Current standard references IEC 60601:1988 instead of current version

[milagre]

I am trying to go through each subclause of EN ISO 8185 right now to ensure we are compliant with it. It continually references IEC 60601-1:1988, which I don't have a copy of (we only keep a copy of the newest 60601-1).

I am finding it hard reading 8185 because I don't always understand what sections of 60601-1 it is referring to and modifying. Anyone else dealt with this problem before? Any advice? I'd really rather not buy a 1988 version of 60601-1.

 

[SteveK]

I sympathise with your problem. I have to comply with ISO 8185 also; however our device is a simple (passive) bubble humidifier so IEC 60601-1 clauses do not come into play, only a limited number of clauses in ISO 8185 do in fact apply for compliance purposes. This problem with the 1988 version of IEC 60601-1 comes into play with another standard which is an issue for me i.e. ISO 10079-1 (for Electrical Suction Devices), which references its clauses similarly throughout. We are developing a new device which needs to comply with this (equally messy) standard. Whoever developed and approved these standards referencing IEC 60601-1:1988 in the past were totally lazy b*%$£?ds in my opinion. I my case I do have a copy of IEC 60601-1:1988 (IEC 601-1:1988) but it does not really help as we would not be able to conduct the tests etc. referenced in-house (by the way I archive copies of all old standards). I am hoping that the new draft (DIS) ISO 10079-1 will be published as a full standard soon, as this removes any reference to IEC 60601-1:1988 and we would be able to conduct all the tests required in-house. Similarly ISO 8185 is being replaced by - ISO 80601-2-74 “Medical Electrical Equipment Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment”. Again this removes any reference to 60601-1:1988 but is also only at the DIS stage. Incidentally this DIS standard does not include bubble humidifiers! There is now a new separate standard for passive humidifiers but this is only at the WD stage at present. Ultimately in the past when we have had to show compliance with a standard which references IEC 60601-1:1988 clauses, we have relied on a test house and their certification. Sorry about not being too helpful.

Steve

 

[SteveK]

Correction!

Just checked my Bubble Humidifier Product Dossier and a number of clauses (referenced in ISO 8185) from IEC 60601-1:1988 do in fact apply!

Steve

 

[milagre]

Thanks for all the info Steve. At least I'm not the only one frustrated by this.

 

[Marcelo]

I see the following options:

- use the harmonized standard and related second edition of IEC 60601 - this is the most straightforward and you keep the presumption of conformity

- use the harmonized standard, but instead of using the second edition of IEC 60601, use the third edition. This would require analysis of which related clauses of third edition applies. But although possible, it?s generally not expected that editions are mixed.

- use the revision of ISO 8185, ISO 80601-2-74 Ed. 1.0
Medical Electrical Equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment. This would be the better solution, however ISO 80601-2-74 is still in the CDV stage of the drafting process. If it was at least in DIDS, its use could be readily accepted in principle, but on CDV, it?s more difficult.

So it does seem that the first option is really the best at the moment.

 

[Pads38]

What may help to get a basic understanding of what the referenced 1988 clauses refer to is the IEC Technical Report 62348 which maps the clauses to the equivalent clauses in edition 3.

The 2006 version (since superseded) is available [FREE!] here:
https://webstore.iec.ch/publication/20459

(The 2012 version adds information on Amd. 1 but costs 300SFr).