ISO TR 24971:2013 

Medical devices -- Guidance on the application of ISO 14971

CHF 

Do you need a multi-user copy?

CHF 

Preview

Abstract

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.

Look inside


Additional information

Publication typeTechnical Report
Publication date2013-06-19
Edition1.0
Available language(s)English, Russian
TC/SCTC 62/SC 62A - Common aspects of electrical equipment used in medical practicerss
ICS11.040.01 - Medical equipment in general
Stability date  2019
Pages12
File size550 KB

The following test report forms are related:


Share this page


Share your publications

Learn how to share your publications with your colleagues, using networking options.

Payment information

Our prices are in Swiss francs (CHF). We accept all major credit cards (American Express, Mastercard and Visa), PayPal and bank transfers as form of payment.


Keep in touch

Keep up to date with new publication releases and announcements with our free IEC Just Published email newsletter.

Contact customer services

Please send your enquiry by email or call us on +41 22 919 02 11 between 09:00 – 17:00 CET Monday to Friday.