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Publication details

Publication CODE Title
ISO TR 24971:2013 (2013-06) MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 14971
 
Price Excl. VAT Total number of pages, tables and drawings
67.00 € 12 P.
Description
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.
Class  C990  (IEC PUBLICATIONS IEC PUBLICATIONS)
Available files
EN version

Status
Status TECHNICAL REPORT
Situation Withdrawn
Replaced by  ISO TR 24971:2020
Origin
Committee TC 62/SC 62A
COMMON ASPECTS OF ELECTRICAL EQUIPMENT USED IN MEDICAL PRACTICE
Responsible De heer VAN HECKE Luk
Approval
BEC Approval 2013-06-19
Registration 136742
ICS-Code (International Standards Classification) 11.040.01
NBN Status New
IEC publication date 2013-06-19