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TNI CEN/TR 17223 (855002)
Guidance on the relationship between EN ISO 13485:2016 (Medical devices - Quality management systems - Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation
Translate name
STANDARD published on 1.10.2019
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The information about the standard:
Designation standards: TNI CEN/TR 17223
Classification mark: 855002
Catalog number: 508655
Publication date standards: 1.10.2019
SKU: NS-972948
The number of pages: 88
Approximate weight : 295 g (0.65 lbs)
Country: Czech technical standard
The category - similar standards:
Annotation of standard text TNI CEN/TR 17223 (855002):
Tato technická zpráva poskytuje návod pro vztah mezi EN ISO 13485:2016 Zdravotnické prostředky - Systémy managementu kvality - Požadavky pro účely předpisů a evropským nařízením 2017/745 o zdravotnických prostředcích a nařízením 2017/746 o diagnostických zdravotnických prostředcích in vitro
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