Is 60601-1 mandatory for ALL medical devices ?

Hi There,

Is 60601-1 mandatory for all medical devices or does it depend on the classification/category. The company I work for is currently working on a medical device (classification code "ILY") that will be offered for sale in Canada and the US.

We will be submitting a 510(k) shortly but only have passed the device through standard CSA electrical testing & 60601-2 (EMC) test. Would 60601-1 be required as well?

 

Usually, no standard is mandatory (they are mandatory only in certain very specific countries such as Brazil, China and Korea). But you may use standards to show compliance with mandatory regulatory requirements.

IEC 60601 is applicable to all medical electrical equipment (not all medical devices). You may use it to show compliance with several regulatory requirements.

The "electrical testing" you mentioned is probably IEC 60601.

 

Thanks for the response.

Our device is an electrical equipment therefore I guess we will require 60601. The current electrical certification we have with CSA is not for medial equipment.

 

Hi,

The FDA code ILY comes under class II, and it has a "special control" guidance document (relating to the preparation of a 510(k) submission under this code). This guidance document doesn't mention or hint that 60601-1 certification is required. Obviously there might be safety aspects in the submission that could benefit from such certification, but apparently it's not mandatory. The above guidance document is quite old, but apparently that's still the FDA's reference for that code.

I'm not familiar enough with the Canadian system to comment in that context.

Cheers,
Ronen.

 

I made a post the other day, that may be worth considering:
http://www.qualityforumonline.com/f...-program-make-60601-compliance-mandatory.404/

Basically, if you intend to market your device to clinics, hospitals, or any other establishments that abide by OSHA, then you'll likely have to have an NRTL mark on the labelling.
...and this means that yes, testing to AAMI ES60601-1:2005/(R)2012 by an accredited NRTL will be required.

 

Surprisingly Canada is in effect a requirement, although it is state based, not federal. If the local state laws have adopted the Canadian Electrical Code (CEC), it is required to have the devices certified by a recognized agency. However, there are arguments that the scope can be limited to electrical safety issues. Nevertheless, the agency testing the product will probably insist to include a wider scope according to their internal policy.

The OSHA/NRTL scheme is as mentioned above, not law but effectively required to sell to major facilities through purchasing requirements. As for the CEC, the raw scheme is fairly limited in scope (worker safety), but the test/certification agency will probably insist on a wider scope anyway, at least as wide as what they can do, and then conveniently exclude the stuff they can't.

In my opinion, a simple reasonable cost scheme which focuses on basic electrical/mech/fire/thermal issues should be created, to avoid the high cost associated with getting 3rd party testing to full scope of modern medical standards, which is extremely wide.

 

Totally agreed. As far as I'm aware, OSHA's mandate is to protect workers and establish standards for workplace safety. Ideally, their criteria would be a sub-set of an established safety standard, so that their requirements only deal with workplace safety.

In the case of getting medical-devices OSHA/NRTL marked, the fact that you have to demonstrate patient safety, as per the medical requirements of 60601-1 to get the mark, to me reeks of mission creep.

If they want to stick with an established standard (e.g. IEC 60601-1), the least they could do is narrow the scope to exclude all the clauses unrelated to workplace hazards.