The Korea Ministry of Food and Drug Safety (MFDS) recognizes IEC 60601-1 (Ed. 3.1). Now that IEC 60601-1 (Ed. 3.1) had been amended, the Korea MFDS amended the ‘Common Specification for Electrical Safety of Medical Device’ for international harmonization of standards. The main amendments are as follows:
1. Reduced number of items that require risk management file analysis:
Some of the standard tests had previously required a risk assessment in the risk management file in order to make the decision on whether or not it should be considered. MFDS reduced the number of tests that require risk management file analysis from 126 to 88 items.
2. Terms and Definitions: MFDS clarified ambiguous terms and established new definitions for the terms that needed new ones such as alarm systems, body-worn, etc.
3. Clearer requirements: MFDS mitigated the requirements for certain tests including the tests included in the safety review such as instability tests for mobile medical device. Also, they also clarified the contact part of the device is determined by the risk management file, which makes the regulation clearer than the criteria specified in IEC 60601-1:2005.
4. Transition: If the technical documents for registration are submitted before the required transition to IEC 60601-1 (Ed. 3.1), MFDS will apply the previous standard, IEC 60601-1, Ed. 3.0. After the enforcement of IEC 60601-1 3.1 edition (2015.12.31), the 3.1 edition will be applied to new registrations. However, for submission requests and technical document review requests received before the enforcement of Ed. 3.1, the previous version 3.0 will be applied.
1. Date: December 31st, 2015 (Class II: 1 January, 2016, Class I: 1 July, 2016)
2. Grace Period: Until 31 December, 2017
3. Parallel Period*: Until 31 December, 2017
* IEC 60601-1 Ed. 3.0 and 3.1
For imported products, some other countries have not transitioned to IEC 60601-1 (Ed. 3.1) yet. In order to register the product in Korea, the manufacturer would need to conduct the testing to IEC 60601-1 Ed. 3.1. Therefore MFDS provides a grace period until the other countries transition to IEC 60601-1 Ed. 3.1.
∙ Application of main countries: EU, Canada (January 2018), USA (August 2016), Brazil (September 2015)
With reduced burden of applying risk management analysis, IEC 60601-1 (Ed.3.1) tends to be more straight forward when compared to Ed.3.0. However, the new edition now requires a usability (HFE) test report, so manufactures should take advantage of the grace period to prepare.
UL provides the following service in order to fulfill the regulatory requirements.
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[UL Solutions Team]
Usability Documentation Service
Gap analysis to IEC 60601-1 ed. 3.0 and 3.1
[UL’ s HFE practice, formerly Wiklund R&D, USA]
Program Development Support: Refining human factors engineering programs that will satisfy global HFE requirements
User Research: Observations, user interviews and benchmark usability tests
Analysis: Function, task, and use-related risk analysis
User Interface Analysis: Assessment of software and hardware user interfaces, as well as accompanying documents (e.g., user manuals, quick reference guides)
Evaluation: Critiques of evolving design solutions and both formative and summative, usability testing, etc.
Training: Private and public Technical talks and workshops