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Standard TNI CEN ISO/TR 24971 1.10.2022 preview

TNI CEN ISO/TR 24971 (855230)

Medical devices - Guidance on the application of ISO 14971

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STANDARD published on 1.10.2022


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The information about the standard:

Designation standards: TNI CEN ISO/TR 24971
Classification mark: 855230
Catalog number: 515365
Publication date standards: 1.10.2022
SKU: NS-1086728
The number of pages: 102
Approximate weight : 337 g (0.74 lbs)
Country: Czech technical standard

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The category - similar standards:

Medical equipment in general

Annotation of standard text TNI CEN ISO/TR 24971 (855230):

Tento dokument poskytuje návod pro vývoj, implementaci a udržování systému managementu rizik pro zdravotnické prostředky podle ISO 14971:2019. Proces managementu rizik může být součástí systému managementu kvality, například systému založeného na ISO 13485:2016, ale ISO 14971:2019 to nevyžaduje. Některé požadavky v ISO 13485:2016 (kapitola 7 o realizaci produktu a 8.2.1 o zpětné vazbě během monitorování a měření) souvisejí s managementem rizik a lze je splnit aplikací ISO 14971:2019

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