EMC (Electromagnetic Compatibility) Requirements - IEC 60601 3rd edition Clause 17

This small section is confusing to me. It is saying we need to run EMC to 60601-1-2 to be compliant with 60601-1 3rd edition? Or is it just saying EMC will be part of the Risk Management File?

We ran 60601-1-2 a few years ago. Does it need to be run again as part of 3rd edition?

Re: EMC (Electromagnetic Compatibility) Requirements - IEC 60601 3rd edition Clause 1

A Quick Bump!

Can someone help?

Thank you very much!!

Stijloor.

Re: EMC (Electromagnetic Compatibility) Requirements - IEC 60601 3rd edition Clause 1

It's both.

Your risk management file shall address EMC related risks. If your environment is 'standard medical device environment', compliance with 60601-1-2 will probably sufficiently control your EMC risks and is your primary control measure.

If your device fits in the scope of IEC60601-1-2, the standard is normative and shall be used in conjunction with IEC60601-1 (see 1.3). You can use old EMC test data as long as you tested against the 3rd edition (2007) of IEC60601-1-2 (includes essential performance testing) and your design was not changed regarding EMC behavior.

Re: EMC (Electromagnetic Compatibility) Requirements - IEC 60601 3rd edition Clause 1

IEC 60601-1-2 is a standard based on set technical parameters which are supposed to represent the "normal" EMC environment. However, it does not cover special situations which may apply to an individual device.

Clause 17 of IEC 60601-1:2005 appears to be written in a way to be flexible to cover all real world situations.

For example, one very common situation not covered by IEC 60601-1-2 is electric field mains noise (50/60Hz). While there is a magnetic field test, many high impedance sensors or sensors in a floating circuit, (e.g. temperature probe in a Type BF circuit) the mains electric field will be more of a problem. For this, good CMRR and filtering is normally used to reduce the effect, but these functions are not tested in IEC 60601-1-2.

Another example: SpO2 probes can be sensitive to impedance sensing from ECG circuits (usually at 40-70kHz), again an issue not covered by IEC 60601-1-2. Equipment intended for use in MRI, or with HF surgical equipment might reasonably have issues outside of IEC 60601-1-2.

Other equipment might create special types of noise outside of the range of IEC 60601-1-2 emissions spectrum, which is nevertheless known to cause problems in other equipment.

That appears to be the point of Clause 17. A typical response would be to refer to IEC 60601-1-2 tests, and comment on whether the particular equipment is sensitive to or creates any special types of noise outside of IEC 60601-1-2.