To sign up for this Zoom conversation click here. This Zoom Conversation is being hosted by Rob Packard of Medical Device Academy.

Learn about some of the major changes from the IEC 60601 Amendments coming during this Zoom conversation. Read the below infographic to get an understanding of which standards are being updated, when the updates are estimated, how long the proposed transition period is, what are some of the concerns to consider, and what ways can we help you prepare and train your staff up for these changes.

A reminder that FDA Guidances and Recognized Consensus Standards are voluntary.  But I remind my clients’ that if you don’t use these voluntary documents for premarket submissions you make your life and the reviewer’s life a lot harder, typically.  So, I recommend, in most cases, to use these voluntary documents to speed up the process, in the long run.  In the short run, you may need to do more testing but if you don’t you risk the chance of your product not being accepted by the FDA.

The Guidance goes on to say that “the review of EMC information in a submission is based on the risk associated with EMC malfunction or degradation of the device under review, as well as the use of appropriate FDA-recognized standards or appropriate consensus standards.”  The Guidance indicates that manufacturers typically reference in premarket submissions Recognized consesnsus national (US) and international standards such as IEC 60601-1-2²) (3rd or 4th edition) Medical Electrical Equipment EMC standard, device specific Particular Standards such as IEC 60601-2-XX, and lastly they reference other consensus standards for electrically-powered deevices that include information on EMC such as ISO 14708³ for active implantable medical devices.

The Guidance continues with a listing of details that FDA is expecting manufacturer’s provide in their premarket submissions, so the medical device EMC information is clear and consistent information for the submission, and are consistent with the specifications included in the standards, as referenced above, that are applied to the premarket submission.  The Guidance points to the FDA Recognized Consensus Standards database located at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm.

The rest of the Guidance, Section II “EMC Information”, details the list of items the FDA is expecting of the manufacturer’s for premarket submissions.  And of course the FDA leaves an opening for a broad statement at the end of the section that says: “Additional information not outlined above may be requested by FDA depending on intended use and intended use environment for specific active medical devices (e.g. implantable portions of active devices) to demonstrate the device’s claims regarding electromagnetic compatibility (EMC).”

If you need help with this FDA Draft Guidance or with IEC 60601-1-2 edition 3 or edition 4 or you are interested in our new Eisner Safety Consultants Standards Reconnaissance Database please email Leo Eisner directly at Leo@EisnerSafety.com, or call Leo at +1 (503)-244-6151. He is the Principal Consultant of Eisner Safety Consultants (bit.ly/EisnerSafetyConsultants).

^{Footnotes cited from FDA Draft Guidance Document issued on 2 Nov 2015 titled: “Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices”}

<sup>1. According to International definitions, “disturbance” is the cause and “interference” is the effect. In the US, “interference” is often used interchangeably for both cause and effect though more often for the cause. 
2. IEC 60601-1-2: 2007 [3rd Ed.]:Medical Electrical Equipment – Part 1-2: General Requirements for Safety – Collateral Standard: Electromagnetic Compatibility – Requirements and Tests, IEC 60601-1-2:2014 [4th Ed.], Medical Electrical Equipment, Part 1 2: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Electromagnetic Disturbances – Requirements and Tests, AAMI/ANSI/IEC 60601-1-2: 2007 [3rd Ed.]:Medical Electrical Equipment – Part 1-2: General Requirements for Safety – Collateral Standard: Electromagnetic Compatibility – Requirements and Tests, and AAMI/ANSI/IEC 60601-1-2: 2014 [4th Ed.]:Medical Electrical Equipment – Part 1-2: General Requirements for Safety – Collateral Standard: Electromagnetic Disturbances – Requirements and Tests 
3. ISO 14708-3 Implants for surgery — Active implantable medical devices — Part 3: Implantable neurostimulators</sup>

It would be great to meet you at this workshop or the entire conference and learn something new at the same time.  (See end of post for discount info)

Allison Komiyama, a former FDA reviewer, will be sharing an actual 510(k) that was redacted with us. This will give us a great perspective from the reviewer viewpoint and show us what types of comments and requests for additional information are made.

Robert Packard, a regulatory and quality systems consultant, with lots of 510(k) experience, will be sharing some of his insights into putting a 510(k) together and will focus on several of the more important sections of the 510(k).  He is currently asking for feedback which areas to focus on and you can send him an rob@13485cert.com with your suggestions too.  His current plan is to discuss:

1. provide an overview of the submission requirements with some focus on 510(k) format and contents (Section 2), 
2. review of Indications for Use (Section 4), 
3. review of 510(k) Summary (Section 5), 
4. review of Device Description (Section 11), 
5. review of Substantial Equivalence (Section 12), 
6. review of Performance Testing (Sections 18-20)

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.

From the EMC experts I work with I have heard that some of the test levels have changed significantly and so that will could impact your designs for future compliance testing.  So, a question that is currently unanswered is when will this standard be transitioned into national standards for different countries around the world.  The standard text suggests at least a three year transition period.  It will be up to the different national standards development organizations (SDO’s) and the regulatory bodies around the world to make those determinations.  We will be keeping close tabs on this and reporting any information we hear more.

The foreword of the standard mentions a list of most significant changes from the third edition to the current fourth edition of the standard which include:

– specification of IMMUNITY TEST LEVELS according to the environments of INTENDED USE, categorized according to locations that are harmonized with IEC 60601-1-11: the professional healthcare facility environment, the HOME HEALTHCARE ENVIRONMENT and SPECIAL ENVIRONMENTS;

– specification of tests and test levels to improve the safety of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS when PORTABLE RF communications equipment is used closer to the MEDICAL ELECTRICAL EQUIPMENT than was recommended based on the IMMUNITY TEST LEVELS that were specified in the third edition;

– specification of IMMUNITY tests and IMMUNITY TEST LEVELS according to the PORTS of the MEDICAL ELECTRICAL EQUIPMENT or MEDICAL ELECTRICAL SYSTEM;

– specification of IMMUNITY TEST LEVELS based on the reasonably foreseeable maximum level of ELECTROMAGNETIC DISTURBANCES in the environments of INTENDED USE, resulting in some IMMUNITY TEST LEVELS that are higher than in the previous edition; and

– better harmonization with the RISK concepts of BASIC SAFETY and ESSENTIAL PERFORMANCE, including deletion of the defined term “life-supporting”;

and the following additions:

– guidance for determination of IMMUNITY TEST LEVELS for SPECIAL ENVIRONMENTS;

– guidance for adjustment of IMMUNITY TEST LEVELS when special considerations of mitigations or INTENDED USE are applicable;

– guidance on RISK MANAGEMENT for BASIC SAFETY and ESSENTIAL PERFORMANCE with regard to ELECTROMAGNETIC DISTURBANCES; and

– guidance on identification of IMMUNITY pass/fail criteria.

We will send out a more detailed post on this topic in the future.  Keep an eye out for an update post on this standard.