Standard Technical reports · SIS-ISO/TR 24971:2014

Medical devices - Guidance on the application of ISO 14971 (ISO/TR 24971:2013, IDT)

Status: Withdrawn

· Replaced by: SIS-ISO/TR 24971:2020
Buy this standard

Standard Technical reports · SIS-ISO/TR 24971:2014

Medical devices - Guidance on the application of ISO 14971 (ISO/TR 24971:2013, IDT)
Subscribe on standards - Read more Dölj
Price: 793 SEK
standard ikon pdf

PDF

Price: 793 SEK
standard ikon

Paper

Price: 1 268,80 SEK
standard ikon pdf + standard ikon

PDF + paper

Show more Show less
Scope
This Technical Report provides guidance in addressing specific areas of ISO 14971 when implementing risk management.

The guidance is intended to assist manufacturers and other users of the standard to:
— understand the role of international product safety and process standards in risk management;
— develop the policy for determining the criteria for risk acceptability;
— incorporate production and post-production feedback loop into risk management;
— differentiate between “information for safety” and “disclosure of residual risk”; and
— evaluate overall residual risk.

Subjects

General (11.040.01) Quality management and corresponding general aspects for medical devices (11.110.10)


Buy this standard

Standard Technical reports · SIS-ISO/TR 24971:2014

Medical devices - Guidance on the application of ISO 14971 (ISO/TR 24971:2013, IDT)
Subscribe on standards - Read more Dölj
Price: 793 SEK
standard ikon pdf

PDF

Price: 793 SEK
standard ikon

Paper

Price: 1 268,80 SEK
standard ikon pdf + standard ikon

PDF + paper

Show more Show less

Product information

Language: English

Written by: SIS - Hälso- och sjukvård

International title:

Article no: STD-103217

Edition: 1

Approved: 10/17/2014

No of pages: 28

Replaced by: SIS-ISO/TR 24971:2020