IEC 60601-1-2: “Medical Electrical Equipment–General requirements for basic safety and essential performance–Electromagnetic disturbances–Requirements and tests”
IEC 60601-1-2 is a key standard for those seeking to certify electrically powered medical devices, whether for a hospital, home healthcare, or other environment. It can be purchased for an eye-wateringly high price here (ANSI) or for somewhat less from here (IEC). The current revision is from 2014, but there was an extensive amendment in 2021, so make sure you’re either buying both documents or one document that incorporates both the 2014 and 2021 information.
Section 4 defines a risk management approach for both medical systems and the incorporation of non-medical devices (such as a standard power supply) into a larger medical system. The approach is based on that of ISO 14971. There’s an interesting description of the construction of an artificial hand, when needed, in terms of appropriate capacitance and resistance. Section 5 describes the documentation and markings needed for the product and product literature depending on compliance to the standard.
Section 7 describes the emissions requirements that should apply to different kinds of equipment in different operating modes. Some of the subsections are on very specific cases, such as X-ray equipment, or things that cannot be moved into an EMC chamber. The main requirements specified include:
Harmonic distortion to protect the public mains grid, as per IEC 61000-3-2
Voltage fluctuations and flicker to protect the public mains grid, per IEC 61000-3-3
Radiated emissions, per CISPR 11
Section 8 covers the immunity requirements. As always, it’s a more extensive list:
ESD, per IEC 61000-4-2
Radiated immunity, per IEC 61000-4-3
Fast transients, per IEC 61000-4-4
Power surges, per IEC 61000-4-5
Conducted immunity, per IEC 61000-4-6
Magnetic field immunity per IEC 61000-4-8 and -4-39 (the latter may be met by analysis)
Voltage dips and interruptions, per IEC 61000-4-11
Electrical transients, per ISO 7637-2
There is a lot of information given about different test conditions, defining different environments, how to proceed in case of an immunity failure, etc. There’s also an extremely informative Annex A with rationale on just about everything included in the standard–my favorite kind of Annex! Plus additional Annexs B - I with additional context, especially in how IEC 60601-1-2 interacts with other standards such as CISPR 11.