IEC 60601-1 3rd Edition adoption - I cant find this standard on the ISO page

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Bassman84

Dear Forum,

In my (young) regulatory department we are talking about which electrical safety standard to use, and its the 60601-1 standard. However, I am puzzled with the 3rd Edition publication. I cant find this standard on the ISO page, and wonder how I am meant to implement it if I cant find the thing.

We are working on ISO 14971 at the moment, is this the only significant change in the 3rd edition?

Thanks for any input on this...
 

Ronen E

Problem Solver
Moderator
Re: 60601-1 3rd Edition adoption

Dear Forum,

In my (young) regulatory department we are talking about which electrical safety standard to use, and its the 60601-1 standard. However, I am puzzled with the 3rd Edition publication. I cant find this standard on the ISO page, and wonder how I am meant to implement it if I cant find the thing.

We are working on ISO 14971 at the moment, is this the only significant change in the 3rd edition?

Thanks for any input on this...

Hello and welcome to the cove :bigwave:

You can purchase IEC 60601-1 3rd ed. here: http://webstore.iec.ch/webstore/webstore.nsf/Artnum_PK/35355

However, to "implement" it you'd probably also need the assistance of an accredited test lab that specializes in 60601.

Scroll down to the bottom of this page to find links to some very informative threads, discussing 60601 in general and the move to the 3rd ed. in particular.

Good luck,
Ronen.
 
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Bassman84

Hi Ronen,

Thanks for the quick reply. This site is really useful for these technical details eh:read:

Using an accredited 60601 third party will give us certification that the device (a centrifuge) meets the requirements of that standard then? This is together with the risk management sections of the revised electrical standard?
 

Ronen E

Problem Solver
Moderator
Hi Ronen,

Thanks for the quick reply. This site is really useful for these technical details eh:read:

Using an accredited 60601 third party will give us certification that the device (a centrifuge) meets the requirements of that standard then? This is together with the risk management sections of the revised electrical standard?

Yes, hopefully an accredited lab will provide such certification. I believe such certification shall also address the risk management aspects, but I'm not a 60601 expert. Hopefully some of those who are will join in soon. Try these threads blow, many of these aspects have already been discussed at length.

Please note that there is significant confusion surrounding the transition to the 3rd edition (this goes higher than "general public" level), and not many accredited labs currently offer (or are able to offer) 60601-1 3rd ed. certification.

Cheers,
Ronen.
 
B

Bassman84

Cheers Ronen,

Thanks for the reply.

We are discussing this now, so thanks for your input - I am also looking into other threads as you suggested.

Do you recommend buying the standards? Its a little difficult referring to standards if one doesn't know the contents of it. Does this go for other standards similarly? Is it required that I buy standards of other issues such as sterility - or is taking-their-word-for-it (the sterilising company) enough?

Vague eh... Im new to all this!
 

Ronen E

Problem Solver
Moderator
Cheers Ronen,

Thanks for the reply.

We are discussing this now, so thanks for your input - I am also looking into other threads as you suggested.

Do you recommend buying the standards? Its a little difficult referring to standards if one doesn't know the contents of it. Does this go for other standards similarly? Is it required that I buy standards of other issues such as sterility - or is taking-their-word-for-it (the sterilising company) enough?

Vague eh... Im new to all this!

Hi,

In general - yes, it's recommend to actually own legal copies of relevant standards, and yes, it's a bit tricky deciding which ones you need to buy... Perhaps you could browse them at an academic / public library nearby. Bottom line, it comes down to the number of standards of interest and their associated costs (which could be significant, take the 60601 series as an example). When it's only 2-3 standards and each costs up to several hundred $, I think it's best to just buy them.

Specifically - I strongly recommend you purchase the leading sterilization standards (e.g. ISO 11135, ISO 11137 etc.) applicable to the sterilization methods you utilize. While detailed, they are accessible to the normal intelligent person, and are quite useful even if you outsource your sterilization process(es). On the other hand, purchasing all applicable 60601-series standards may be too costly, and as you mentioned, not extremely practical. Instead, I recommend you contact an accredited lab who is dealing with 60601 certification. They will be able to guide you through this maze, and naturally they have legal copies of all such applicable standards.

Cheers,
Ronen.
 
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didsy

Hello Bassman84,

I am currently helping a few clients get their medical devices ready to be compliant with the 60601-1:2010 (3rd edition). Off the top of my head for devices being sold to the european market, they have to be 60601-1:2010 compliant by 2013, but for devices for sale in the USA they do not have to be complaint until 2018.

I am based in Switzerland and have a list of local accredited test labs that specialize in 60601 (amongst other things). You will find such labs where you are located.

What they normally require is;

a sample of the device (Including product label and all necessary markings)
schematics
a list of critical components
the user guide for the device
If the device contains electrical transformers, these have to be detailled
money
time (~4 to 6 Weeks for testing and reporting).

What you will received is a certificate and a test report.

If you want more detailled info let me know.

Hope this helps,
Didsy
 
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Bassman84

Hi Didsy,

Thanks for the feedback.
For a centrifuge machine, are relevant EMC provisions contained in this electrical safety standard?

I figured I will buy the standard and let the technical guys run with it. Are there specific subsections of this electrical standard that directly deal with centrifuges? I read that only the standards listed on the EC's 'Medical Device Standards' webpage are applicable to Medical Devices, though I cannot find a directly centrifuge-relevant standard. I guess its a matter of extrapolating centrifuge relevant parts of standards.

Thanks for any help on this!
p.s. I miss Switzerland, I lived in Sargans for a while and as a cyclist I had a great time!
 
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didsy

Hi Bassman84,

I think the 60601-1 refers out to EN61326-1:2006 (Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements), with specific requirements for in-vitro diagnostic equipment contained in EN61326-2-6, and transducers with integrated or remote signal conditioning covered by EN 61326-2-3.

I will look what we did last time for a client with a centrifuge and get back to you tomorrow.

PS Sargans is well positioned for Flumserberg - nice place.
 
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Watchwait

How does the fact that Switzerland is not in the EU impact 3rd Ed. requirements? Should they be considered that same as other EU countries, or not? I need some specific regulatory reference about Switzerland & 3rd Ed deadlines (or not!) to move forward with our comformance program... Thanks!
 
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