Partner with UL Technical Experts during your Transition to IEC 60601 3rd edition
Wherever in the world you are selling medical devices, a test report from UL carries with it the advantage of recognition. UL technical experts serve on the International Technical Committees that developed IEC 60601-1 3rd edition, so when you work with UL through the transition, you gain the advantage of working with the global leaders in IEC 60601-1 3rd edition knowledge.
"When Elliquence first started our IEC 60601 3rd edition update project, we struggled to find a test lab that would help us achieve our goals and not repeat the mistakes of the past. Other test labs employed produced nothing more than disappointment at the very least and tremendous frustration in the lack of knowledge, professionalism, project management abilities and test planning. Doing business with these labs was a nightmare to say the least. We never achieved our goals in the way we planned and the project was never completed on time, if completed at all. So we entered into this project with ridged backs expecting the worst, but to our delighted surprise we got the best in UL services." -QA Department, Elliquence, LLC
Transition Dates - IEC 60601 3rd edition
European Union (EU) General Standard
June 1, 2012
European Union (EU) Particular Standards
Canada General Standard
June 1, 2012
Canada Particular Standards
United States of America (FDA)
July 1, 2013
*Will accept 2nd edition, extended through Dec. 31, 2013
Jan. 1, 2014
Published June 1, 2012 *(Transition potentially 2017)
Recognize 3rd Edition, no transition date announced
June 1, 2014: Classes 3 & 4 + 53 Particular Products
June 1, 2015 - Class 2 + 58 Particular Products
June 1, 2016 - Class 1 + 50 Particular Products
*Medical devices that fall within the scope of a particular standard are subject to various dates as noted by the Official Journal of the EU for EU and for Canada, a 3 year transition from the date of publication of the particular standard.
August 2013 - FDA Announces extension of transition deadline to 3rd edition, accepting 2nd edition reports through Dec. 31, 2013.
July 2012 - Amendment 1 of IEC 60601 3rd edition passes vote - see UL's 60601 blog page for more details
June 2012 - JIS T 060606-1: 2012, the Japan version of IEC 60601 3rd edtiion has been published as of June 1.
- March 2012 - Health Canada sent a letter to manufacturers applying for Canadian medical device license clarifying the approach for devices with and without particular standards since not all particular standards have been harmonized with the 3rd edition of IEC 60601. It also clarified that compliance with 60601-1-9 is not a requirement for licensing.
- February 2012 - NB-MED issued first draft of "Frequently Asked Questions related to the Implementation of EN 60601-1:2006 with respect to MDD 93/42/EEC"
3rd edition tools:
- Transfer your medical certification to UL, re-testing may not be required
- The ISO 14971 Risk Management Toolbox is now for sale. Ask for more information - Email: Medical.Inquiry@ul.com
- See how prepared you are for the transition to IEC 60601 3rd edition. Try our new online self-assessment tool and download a custom report.
- Are you ready for ISO 14971? Download the ISO 14971 checklist to find out.
IEC 60601-1 3rd edition resources
White Papers, Case Studies & Articles
Complementary with Registration
- White Paper: "Choices - IEC 60601-1 3rd Edition and Component Selection"
- Article "IEC 60601 and Risk Management", Medical Electronics Design (2011)
- Article: "Auditory Alarm Requirements in IEC 60601-1-8 and Risk Management Considerations", Med-Tech Innovation (2011)
- Article: 60601-1 Third Edition: Why Management Should Consider Converting Now
- Q&A with UL: IEC 60601 3rd edition, Release 2, includes specific information on using Power Supplies in 3rd edition end products
- White Paper: Home Healthcare Equipment: An Overview
- Industry Report: A Review of Market Entry Requirements for Risk Management, with Special Emphasis on FDA and ISO 14971 Compliance.
- Industry Report: Risk Management and Post-Market Surveillance: FDA Considerations
- Industry Report: Major Regulatory Decisions on the Third Edition of IEC 60601-1 (The 3rd Edition Update: 2010)
- Industry Report: The 3rd Edition Update: 2008
- Industry Report: The 3rd Edition Update: 2007
- Article: "A New Perspective on Medical Devices Certification", MD&DI
- Article: "Regulatory Strategies for the Third Edition of IEC 60601-1", MD&DI
- Article: "IEC 60601-1 The Third Edition", Kindly reprinted with permission from the Journal of Medical Device Regulation
- Case Study: Siemens Magnet Technology Ltd. - ISO 14971 used in IEC 60601 3rd edition
- White Paper: Major Regulatory Decisions on the Third Edition of IEC 60601 (2008)
Useful 3rd edition links (external):
- Link to Japan MHLW web page where JIS T 060601-1:2012 may be acquired (Japan language)
- Link to purchase IEC 60601 Amendment 1 (U.S. DRAFT Version)
- Link to free published document IEC 62348 "Mapping between the clauses of the third edition of IEC 60601-1 and the 1998 edition as amended"
- *NEW 2nd Edition* "Guidance for the Evaluation of Risk Management in Medical Electrical Equipment" - OD-2044-ED.2.0 covers the use of Risk Management for all medical electrical devices, including power supplies.
- Click here for link to IECEE table showing "Use of collateral standards in the IECEE system for 2nd and 3rd Editions of IEC 60601-1" including Biocompatibility
- Status of the publication and recognition of particular standards in the EU on the CENELEC website.
- Purchase IEC 60601-1:2005
- Purchase ANSI/AAMI ES 60601
UL webpages for 60601 collateral and particular standards:
- IEC UL 60601-1 - General Standard, includes 2nd edition
- IEC 60601-1-2 - EMC
- IEC 60601-1 - Software includes 60601-1-4 2nd edition
- IEC 60601-1-6 - Usability and Human Factors
- IEC 60601-1-11 - Home Healthcare Equipment
- IEC 60601-2-24 - Infusion Pumps
- ISO 14971 - Risk Management
Contact UL Health Sciences about 60601 3rd edition:
- Contact us - www.ul.com/contact
- Email: Medical.Inquiry@ul.com
- Request a Quote: HealthSciencesNA@ul.com
- See how UL can support you throughout the product lifecycle: www.ul.com/medical/movie