IEC 60601-1:2020 – Medical Electrical Equipment – General Requirements for Basic Safety and Essential Performance, 2020

IEC 60601-1:2020 – Medical Electrical Equipment – General Requirements for Basic Safety and Essential Performance consolidates the foundational requirements from the 2005 base edition and Amendments 1 (2012) and 2 (2020). It is the definitive international standard for ensuring the safety and performance of medical electrical devices and systems used in patient care.

Highlights:

• Applies to the basic safety and essential performance of electrical medical equipment and systems
• Addresses hazards related to electrical shock, mechanical failure, thermal effects, and radiation
• Integrates risk management aligned with ISO 14971 for hazard control and usability
• Specifies labeling, documentation, and marking requirements for product traceability and safe use
• Supports conformity assessment and global regulatory submissions

2020 Amendment Highlights:

• Clarified terminology and pass/fail testing criteria
• Updated guidance for software safety, usability engineering, and wireless technologies
• Enhanced alignment with IEC 60601-1 collateral standards (e.g., -1-2 for EMC, -1-6 for usability)

Who It’s For:
Medical device engineers, regulatory specialists, QA professionals, and test labs involved in the design, validation, and certification of medical electrical equipment for international markets.

IEC 60601-1:2020