In an effort to remain current with new medical technologies, product safety standard IEC 60601-1 underwent another revision with the 2012 publication of Amendment 1. More than 100 pages in length, Amendment 1 (Edition 3.1) introduces more than 20 new requirements and 60 modifications to existing requirements for medical devices.
For manufacturers of medical electrical equipment and systems, IEC 60601-1 Edition 3.1 (or IEC 60601-1:2005+AMD1:2012) represents a significant departure from Edition 3.0 of the standard. While the application of risk management principles has been clarified, the amended standard includes new requirements regarding essential performance, mandates usability engineering evaluations, and requires the adoption of a formal development life cycle process for software. The amended standard also includes a number of new or revised technical specifications for electrical and mechanical hazards, as well as new product labeling and documentation requirements.
This Compliance Today blog post provides an overview of the new and modified requirements included in IEC 60601-1 Edition 3.1.
Risk Management (Subclause 4.2)
The description of risk management has been rewritten to clarify how ISO 14971:2007 should be applied. The rewrite clarifies that a full ISO 14971 assessment and post-production monitoring are not required for compliance.
Essential Performance (Subclause 4.3)
Amendment 1 now requires manufacturers to establish specific performance limits, and to evaluate essential performance characteristics under abnormal or fault conditions. In addition to these changes, essential performance is now a test criteria in assessing if a hazard is present after a specific test. Also, manufacturers must declare specific essential performance criteria in the product’s technical description.
Humidity (Subclause 5.7)
Humidity testing requirements from IEC 60601-1 Edition 2.0 have been reinstated.
Documentation (Clause 7)
A number of new documentation requirements for user manuals and instructions for use (IFU) have been added. In addition, electronic versions of all accompanying documentation must apply the usability engineering process as covered in the collateral standard, IEC 60601-1-6, Usability, in determining what information must be presented.
Marking and Labeling (Subclause 7.2.2)
Equipment and accessory labeling must include a unique serial number or lot batch identifier, date of manufacturer or “use-by” date, and manufacturer contact information.
Electrical Hazards (Clause 8)
There are a number of changes related to protections from potential electrical hazards, including defibrillation protection, protective earth and creepage and clearance distances. There are new limits for leakage current testing for functional earth connections. Protective earth testing with a power supply cord is required for devices equipped with appliance inlets. Permanently installed equipment must include a power lockout device if reconnection presents a potential hazard to a user.
Mechanical Hazards (Clause 9)
Testing for mechanical hazards related to instability and mobile equipment has been modified to include functional testing.
Temperature Testing (Clause 11)
For applied parts, temperature limits have been clarified. For overflow, equipment must be designed to ensure that basic safety and essential performance are maintained at all times.
Programmable Electrical Medical Systems (PEMS) (Clause 14)
Amendment 1 incorporates many of the specific requirements of IEC 62304:2006, Medical Device Software Life Cycle Processes, which are applicable to equipment and systems whose operation depends on software or any programmable element (also known as PEMS). In addition, Amendment 1 incorporates validation requirements for equipment connected to a network.
Construction (Clause 15)
For mechanical strength, “basic safety and essential performance” replaces “unacceptable risk.” Requirements for the construction of transformers have reverted to IEC 60601-1 Edition 2.0. Lithium batteries must comply with IEC 60086-4 (primary cells) and IEC 62133 (secondary cells).
The U.S. FDA has set a transition date of August 2016 for compliance with Edition 3.1. For the NRTL program, the U.S. Occupational Safety and Health Administration (OSHA) has adopted ANSI/AAMI ES60601-1: 2005/(R2012) and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012. Both of these national standards are deemed the equivalent of IEC 60601-1 Edition 3.1, but they may also include national deviations that trigger additional requirements for regulatory approval. Thus, there is some uncertainty around transition dates.
In the European Union (EU), EN 60601-1:2006/A1:2013 (the EU’s equivalent of IEC 60601-1 Edition 3.1) has been published in the Official Journal (OJ) as a harmonized standard under the EU’s Medical Device Directive (93/42/EEC). So, as of Dec. 31, 2017, compliance with the provisions of EN 60601-1: 2006 (equivalent to IEC 60601-1 Edition 3.0) will no longer be accepted as evidence of conformity with the essential requirements of the Directive.
Adding another level of complexity, transition dates for equipment and systems subject to the requirements of a collateral and/or particular standard in the IEC 60601 series (designated IEC 60601-1-xx and IEC 60601-2-xx) may differ from those applicable to other types of devices.
For device manufacturers that use the IECEE’s CB Scheme, a further challenge is the requirements presented in the IECEE’s Operational Document OD-2055. Published in 2014, OD-2055 requires manufacturers seeking certification to IEC 60601-1 as amended to also comply with the usability engineering process that is detailed in IEC 62366-1:2015.
MET Labs is a leading agency for 3rd party testing and certification of medical electrical equipment to the latest edition of IEC 60601-1 for all major markets. Contact us for questions about Edition 3.1 or for a free quotation to test your device(s).