In July 2014, the FDA recognized the 4th edition of IEC 60601-1-2 as a standard that can be used to show EMC compliance for medical electrical devices and systems.
The complete standard is recognized with the following exception:
In Subclause 8.9, Table 8 on Page 39: The citation of Note b) under “Conducted disturbances induced by RF fields” (4th Row) is not recognized.
Starting on April 1, 2017 the FDA will no longer accept declarations of conformity in support of either IEC 60601-1-2 Edition 3:2007 or ANSI/AAMI/IEC 60601-1-2:2007. This recognition affects all electrical medical devices, except for active implanted devices.
However, a new FDA publication “Design Considerations for Devices Intended for Home Use – Guidance for Industry and Food and Drug Administration Staff” suggests using the 4th edition of IEC 60601-1-2 for Home Healthcare environments now (not 2017!) to cover test levels which may not be properly addressed in the 3rd edition.
Some of the changes to the 4th edition from the 3rd edition of IEC 60601-1-2 are:
- With regards to electromagnetic environments, the “life supporting equipment” category has been removed
- CISPR 15 has been removed as an option for lighting features, replaced by CISPR 11
- ESD test levels were increased for both air and contact type discharges
- RF susceptibility test levels are now specified based on the intended use environment
- Transient tests on DC input power ports in accordance with ISO 7637-2 have been added
- New conducted RF disturbances requirements are based on location of intended use
- Test levels for power frequency magnetic fields increased tenfold, to 30 A/m
- Testing is now at multiple phase angles for the half-cycle, 100% voltage dip
There are many other changes in the 4th edition, contact MET Labs to schedule a new product discovery or existing product ‘gap analysis.’
MET is a leading independent test lab for medical equipment approvals for product safety, EMC and performance. Learn more about Medical Compliance Testing.