Medical Devices

Lab Equipment

UL offers product categories under UL 61010 that help you identify your laboratory equipment as either IVD equipment or suitable for Healthcare applications such as hospitals, clinics, outpatient facilities and medical laboratories. These product categories are easy to identify and help hospital purchasers, auditors, regulators and biomedical technicians show compliance to the applicable standards. They are:

1. OGUR - "Laboratory In Vitro Diagnostic Electrical Equipment"
2. OGUI - "Laboratory Electrical Equipment for Use in Health Care Applications"

What does UL 61010-1 cover?

The scope of UL 61010 encompasses both laboratory equipment covered in Healthcare applications and equipment covered under other industrial applications. Published on July 12, 2004, UL 61010 Part 1 - 2nd Edition combined the 3 previous UL standards UL 61010A-1 for laboratory equipment, UL 61010B-1 for test and measurement equipment and UL 61010C-1 for process control equipment into a single standard. UL 61010-1 2nd Edition is completely aligned with the current edition of IEC 61010-1, except for some U.S. National Differences. Since the effective date for this standard is January 1, 2014, there is still time to make sure your products meet the requirements; however, there are other dates manufacturers should be aware of:

• January 1, 2008 - UL 1244 (Electrical and Electronic Measuring & Testing Equipment) will be withdrawn.
• January 1, 2010 - All new products and alternate constructions are evaluated to UL 61010-1. Existing products retain their listings.
• January 1, 2014 - UL 61010A-1, UL 61010B-1 and UL 61010C-1 will be withdrawn.

With one set of tests and one audit to meet regulatory quality requirements for IVD equipment, UL offers end-to-end regulatory and certification services for Laboratory Equipment manufacturers seeking global market access. These services include:

• Technical training for design to 61010 Requirements
• Preliminary Design Construction Review - to identify safety prior to ordering parts
• Evaluation to the IVD Particular Standard 61010-2-101
• IVD Directive Notified Body for the European Union
• International certification for market access
• CB Reports and Certificates
• Listing, Classification to UL 61010
• EMC Testing & Pre-scans
• Quality Management System Registration
• Hazardous Environment testing
• Homeland Security applications. UL 61010-1 is the safety standard used for inspection type HS equipment such as Baggage Scanners, metal detectors and similar equipment.

Benefits of UL's 61010 Services

• UL has qualified engineers and testing facilities around the globe allowing you to work in your time zone & local language to access global markets.
• Integrated services - UL provides complete regulatory & certification services for laboratory equipment manufacturers.
• Expertise and Representation - UL is a member of TC 66 and sits on the IEC Standard Committee.
• UL now provides 'one stop shopping' for your certification needs. One submittal can get you the UL mark and CB certification for worldwide acceptance of your product.

FAQ

Q1: Why did UL create new Product Categories (CCNs)?

A1: UL is responding to an industry request by Laboratory equipment manufacturers working in the highly regulated healthcare industry to further distinguish their laboratory equipment as suitable for use in healthcare 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

Q2: I am an existing client and only want to transfer a part of my file. How do I do so? A2: 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 # in a different CCN at each location so this may impact your FUS fees.

Q3: Are these CCNs being created to address changes in the standard?

A3: There have been no changes to the standard - UL 61010. These CCNs have been created in response to industry and healthcare regulators requiring distinction between UL 61010 equipment and laboratory equipment for use in healthcare applications.

Q4: Where can I find information on the new CCNs?

A4: UL's Online Certifications Directory contains the guide information.

Q5: What if a device falls under both healthcare and non-healthcare categories and I want to maintain both?

A5: 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.

Q6: What if I'm not sure what category (OGUI or OGUR) to place a device under? (i.e. a centrifuge)

A6: The decision is based on function. If the centrifuge is spinning human fluids, it would have to be OGUR.

Q7: What if my device has not been evaluated to 61010-2-101?

A7: It can't be transferred to OGUR. OGUR is In vitro diagnostic equipment, which needs the -101 standard.

Q8: How long do I have to transfer my models free of charge?

A8: Through March 31, 2008, you can transfer your existing qualified UL 61010 products from OGTK to the appropriate category for healthcare or IVD equipment free of charge.