Earlier this year (Feb) the International Electrotechnical Commission IEC) released the IEC60601-1-2 (2014) 4th Edition standard, Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests.
It has been 8 years since the third edition was released, and the new standard is already recognized by the FDA as recognition number 19.8, with the 3rd edition and ANSI version being recognized until Aug 1, 2016. Testing of legacy products is not required, unless a major change to the product has occurred.
In Europe, CENELEC have voted to adopt the new standard, and it usually takes between 6 and 12 months after publication date for an important standard like this to become a harmonized EN standard. Once the EN standard is published, it is mandatory, and, according to the Medical Device Directive, the manufacturer must demonstrate compliance to state of the art, hence no grandfathering.
Health Canada still recognizes 2nd Edition of 60601-1-2, with no clear guidelines on when 4th edition will be mandatory, but it can be several years.
The standard has changed name, from ‘Electromagnetic compatibility – Requirements and tests’ to ‘Electromagnetic disturbances – Requirements and test’. This gives an indication that the emphasis is shifting from simply meeting a set of predefined standards to a risk based approach, as is common with other standards. The emphasis is now on maintaining basic safety and essential performance, not just trying to comply with Class A or B.
For example, in addition to classifying the area the device is used in as Professional or home/Residential, there are now special environments where specific disturbances may be occur. These include devices intended for use in the vicinity of high frequency ablation equipment or outside an MRI shielded room. For home use, the immunity requirements have been harmonized with the home use Standard IEC60601-1-11. Immunity to wireless equipment, such as cell phones, is also considered with a separation distance of only 30cm. All this is in addition to an increase in the previous ESD immunity tests of 8kV contact, 15kV air discharge (from 6 and 8 previously), and 2.7GHz radiated (up from 2.5GHz in the previous edition compared to only 1GHz for the IEC60950-1 IT equipment safety standard).
There is also a requirement to continue to test a product that has already been damaged by an immunity test, such as ESD, and increased RF immunity at multiple radio frequency bands such as Radio Amateur, LTE, GSM, Bluetooth, Scientific and Medical (ISM), WiFi, TETRA and others.
Essentially, the standard requires the manufacturer to:
- State the intended usage environment, also considering Normal use.
- Consider the maximum reasonably foreseeable emissions and immunity levels.
- Perform an EMC risk analysis and implement mitigations which maintain basic safety and essential performance, or permits degradation provided it does not result in unacceptable risk.
- Develop an EMC testing plan which considers operating modes that maximize emissions, and should also consider standby modes, and includes representative worst case configurations. Note that special hardware, phantoms and software test modes may be required.
- Perform the more restrictive tests.
- Justify that any increased emissions or reduced immunity does not increase risk of harm to a patient or operator in a report as part of risk management.
For more details, see:
- Purchase the 60601-1-2 (2014) Standard from IEC
- TüV Rhineland White Paper on IEC60601-1-2 4th Edition
- Intertek Webinar
Vincent Crabtree, PhD is a Regulatory Advisor & Project Manager at StarFish Medical. He welcomes comments and feedback from readers regarding his articles.