1 January 2019 is not far away and the 4th edition of the standard may have a significant impact on the design, testing and documentation of many medical devices that have not met this standard yet.  For the US (FDA), EU (CE Mark for Medical Devices), and Canada (Health Canada) this is the final transition date to meet this requirement.

When do we have to comply with IEC 60601-1-2 4^th edition?
The three countries/regions of the world (US, EU, & Canada) have synchronized the date of compliance to 1 January 2019.  This was not always the case as FDA modified their transition date several times before settling on this date.  Realize that most other countries are requiring 3rd edition and some are still back on 2nd edition of IEC 60601-1-2.  A brief summary by region is shown below:

USA – For new submissions to the FDA, compliance to the 4^th edition will be mandatory by January 1, 2019. The FDA now recognizes the 4^th edition and encourages manufactures to comply with the 4^th edition for new device submittals and this can be seen in the updated Final Guidance for Home Use Medical Devices that the FDA re-issued in November 24, 2014 and updated on August 8, 2016 to update the transition date of ANSI/AAMI/IEC 60601-1-2. During this transition period the FDA also will accept 3^rd edition of the standard as well up til December 31, 2018.

European Union – The Date of Withdrawal (DOW) which is the required compliance date of EN 60601-1-2:2014, is December 31, 2018.  The DOW date is the end of the grand fathering period for the previous version of the standard, EN 60601-1-2007 (third edition).  After that date, all devices including legacy devices sold to the EU must comply with the new standard.

Canada – In Health Canada’s List of Recognized Standards it states that until December 31, 2018 it will accept Declarations of Conformity to either 3rd or 4th edition of IEC 60601-1-2.  After which declarations of conformity to IEC 60601-1-2:2007 – Ed 3.0 will not be accepted.

Other Regions – The compliance dates are highly variable driven by other international standards and local regulations. For example, for a particular standard (Part 2 particular standards IEC 60601-2-XX or IEC/ISO 80601-2-XX) for a given device will most likely at this time reference IEC 60601-1-2, 4th edition if the country is using the most current IEC 60601-2-XX or IEC/ISO 80601-2-XX standard but otherwise may be referring to an older version of the IEC 60601-1-2.   Additionally, some countries will NOT accept the 4th edition at this time to further complicate this issue.

Please note that compliance dates of standards are driven by their national regulatory bodies (i.e. US = FDA, Canada = Health Canada, etc.) and are subject to change.

It is strongly recommended to comply with the requirements of IEC 60601-1-2 4^th edition for all new medical device designs going into the US, EU, and Canada.  You may still need to meet 3^rd edition, as well.  It really depends on what other countries you plan to sell too and your regulatory strategy.  We can help put a test plan and test strategy together to deal with testing to 3rd & 4th edition.

We have several EMC experts that can assist our clients with the transition to IEC 60601-1-2, 4^th edition as it is having a major impact on the design, testing and documentation required of most medical devices.  We are seeing signs of a new wave of projects related to IEC 60601-1-2, 4^th ed. and know that this edition will have a big impact on electrical medical devices.

The EMC services we can provide your medical device company are listed below, for your convenience, in addition to our other regulatory, product safety, engineering, and quality system consulting services.

EMC Services Available

• EMC Design – Review of PCB schematics & layouts, enclosure design, mechanical construction, internal and external cabling design, etc.
• Mitigations  – Problem analysis, prototype fixes, support design engineering on redesigns, EMC component vendor liaison, etc.
• EMC Witness Testing & Documentation – Perform testing oversight, generate test plans, review and generate test reports
  
• Risk Analysis – Work with the design and test teams to address Risk Management as required by IEC 60601-1-2 4^th edition
• EMC Standards – Guidance and interpretation of numerous EMC standards and regulations
• EMC Regulatory Engagement & Support – Provide support for FDA, FCC, Health Canada, KFDA, ANVISA, CE Mark and other agency approvals
• Medical Device EMC Labeling – Review accompanying documents for compliance to IEC/EN 60601-1-2 requirements
  
• Training – Training your staff on EMC design, testing, IEC 60601-1-2, 4^th edition, and differences between 3^rd and 4^th editions

Are you ready for these changes, do you have the bandwidth to deal with these changes?  We can help you with preparing for these changes and on your EMC regulatory strategy. Contact us at Leo at EisnerSafety dot com or call Leo at 503-245-6558 to arrange an EMC project to help support your medical electrical device EMC needs.