IEC 60601-1-2 & 60601-1-11- Acceptance Levels

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Lucy Jordan

Hi All,

It has been recommended that we test our device, a contact lens case with a battery used in the indicator for disinfection, for its electromagnetic compatibility (EMC) in accordance with 60601-1-2, Medical Electric Equipment Part 1; General Requirements for Safety, Electromagnetic Compatibility (Requirements and Tests). In addition, it was suggested that we review 60601-1-11:2010 Home Healthcare Equipment.

Since we do not own either of these documents and as a small company, do not want to purchase them if not required, I was hoping that someone may know a bit about them:

Does 60602-1-2 provide acceptable criteria for EMC? It would seem so, but then, it would also seem that his would differ depending upon the device being tested?
What are the relevant tests listed in 60601-1-11:2010 that may be applicable for a contact lens case, and again, are acceptable levels provided?
Thanks for any guidance/thoughts that you can provide.

Lucy
:thanx:
 

Mark Meer

Trusted Information Resource
Hi Lucy,

Re: 60601-1-2
You are correct in your assumption that the requirements differ depending on the device and its intended use...
In my opinion, as a small company, you'd be best to consult with a reputable test-lab to assess the requirements according to your device, and perhaps perform a prescan to see if you have any issues...
The reasons being not so much that the standard is expensive (as you point out), but that it, in turn, refers to a whole bunch of other "Normative references" (other standards). To get a full picture, you need a lot of technical expertise as well as in-house equipment (specific acceptable levels doesn't help much if you don't have way to test it yourself). ...unless you have such resources, this is best left to a 3rd-party, IMHO.

As for 60601-1-11:
Again, dependent on device and use: mains powered? replaceable battery? transport-operable?...
Likely you've considered most of the requirements as part of design/risk-management, but it wouldn't hurt to have a copy just to be sure... Things like:
- Can the instructions be understood by a lay-person?
- Can the device withstand conditions that might be expected? (e.g. thermal shock, dropping/impact, transport...)
The specifics, of course, are in the standard.... Might recommend getting a copy if your company makes devices intended for home-use...
 
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Lucy Jordan

Hi Mark,
Thanks so much for your response, I did not really expect an easy answer, but you confirmed my thought that we do not have the expertise here to make the assessment!
Lucy
 
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