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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 15198:2004 describes a process for manufacturers of in vitro diagnostic medical devices to validate quality control procedures they recommend to their users. These quality control procedures are intended to provide users with assurance that device performance is consistent with its intended use and the manufacturers' claims. ISO 15198:2004 applies to all in vitro diagnostic medical devices.
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Decision No |
61/2017 |
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Decision By |
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Date of Meeting |
13-03-2017 |
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Approval Date |
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Decision Date |
10-07-2017 |
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Newspaper Publication Date |
23-07-2017 |
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Newspaper Number |
1350 |
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