Medical Device Compliance

04 Aug 2020

IEC 60601-1-3 2nd Amendment

The second amendment of IEC 60601-1 Edition 3:2005 is expected to be published in August and will include several changes and clarifications manufacturers need to be aware of to ensure products remain compliant. These items were flagged as a result of the industry's experience working with the standard's third edition and its first amendment, and were short-listed for immediate attention. Others will be addressed later in the 4th edition, which is not expected prior to 2027. These upcoming changes will mark the standard to be used in medical devices for several years to come, so it remains critical to know and understand them, as well as the standard as a whole.

Amendment 2 improves and further develops requirements of the previous version by updating outdated references, providing more definitions, and correcting or clarifying technical issues. It includes changes that, at first glance, appear minor but could result in previously certified devices not meeting the new requirements. These include:

• Updated terms and definitions to align with ISO 14971:2019
• Changes to the requirements for safety signs, IP classification, batteries, power switches, colors of indicator lights
• Changes/clarifications to the requirements for touch currents, means of protection including creepage distances/clearances, max. mains voltage, working voltage, defibrillation protection and energy reduction, mains fuses/overcurrent releases.
• Changes/clarifications to requirements for pressure vessels and parts subject to pressure, and to support systems (tensile safety factor, dynamic forces due to loading from persons).
• Changes to constructional requirements for fire enclosures
• New table added for temperature limits of accessible parts likely to be touched but not intended to be touched for equipment operation

Additionally, the amendment incorporates acceptance requirements of collateral and reference standards. Collateral standards being update are as follows:

• IEC 60601-1-2 Ed.4 + AMD1: Electromagnetic disturbances – Requirements and tests
• IEC 60601-1-6 Ed.3 + AMD1 + AMD2: Usability
• IEC 60601-1-8 Ed.2 + AMD1 + AMD2: General requirements, tests and guidance for alarm systems
• IEC 60601-1-9 Ed.1 + AMD1 + AMD2: Environmentally conscious design (admin update only)
• IEC 60601-1-10 Ed.1 + AMD1 + AMD2: Development of physiologic closed-loop controllers
• IEC 60601-1-11 Ed.2 + AMD1: Medical electrical equipment and medical electrical systems used in the home healthcare environment
• IEC 60601-1-12 Ed.1 + AMD1: Medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment (admin update only)

The amendment also incorporates acceptance requirements of IEC 62368-1:2018 as an alternative to IEC 60950-1: 2005+AMD1: 2009+AMD: 2013 to demonstrate means of operator protection. Other updated standard references include:

• ISO 14971:2019 for risk management
• IEC 62304:2006+AMD1:2015 for medical device software
• Secondary lithium cells and batteries: IEC 62133-2 for secondary lithium cells and batteries
• IEC 60825-1:2014 for laser products

Learn more about the changes to this standard, and the solutions to help in our complimentary fact sheet.