Laboratory equipment -- UL 61010-1 & IEC 61010-1

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 - 2^nd 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 2^nd 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 products under the scope of IEC/UL 61010-1 meet the requirements; however, there are other dates of which manufacturers should be aware:

• October 1, 2013 -- EU date of cessation for IEC 61010-1 2^nd edition. 
• January 1, 2014 -- UL 61010A-1, UL 61010B-1 and UL 61010C-1 will be withdrawn.
• June 1, 2014 -- All products that are in the scope of IEC61010-2-033 must comply with this standard and UL61010-1 3rd edition
• August 1, 2014 --  All products that are in the scope of IEC61010-2-091 must comply with this standard and UL61010-1 3rd edition.
• January 1, 2018 -- UL 61010-1 2nd edition will be withdrawn.

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

IEC 61010-1 3^rd edition

In June 2010, the IEC published the 3^rd edition of IEC 61010-1.  Some of the major changes to the new edition include:

• Test and measurement circuit requirements moved to a separate part 2 standard IEC 61010-2-30
• The scope now covers both professional and non-professional products.
• Rewritten clause 6.7 and added Annex K regarding clearances, creepages, solid and thin film insulation and molded and potted parts.
• More detailed mechanical requirements
• Temperature requirements modified due to EN563
• X-ray requirements modified to include intended and non-intended emissions
• Added requirements for foreseeable misuse and ergonomics
• New requirements for risk assessment
• New informative section on pollution degree and microenvironments
• New requirements for conformal coatings
• New informative section explaining how to determine the working voltage of a mains circuit

As mentioned above, the EU has established the date of cessation for the 2^nd edition as October 1, 2013, which means by that date, all new products under the scope of IEC 61010 being sold in the EU must demonstrate conformity to the 3^rd edition of IEC 61010. 

As of May 11, 2012, the United States Technical Advisory Group (US TAG) and harmonization committee published the North American harmonized standards to IEC 61010 3^rd edition. 

Also, two new IEC61010 part 2 standards have been published: IEC61010-2-033, Particular requirements for HAND-HELD MULTIMETERS and other METERS, for domestic and professional use, capable of measuring MAINS voltage and IEC61010-2-091 : Particular requirements for cabinet X-ray systems. These have been adopted as EN standards.

UL Knowlege Services offers training on designing for compliance to the 3^rd edition.  See the "Additional resources" section below for more information and to register.

Laboratory Equipment for Healthcare Applications

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:

UL Services for Laboratory Equipment

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
• Certification - also known as Listing and/or 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.  See the latest updates on UL's 61010 blog at www.ul.com/61010blog
• 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

• Article: "IEC61010 3rd edition: New international safety requirements for lab equipment", Test & Measurement World (2013)
• IEC 61010 2nd to 3rd edition Correlation reference guide - 20 pages including IEC 61010-2-030  (Registration Required)
• Learn more:  Register for UL Knowledge Services IEC 61010 workshop on designing to IEC / UL 61010 3rd edition
• 30-Minute On Demand Webinar:  "The National Differences Between UL 61010-1, UL 61010-2-30 and the IEC 61010-1 Standards"