IEC 80001-1:2021 

Application of risk management for IT-networks incorporating medical devices - Part 1: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software

English/French
CHF 

Do you need a multi-user copy?

English/French
CHF 

Preview

Abstract

IEC 80001-1:2021 specifies general requirements for ORGANIZATIONS in the application of RISK MANAGEMENT before, during and after the connection of a HEALTH IT SYSTEM within a HEALTH IT INFRASTRUCTURE, by addressing the KEY PROPERTIES of SAFETY, EFFECTIVENESS and SECURITY whilst engaging appropriate stakeholders.
IEC 80001-1:2021 cancels and replaces the first edition published in 2010. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) structure changed to better align with ISO 31000;
b) establishment of requirements for an ORGANIZATION in the application of RISK MANAGEMENT;
c) communication of the value, intention and purpose of RISK MANAGEMENT through principles that support preservation of the KEY PROPERTIES during the implementation and use of connected HEALTH SOFTWARE and/or HEALTH IT SYSTEMS.

Look inside


Additional information

Publication typeInternational Standard
Publication date2021-09-21
Edition2.0
Available language(s)English/French
TC/SCTC 62/SC 62A - Common aspects of electrical equipment used in medical practicerss
ICS11.040.01 - Medical equipment in general
35.240.80 - IT applications in health care technology
Stability date  2026
Pages75
File size2307 KB

The following test report forms are related:



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.