Standard Technical reports · SIS-CEN ISO/TR 24971:2020

Medical devices - Guidance on the application of ISO 14971 (ISO/TR 24971:2020)

Status: Valid

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Standard Technical reports · SIS-CEN ISO/TR 24971:2020

Medical devices - Guidance on the application of ISO 14971 (ISO/TR 24971:2020)
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Scope
This document provides guidance on the development, implementation and maintenance of a risk management system for medical devices according to ISO 14971:2019.
The risk management process can be part of a quality management system, for example one that is based on ISO 13485:2016[24], but this is not required by ISO 14971:2019. Some requirements in ISO 13485:2016 (Clause 7 on product realization and 8.2.1 on feedback during monitoring and measurement) are related to risk management and can be fulfilled by applying ISO 14971:2019. See also the ISO Handbook: ISO 13485:2016 — Medical devices — A practical guide[25].

Subjects

For specific equipment (01.080.20) General (11.040.01) General (11.120.01)


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Standard Technical reports · SIS-CEN ISO/TR 24971:2020

Medical devices - Guidance on the application of ISO 14971 (ISO/TR 24971:2020)
Subscribe on standards - Read more Dölj
Price: 1 570 SEK
standard ikon pdf

PDF

Price: 1 570 SEK
standard ikon

Paper

Price: 2 512 SEK
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PDF + paper

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Product information

Language: English

Written by: Std Vård

International title:

Article no: STD-80023881

Edition: 1

Approved: 9/2/2020

No of pages: 100

Replaces: SIS-ISO/TR 24971:2020