Product safety certification for healthcare & other laboratory equipment continues to evolve. Thirteen months ago, on January 1, 2010, all new products and alternate constructions of listed or recognized products were required to be evaluated to UL 61010-1 2nd Edition.
The Second Edition combines 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.
On January 1, 2014, UL 61010A-1, UL 61010B-1 & UL 61010C-1 will be withdrawn, and all listed and recognized products must comply with UL 61010-1 2nd Edition.
Europe is on a different schedule. October 1, 2013 is the EU date of cessation for IEC 61010-1 2nd Edition. (IEC 61010-1 2nd Edition is aligned with UL 61010-1 2nd Edition, except for some U.S. national differences in the UL edition.)
IEC published the Third Edition of 61010-1 in June 2010. See the abstract here. Some of the major changes to the new edition include:
- Scope now covers both professional and non-professional products
- Test and measurement circuit requirements separated into a Part 2 standard: IEC 61010-2-30
- Reworked Clause 6.7 and added Annex K for clearances, creepages, solid and thin film insulation and molded and potted parts
- Temperature requirements modified due to EN563
- X-ray requirements modified to include intended and non-intended emissions
- New requirements for conformal coatings
- New requirements for risk assessment
- Added requirements for foreseeable misuse and ergonomics
The United States Technical Advisory Group (US TAG) and harmonization committee is working on the North American harmonized standards to IEC 61010-1 3rd Edition. They are completing the National Differences and plan to have the standard developed and issued by the Spring of 2012.
More on certification to UL/IEC 61010 & medical product certification to UL/IEC 60601.
7 Comments on Safety Certification to UL/IEC 61010-1 Evolves
Is the risk assessment referencing another standard or does the 61010 standard has its’ own unique risk assessment requirements?
IEC61010-1 Third has an Annex covering Risk Assessment. It is based on ISO/IEC Guide 51. It also references other standards containing risk assessments.
The risk assessment mentions several other standards that may be used. The actual content of Annex J (informative) borrows heavily from SEMI S10, on which I was an observing member. I do not know who the IEC committee member was who brought this reference to the 61010-1 committee.
You say, “On January 1, 2014, UL 61010A-1, UL 61010B-1 & UL 61010C-1 will be withdrawn, and all listed and recognized products must comply with UL 61010-1 2nd Edition.”
When must NRTL-certified products be compliant to the UL 3rd edition?
There is currently no mandate to use UL 61010-1 3rd edition or CSA C22.2 No. 61010-1 3rd edition; however, MET encourages their use for internationally marketed products.
If I have a product certified to 61010-1 ed.2 which sells in Europe, do I need to recertify it to ed.3 by Oct 2013? Or can this product still be sold in europe with ed.2 certification as long as its construction remains the same? Is there any time limit?
It is anticipated that all products shipped on or after October 1, 2013 must be declared compliant with EN 61010-1 3rd edition.
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