DS/ISO/TR 24971:2013 ( Withdrawn )

Medical devices - Guidance on the application of ISO 14971


Status:
Withdrawn
Type:
Standard
Language:
EN
Subject:
Replaced by:
Price from:
€ 56.83

Scope

This Technical Report 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.

Number of pages: 24

Published: 2013-07-19

Date of approval: 2013-07-04

Date of withdrawal: 2020-06-22

International relationships : ISO/TR 24971:2013 IDT

ICS: 11.040.01 - Medical equipment in general

Item number: M273000


Committees

Committee

  • ISO/TC 210

Danish committee

DS/S-257