IEC 60601-1 covers general requirements for basic safety and essential performance of medical electrical equipment and systems. The third edition of the standard was published in 2005, with an amendment issued in 2012. Now, the second amendment of the standard is being published. This amendment will include several changes and clarifications manufacturers must be aware of to ensure products remain compliant.

The items addressed in the second amendment were flagged in response to industry input after working with the standard’s third edition and its first amendment. These concerns were short-listed for immediate attention and include things such as technical error corrections, removal of inconsistencies, and updated standard references. These short-listed concerns are being addressed with this amendment, which was started in late 2016, approved in June of this year, and is now being published for the industry.

Other concerns, which were not considered to be as high of a priority, were added to a “long list” and will be addressed later in the 4th edition of the standard. This is not expected prior to 2027. As such, the changes and revisions of the second amendment will mark the standard to be used in medical devices for several years to come. It is critically important for manufacturers to know and understand the latest edition, its changes, and the standard as a whole in order to ensure timely, cost-effective, and successful product development and launches.

Changes and Updates
IEC 60601-1 3^rd Edition, Amendment 2 both improves and further develops requirements of the previous version of the standard by updating outdated references, providing more definitions, and correcting or clarifying technical issues. It includes changes that appear minor at first glance, but could result in previously certified devices no longer being compliant. These changes include:
 

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

Additionally, the amendment incorporates acceptance requirements of collateral and reference standards. The following collateral standards are being updated:
 

• 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)

Regarding reference standards, the amendment incorporates acceptance requirements of IEC 62368-1:2018 as an alternative to IEC 60950-1: 2005+AMD1: 2009+AMD: 2013 to demonstrate operator protection. Other updated standard references include:
 

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

Best Practices
To prepare for the changes under the second amendment, medical device manufactures should familiarize themselves with the new changes and guidance. By understanding the challenges identified in previous versions of the standard as well as the new requirements to address them, manufacturers can be better prepared to develop products in line with the requirements, and better illustrate their compliance. As these become mandatory in the coming years, familiarity will speed time to market and help reduce costs in both time and money related to retesting and product development.
 
Once you know and understand the new requirements, build testing plans for new products that address these needs. These may include new or additional tests related to EMC, batteries, lasers, electrical safety, materials, or performance. Evaluate products accordingly and document results to illustrate compliance.
 
Work with your testing and certification partner to ensure your new and existing products meet the new requirements set in the second amendment. Knowledgeable partners will know and understand the new requirements and work with you to identify testing and certification needs, build a test plan, and implement the plan to fully assess products in a timely, effective manner.