Laboratory equipment FAQ
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Why did UL create new product categories (CCNs)?
UL is responding to an industry request by laboratory equipment manufacturers working in the highly regulated health-care industry to further distinguish their laboratory equipment as suitable for use in health-care applications and for In Vitro Diagnostic applications. These new CCNs are:
- Laboratory In Vitro Diagnostic Electrical Equipment (OGUR)
- Laboratory Electrical Equipment for Use in Health Care Applications (OGUI)
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I am an existing client and only want to transfer a part of my file. How do I do so?
Please contact your local customer service team and request a partial transfer. Note: your manufacturing location will be charged a FUS fee for each discrete model number in a different CCN at each location, so this may affect your FUS fees.
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Are these CCNs being created to address changes in the standard?
There have been no changes to the standard, UL 61010. These CCNs have been created in response to industry and health-care regulators requiring distinction between UL 61010 equipment and laboratory equipment for use in health-care applications.
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Where can I find information on the new CCNs?
UL's online certifications directory contains the guide information.
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What if a device falls under both health-care and non-health-care categories and I want to maintain both?
As long as the product meets all applicable requirements, we can offer a complementary listing to both applicable product categories (OGTK and either OGUI or OGUR, depending on application). There is only one FUS fee for products under a complementary listing.
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What if I'm not sure what category (OGUI or OGUR) to place a device under, for example, a centrifuge?
The decision is based on function. If the centrifuge is spinning human fluids, it would have to be OGUR.
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What if my device has not been evaluated to 61010-2-101?
It can't be transferred to OGUR. OGUR is In vitro diagnostic equipment, which needs the -101 standard.
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