This message was posted by a user wishing to remain anonymous
Thank you all for your answers. Our device uses a Power Supply Adapter with these specs:
Input 100-240 VAC, 50-60 Hz, 1.4-0.7 A s
output: 24 VDC; 2.5 A; 60 W
The low voltage directive is actually another source of confusion for me, as it applies to electrical equipment with a voltage range of 50-1000 V AC and 75-1500 V DC. Should I look at the input or the output of my device? I assume it is about the output, which means that the low-voltage directive should not apply to us.
The product will never be in contact with patients and is not in contact with other equipment. It is used by healthcare practitioners and can be in labs where there is other medical equipment (that's why EMC and radio-frequency apply).
Regarding OSHA, the funny thing is that I just call their helpdesk and they told me that there are no requirements for manufacturers as they only handle end-users. They did not know whether we need to have NRTL testing and registered certification. Also it seems that there is a specific list of items that need to have NRTL registration. See
https://www.osha.gov/dts/otpca/nrtl/prodcatg.htmlMaybe this is why we don't need NRTL?
Please let me know your thoughts.
Thank you very much for all your precious feedback
Original Message:
Sent: 22-May-2019 16:45
From: Anonymous Member
Subject: IEC 61326 and 61010-1 - laboratory use
This message was posted by a user wishing to remain anonymous
Yes, 60950 applies to more things than you would think, because it's really not about the data, it's about the electrical safety of the equipment.
Both series (61010 and 60950) are harmonized under the Low Voltage Directive.
How much power does your product use? Is it in contact with people? Does it connect to other equipment? Does it get wet?
In my (very limited) experience, hospitals expect UL or ETL listing for any equipment they bring in.
And NRTLs have lots of experience recommending applicable standards.
Original Message:
Sent: 22-May-2019 10:54
From: Anonymous Member
Subject: IEC 61326 and 61010-1 - laboratory use
This message was posted by a user wishing to remain anonymous
Thank you Michelle. This is very helpful. I was indeed planning to go though all the directives you mentioned.
Still don't have clear though why you would recommend IEC 60950 rather than 61010.
Just to clarify more, this tool is a sort of simulator that can be used by doctors for hands-on practice. When I think about IT equipment I think more about systems to store/process/transfer data, so something different from what our product does.
I also wonder if we should take into account OSHA as well for USA and whether a NRTL certificate is required.
Thanks
Original Message:
Sent: 20-May-2019 15:20
From: Michelle Comas
Subject: IEC 61326 and 61010-1 - laboratory use
Hi
You may want to consider IEC 60950 rather than 61010.
With the device having Bluetooth communication you may want to consider how the Bluetooth is regulated in the U.S.and EU. Most Bluetooth technology runs on 2.4GHZ RF which may trigger regulatory approval.
In the U.S., the FCC is the certifying body. Also check the Bluetooth Special Interest Group (Bluetooth SIG).
In the EU, The radio equipment directive 2014/53/EU (RED) establishes a regulatory framework for placing radio equipment on the market.
With electrical and electronic equipment, the Restriction of Hazardous Substances Directive 2002/95/EC also applies. As does the European Union Regulation (EC) 1907/2006 concerning the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) as "ARTICLES"
When marketing in the EU, I have found referencing the 'Blue Guide' to be most helpful. The latest version of the Blue Guide can be found via http://ec.europa.eu/growth/single-market/goods/index_en.htm
------------------------------
Michelle Comas
RAPS Utah Chapter
Global Product Compliance Manager
Salt Lake City UT
United States
Original Message:
Sent: 15-May-2019 05:32
From: Anonymous Member
Subject: IEC 61326 and 61010-1 - laboratory use
This message was posted by a user wishing to remain anonymous
Hi,
I have been always working in the medical device industry and now for the first time, I found myself dealing with "general products" regulations. We are trying to market a product to be used for the education of junior medical surgeons and students. The device has an electrical component and a bluetooth but it is never in contact with the patient. The device can be used anywhere including sometimes in the hospital labs where there may be other medical electrical equipment.
I do not have completely clear whether we should consider our product an electrical equipment for lab use and use IEC 61326 for EMC and IEC 61010-1 for electrical safety.
These standards define lab equipment as equipment that is used for measuring, recording, controlling, monitoring, analyzing, etc., while our device is only a tool used to educate doctors and students.
Also, is there any other standard which I should consider for this type of device? I am interested in both the European and American market.
Any insight on this would be highly appreciated. Thank you very much