IEC 60601 Clause 57.3 / 8.11.3.2 - PVC Flexible Cords

phase90

Involved In Discussions
#1
I am going through 601 and I am having a bit of an issue with clause 57.3 (2 nd edition) and 8.11.3.2 (3rd edition) regarding cord types. Do cord sets need to be certified to UL 227 or just use a robust PVC? The cord we are using is a hospital grade cord (green dot and all) that uses UL listed connectors at both ends and UL listed cord. The manufacturer says the cords are made in compliance with UL 817.
Do the two tie together (817 and 227)?
 
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raymond02302

#2
Re: Clause 57.3 / 8.11.3.2 - PVC

IEC 60601 is the international standard for medical equipment. Since IEC issues the standards for flexible cable (IEC 60227 for PVC jacket and IEC 60245 for rubber jacket),IEC 60601-1 specifies requirement flexible should be certified to relevant standards (IEC 60227 or IEC 60245).
Based on national deviation, UL 60601-1 corresponding to IEC 60601-1 2nd edition specify its own requirment for flexible cable (UL 62) or cord set(UL 817).
When you apply an NRTL mark such as UL,ETL,CSA etc, The cord set should be certified to UL 817.
 

phase90

Involved In Discussions
#4
Re: Clause 57.3 / 8.11.3.2 - PVC

Thank you for your quick response.
I am looking at UL 60601-1 (2nd edition), clause 57.3b (types). It also refers to IEC 227 designation 53. (the ANSI AAMI 3rd edition, clause 8.11.3.2 also refers to IEC 60227, Annex A, designation 53). I do not see where it refers to UL817. Where is this deviation? The only place that I found UL 817 is in Annex DVA where it just says cord sets UL817.
If a cord set is certified to UL817, does that mean that it is robust enough to satisify the conditions of UL 227 / IEC 60227?

Thanks.
 

Peter Selvey

Leader
Super Moderator
#5
Power cables (cords and plugs) are normally covered by separate regulations in each country. Thus, it really does not matter what IEC 60601-1 says, you need to comply with those power cord regulations.

Fortunately, most suppliers of cord sets know these regulations well, so if you buy a cord set with a US plug, it will comply with US regulations. If you buy one with an Australian plug, it will comply with Australian regulations. And if you want to be sure, contact the supplier of the cord set.

Also note that it is possible to argue that in IEC 60601-1, for equipment that uses a detachable cord set, the cord set itself is not part of the "medical electrical equipment".

This is based on 57.3 which says that "EQUIPMENT ... shall be provided with either a POWER SUPPLY CORD or an APPLIANCE INLET".

So, if the equipment has an appliance inlet (for a detachable cord), then the power supply cord is not part of the equipment. This makes sense since of course in the real world it can be used with any detachable cord set.
 
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