Medical devices — Guidance on the application of ISO 14971

Designation Number:
ISO 24971
Standard Type:
National Standard of Canada - Adoption of International Standard
Standard Development Activity:
New Standard
ICS code(s):
11.040.01
Status:
Proceeding to development
SDO Comment Period Start Date:
SDO Comment Period End Date:
Posted On:

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

Project need:

To maintain alignment with international requirements (ISO/TR 24971-2020). Additionally, a lot of guidance information and annexes have been moved from ISO 14971 to this technical report. As such, the Z289 TC recommended that this technical report should be adopted as this document acts as an extension to the ISO 14971 standard.

Note: The information provided above was obtained by the Standards Council of Canada (SCC) and is provided as part of a centralized, transparent notification system for new standards development. The system allows SCC-accredited Standards Development Organizations (SDOs), and members of the public, to be informed of new work in Canadian standards development, and allows SCC-accredited SDOs to identify and resolve potential duplication of standards and effort.

Individual SDOs are responsible for the content and accuracy of the information presented here. The text is presented in the language in which it was provided to SCC.