumps.
ISO 14708-5:2010 specifies type tests, animal studies and clinical evaluation requirements.
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|
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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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