This is a summary of some of the changes in EMC requirements of IEC 60601-1-2, 4^th ed. & a discussion of timing of requirements in different world regions.

Darryl Ray, of Darryl Ray EMC Consulting, provided the technical and regulatory content for this Blog Post.  Thx for your insight Darryl!

What is the impact of switching to IEC 60601-1-2, 4^th edition on your electrical medical device?  A partial listing is noted here:

• EMC must be addressed in the Risk Management documentation
• A test plan & report are required and the minimum contents specified
• Immunity levels are based on use location (not the device type). The use locations are: 1) Professional Healthcare 2) Home Healthcare 3) Special
• Radiated Immunity levels vary depending on use location
• Radiated Immunity upper test frequency is now 2.7 GHz. Modulations modified
• Increased ESD test levels up to 15 kV air, 8 kV contact discharge
• The ESD test method on connectors is modified
• New test: “Close Field Proximity” – Radiated Immunity at 15 discrete frequencies, up to 28 V/m, modified modulations
• New Surge test for devices connected to 12V vehicle power
• Conducted Immunity levels are increased in some cases
• Voltage Dips & Interrupts testing adds additional phase angles
• AC input voltage requirements for all tests are clarified
• The Potential Equalization Conductor must be connected during testing
• If a device is damaged during immunity testing a new procedure has been added
• Magnetic Immunity test levels increased to 30 A/m
• Modified labeling requirements
• Etc….

This new edition of the standard may have a significant impact on the design, testing and documentation of many medical devices.

When do we have to comply with IEC 60601-1-2 4^th edition?
The required date for compliance can be difficult to determine, as the global requirements are not synchronized. It can be a bit a puzzle to solve to determine the mandatory global compliance dates, as it depends on the specific device type, its production status and region the product is marketed. A brief summary by region is shown below:

USA – For new submittals to the FDA, compliance to the 4^th edition will be mandatory by April 1, 2017. 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 2014. During this transition period the FDA also will accept 3^rd edition of the standard as well up til April 1, 2017.

European Union – The Date of Withdrawal (DOW) which is the required compliance date of EN 60601-1-2:2014, is estimated to December 31, 2018. This date will be finalized upon the information being published in the European Official Journal. The DOW date is the end of the grand fathering period for the previous version of the standard, EN 60601-1-2007.  After that date, all devices including legacy devices sold to the EU must comply with the new standard.

Canada – Health Canada has yet to evaluate the 4th edition, therefore the date for mandatory compliance has not been established.

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 may have an undated reference to IEC 60601-1-2.  In this case, compliance to IEC 60601-1-2 4^th edition would be linked to the compliance date of the particular standard with no grandfathering provisions.  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 and you may still need to meet 3^rd edition, as well.  It really depends on what countries you plan to sell too and your regulatory strategy.

We have three EMC experts (Dan Hoolihan, Darryl Ray, & Dan Modi – click the link to see their bio’s) that have joined our ranks recently to help with the additional requests we are starting to see based on IEC 60601-1-2, 4^th edition having a major impact on the redesign of most medical devices.  We are seeing signs of a new wave of projects starting related to IEC 60601-1-2, 4^th ed. and know that this new 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 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 Testing & Documentation – Perform testing (at customer location), 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 and the new IEC 60601-1-2, 4^th edition

• EMC Lab Design, Construction and Setup – Anechoic chamber, shielded rooms & general lab design, vendor negotiations, project management, test equipment setup, etc.

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