Committee Draft
IEC/CD TS 81001-2-2
Health software and health IT systems safety, effectiveness and security — Part 2-2: Guidance for the implementation, disclosure and communication of security needs, risks and controls
Reference number
IEC/CD TS 81001-2-2
Edition 1
© ISO 2025
Committee Draft
Under development
A draft is being reviewed by the committee.
Will replace IEC/TR 80001-2-2:2012 | IEC/TR 80001-2-8:2016

Abstract

This document presents an informative set of common, high-level security-related capabilities and additional considerations to be used across the entire life cycle of HEALTH SOFTWARE (including MEDICAL DEVICE software) and for the information exchange between the MEDICAL DEVICE MANUFACTURERS (MDMs), health software manufacturers, HEALTH DELIVERY ORGANIZATIONS (HDOs) and/or other stakeholders.

General information

Life cycle

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goals

3
Good Health and Well-being
9
Industry, Innovation and Infrastructure

Got a question?

Check out our Help and Support

  2. Store
  3. Store
  4. TC
  5. ISO/TC 215
  6. IEC/CD TS 81001-2-2