In February 2014, the IEC published IEC 60601-1-2:2014, ed 4.0 for Medical EMC. There are a number of changes in the 4th edition, including new immunity and risk analysis requirements.
For new products in the U.S., the FDA will make a decision on the 4th edition this July, with a likely 3-year transition period (2017 recognition). The FDA does not currently require retesting of legacy products unless changes are made to the product that may affect its compliance.
Canada is planning to review the 4th Edition sometime in 2015 so it will not be accepted before 2015/2016. It’s typically 3 years before accepted standards are required for new submittals.
In Europe, CENELEC has voted affirmatively to accept the 4th edition but has not set a date to withdrawal (DOW) the 3rd edition. The DOW of the current 3rd Edition is expected in the 2017-2018 timeframe. There is no grandfathering in Europe.
Following are some of the key changes in the 4th edition.
Use environments are split into three areas:
- Professional Healthcare Facility Environment
- Home Healthcare Environment
- Special Environment (test levels specified in Annex E)
Small clinic, and Home use equipment need CISPR 11 Class B emission, IEC 61000-3-2 Class A harmonic distortion, and IEC 61000-3-3 voltage fluctuation and flicker. The home use equipment needs 10 V/m, 80 MHz to 1 GHz immunity.
For equipment that is installed in an aircraft or an ambulance, additional testing per ISO 7137 and CISPR 25 applies.
For an EUT with auto ranging power supply, most tests are required to be performed at one nominal voltage only. Only voltage interruptions need to be performed at maximum and minimum voltage if the rated voltage range is >25% of lowest rated input voltage.
Immunity test levels increase:
- The range of testing for radiated immunity harmonized up to 2.7GHz (up from 2.5GHz in the 3rd edition)
- Magnetic immunity at 30A/m
- Conducted immunity at 6V in ISM bands
- ESD at 8kV contact and 15kV air (up from 6kV and 8kV in the 3rd edition)
- Voltage dips and interruptions at additional phase angles
In addition to these Immunity changes:
- Immunity levels (Table 9) are harmonized with IEC 60601-1-11
- Immunity testing now follows the same port-by-port convention of the IEC 61000-6 series of Generic EMC standards
- Immunity to proximity fields from RF wireless communications equipment is now included, and is based on a minimum separation distance of 30cm
- There is a procedure for continuing to test a product that is damaged by an immunity test signal
And Risk Management is expanded:
- Manufacturers will be required to submit a test plan and the risk analysis document before testing
- Operating modes are based on risk analysis
- Reasonably foreseeable electromagnetic disturbances (Annex F) shall be taken into account in the risk management process
- The risk management process is used to determine whether subsystem testing is allowed
- The minimum separation distance are considered in the risk management process
- Reduced test levels (e.g. based on the intended use of the product) must be justified in the risk management file
Contact us for questions about these changes or for a free quote to test and certify medical equipment to any edition of 60601-1.