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Glavni meni

ISO TR 24971:2013 ED1

Medical devices -- Guidance on the application of ISO 14971
19. 6. 2013.

Опште информације

99.60     19. 6. 2020.

IEC

TC 62/SC 62A

Tehnički izveštaj

11.040.01  

engleski   ruski  

Kupovina

Revidiran

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Apstrakt

ISO TR 24971:2013 provides guidance in addressing specific areas of ISO 14971 when implementing risk management. This 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.

Životni ciklus

TRENUTNO

POVUČEN
ISO TR 24971:2013 ED1
99.60 Povlačenje stupilo na snagu
19. 6. 2020.

REVIDIRAN OD

OBJAVLJEN
ISO TR 24971:2020 ED2