Laboratory equipment

UL offers product categories under UL 61010 that help you identify your laboratory equipment as either IVD equipment or suitable for health-care 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:

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 three 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 of which manufacturers should be aware:

• December 31, 2009 -- Last day manufacturers can submit products for Listing to the requirements in UL 61010A-1, UL 61010B-1, UL 61010C-1
• 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• January 1, 2014 -- UL 61010A-1, UL 61010B-1 and UL 61010C-1 will be withdrawn.

A copy of the Industry File Review bulletin is available at https://ifs.ul.com/ifr/ifr.nsf.

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 and 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.

The UL advantage

• UL has qualified engineers and testing facilities around the globe allowing you to work in your time zone and 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.

Additional resources

• Download information on UL's IECEE test services for lab equipment and medical devices