IEC 81001-5-1:2021 — Health software and health IT systems safety, effectiveness and security — Part 5-1: Security

Defines security requirements and recommendations for the product life cycle of health software. IEC 81001-5-1 covers security risk management, secure design and development, security testing, vulnerability management, and post-market cybersecurity activities. Harmonized under the EU MDR/IVDR and increasingly required by regulatory authorities worldwide for connected medical devices and health IT systems.

Standard Details

• Standard Number: IEC 81001-5-1:2021
• Type: IEC Standard
• Published by: IEC
• Official Link: https://webstore.iec.ch/en/publication/34263

This standard is referenced in the harmonized standards lists for the EU Medical Device Regulation (MDR) 2017/745, EU In Vitro Diagnostic Regulation (IVDR) 2017/746, and is recognized by regulatory authorities worldwide including the FDA, Health Canada, and TGA.