ISO TR 24971:2013 ED1

Medical devices -- Guidance on the application of ISO 14971

Publication date: 19 qer 2013

General information

Current stage: 99.60 Effective date: 19 qer 2020

Originator: IEC

Owner: TC 62/SC 62A

Type: Technical Report

ICS: 11.040.01

Gjuha: anglisht rusisht

Buying

Statusi: Revised

PDF - 7 576 Lekë

Paper - 7 576 Lekë

CD - 7 576 Lekë

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Scope

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.

Life cycle

NOW

WITHDRAWN
ISO TR 24971:2013 ED1
99.60 Withdrawal effective
19 qer 2020

REVISED BY

PUBLISHED
ISO TR 24971:2020 ED2