The U.S. Food and Drug Administration (FDA) has released a draft guidance document containing a list of recommendations for medical device companies who want to claim electromagnetic compatibility (EMC) of electrically-powered products for premarket submissions. Typically, the review of EMC information in a submission is based on the risk associated with EMC malfunction or degradation of the device, as well as the use of appropriate FDA-recognized standards.
EMC as defined by FDA includes immunity to electromagnetic disturbance (interference), and being free of excessive electromagnetic disturbances (emissions) that might interfere with other devices.
In premarket submissions, manufacturers of electrically-powered medical devices typically reference IEC 60601-1-2 (read about the new 4th edition here) or the equivalent U.S. version. In addition, there are device-specific consensus standards, or “particular” standards (e.g., IEC 60601-2-X, where X denotes a particular device standard). These particular standards may augment or supersede the requirements in the IEC 60601-1-2 standard. There are also other consensus standards for electrically-powered medical devices that include information on EMC (e.g., ISO 147083 for active implantable devices).
According to FDA’s guidance, a claim of EMC for a device should be accompanied by this information:
- Summary of the testing that was performed to support EMC
- The specifications of the standard that were met
- The device-specific pass/fail criteria used
- The specific functions of the device that were tested (including essential performance) and how these functions were monitored
- The performance of the device during each test
- An identification of and a justification for any of the standard’s allowances that were used
- A description of and justification for any deviations from the specifications of the referenced standard
- The device labeling and evidence of compliance with the reference standard’s labeling specifications
- A detailed description of all changes or modifications that were made to the device in order to pass any of the EMC tests.
FDA will accept written or electronic comments and suggestions on this draft through mid-December. Submit electronic comments to http://www.regulations.gov
FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.
Have questions about this guidance, or any other electro-medical device regulatory issue? Ask Pat, our compliance expert. Pat (and MET) have been skillfully performing medical product testing and certification for decades.
This Compliance Today post is a follow up to last week’s post on IEC 60601-1 Edition 3.1.
- Are there safety benefits to the 3rd edition of IEC 60601-1-2 compared to the 2nd?
The test levels required by both the 2nd and 3rd editions of IEC 60601-1-2 are the same. The main change was in clause 4, where 3rd edition implements a risk management process.
So while the test levels are the same, the objective of the testing and what is being monitored may be different in a 2nd and 3rd edition test report. If it can be shown that the 2nd edition testing covered all aspects of basic safety and essential performance identified in the 3rd edition risk management file, then the 2nd edition report can be used to show compliance with the 3rd edition requirements on that basis.
- What does the term “Essential Performance” mean?
Essential Performance is most easily understood by considering whether its absence or degradation would result in an unacceptable risk.
As an example, a patient hoist has 2 performance functions: Raising the patient and lowering the patient. Through risk analysis it would demonstrate that not being able to lift the patient is an acceptable risk, but not being able to lower the patient is an unacceptable risk. So, only lowering the patient is considered Essential Performance
- For devices approved previously with 60601-1, do we have to test for Rev. 3 in the U.S. for FDA and in other places like Europe?
In the U.S., devices approved prior to the transition dates are grandfathered in and do not require further testing to the updated requirements unless they are changed in a way which requires a follow up submission to the FDA.
In Europe, devices placed on the market after the transition dates must meet the new requirements. Currently the 3rd edition of EN 60601-1-2 applies in the EU. After December 31, 2018, EN 60601-1-2 4th edition will be required.
- Is the EU accepting the 4th edition now?
The EU has not explicitly harmonized the 4th edition yet, however it should be possible to justify the use of the 4th edition to a Notified Body reviewer.
- What if your device is meant to generate and receive signals that violate EMC limits?
Radios contained within the device must meet the applicable radio requirements. Intentional emitters that are not radios are covered by CISPR 11 Group 2.
- Are there any examples available of typical EMC test plans?
Annex G contains detailed guidance and an itemized list of what should be in an EMC test plan.
- Given the FDA’s Guidance on Wireless, and now this 4th edition update for RF Immunity, is it expected that this will address those FDA requirements?
There is currently no plan to replace FDA wireless requirements with the 4th edition proximity RF testing, however this opinion may change over time as the intent and scope of the two requirements are similar.
Searching for an independent test lab for the quick and hassle-free testing and certification of your medical electrical equipment? Look no further! MET Labs is the U.S.’s first Nationally Recognized Testing Laboratory, and is the responsive alternative for EMC and product safety certification. Contact us for a free quotation today.
In an effort to remain current with new medical technologies, product safety standard IEC 60601-1 underwent another revision with the 2012 publication of Amendment 1. More than 100 pages in length, Amendment 1 (Edition 3.1) introduces more than 20 new requirements and 60 modifications to existing requirements for medical devices.
For manufacturers of medical electrical equipment and systems, IEC 60601-1 Edition 3.1 (or IEC 60601-1:2005+AMD1:2012) represents a significant departure from Edition 3.0 of the standard. While the application of risk management principles has been clarified, the amended standard includes new requirements regarding essential performance, mandates usability engineering evaluations, and requires the adoption of a formal development life cycle process for software. The amended standard also includes a number of new or revised technical specifications for electrical and mechanical hazards, as well as new product labeling and documentation requirements.
This Compliance Today blog post provides an overview of the new and modified requirements included in IEC 60601-1 Edition 3.1.
Risk Management (Subclause 4.2)
The description of risk management has been rewritten to clarify how ISO 14971:2007 should be applied. The rewrite clarifies that a full ISO 14971 assessment and post-production monitoring are not required for compliance.
Essential Performance (Subclause 4.3)
Amendment 1 now requires manufacturers to establish specific performance limits, and to evaluate essential performance characteristics under abnormal or fault conditions. In addition to these changes, essential performance is now a test criteria in assessing if a hazard is present after a specific test. Also, manufacturers must declare specific essential performance criteria in the product’s technical description.
Humidity (Subclause 5.7)
Humidity testing requirements from IEC 60601-1 Edition 2.0 have been reinstated.
Documentation (Clause 7)
A number of new documentation requirements for user manuals and instructions for use (IFU) have been added. In addition, electronic versions of all accompanying documentation must apply the usability engineering process as covered in the collateral standard, IEC 60601-1-6, Usability, in determining what information must be presented.
Marking and Labeling (Subclause 7.2.2)
Equipment and accessory labeling must include a unique serial number or lot batch identifier, date of manufacturer or “use-by” date, and manufacturer contact information.
Electrical Hazards (Clause 8)
There are a number of changes related to protections from potential electrical hazards, including defibrillation protection, protective earth and creepage and clearance distances. There are new limits for leakage current testing for functional earth connections. Protective earth testing with a power supply cord is required for devices equipped with appliance inlets. Permanently installed equipment must include a power lockout device if reconnection presents a potential hazard to a user.
Mechanical Hazards (Clause 9)
Testing for mechanical hazards related to instability and mobile equipment has been modified to include functional testing.
Temperature Testing (Clause 11)
For applied parts, temperature limits have been clarified. For overflow, equipment must be designed to ensure that basic safety and essential performance are maintained at all times.
Programmable Electrical Medical Systems (PEMS) (Clause 14)
Amendment 1 incorporates many of the specific requirements of IEC 62304:2006, Medical Device Software Life Cycle Processes, which are applicable to equipment and systems whose operation depends on software or any programmable element (also known as PEMS). In addition, Amendment 1 incorporates validation requirements for equipment connected to a network.
Construction (Clause 15)
For mechanical strength, “basic safety and essential performance” replaces “unacceptable risk.” Requirements for the construction of transformers have reverted to IEC 60601-1 Edition 2.0. Lithium batteries must comply with IEC 60086-4 (primary cells) and IEC 62133 (secondary cells).
The U.S. FDA has set a transition date of August 2016 for compliance with Edition 3.1. For the NRTL program, the U.S. Occupational Safety and Health Administration (OSHA) has adopted ANSI/AAMI ES60601-1: 2005/(R2012) and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012. Both of these national standards are deemed the equivalent of IEC 60601-1 Edition 3.1, but they may also include national deviations that trigger additional requirements for regulatory approval. Thus, there is some uncertainty around transition dates.
In the European Union (EU), EN 60601-1:2006/A1:2013 (the EU’s equivalent of IEC 60601-1 Edition 3.1) has been published in the Official Journal (OJ) as a harmonized standard under the EU’s Medical Device Directive (93/42/EEC). So, as of Dec. 31, 2017, compliance with the provisions of EN 60601-1: 2006 (equivalent to IEC 60601-1 Edition 3.0) will no longer be accepted as evidence of conformity with the essential requirements of the Directive.
Adding another level of complexity, transition dates for equipment and systems subject to the requirements of a collateral and/or particular standard in the IEC 60601 series (designated IEC 60601-1-xx and IEC 60601-2-xx) may differ from those applicable to other types of devices.
For device manufacturers that use the IECEE’s CB Scheme, a further challenge is the requirements presented in the IECEE’s Operational Document OD-2055. Published in 2014, OD-2055 requires manufacturers seeking certification to IEC 60601-1 as amended to also comply with the usability engineering process that is detailed in IEC 62366-1:2015.
MET Labs is a leading agency for 3rd party testing and certification of medical electrical equipment to the latest edition of IEC 60601-1 for all major markets. Contact us for questions about Edition 3.1 or for a free quotation to test your device(s).
In July 2014, the FDA recognized the 4th edition of IEC 60601-1-2 as a standard that can be used to show EMC compliance for medical electrical devices and systems.
The complete standard is recognized with the following exception:
In Subclause 8.9, Table 8 on Page 39: The citation of Note b) under “Conducted disturbances induced by RF fields” (4th Row) is not recognized.
Starting on April 1, 2017 the FDA will no longer accept declarations of conformity in support of either IEC 60601-1-2 Edition 3:2007 or ANSI/AAMI/IEC 60601-1-2:2007. This recognition affects all electrical medical devices, except for active implanted devices.
However, a new FDA publication “Design Considerations for Devices Intended for Home Use – Guidance for Industry and Food and Drug Administration Staff” suggests using the 4th edition of IEC 60601-1-2 for Home Healthcare environments now (not 2017!) to cover test levels which may not be properly addressed in the 3rd edition.
Some of the changes to the 4th edition from the 3rd edition of IEC 60601-1-2 are:
- With regards to electromagnetic environments, the “life supporting equipment” category has been removed
- CISPR 15 has been removed as an option for lighting features, replaced by CISPR 11
- ESD test levels were increased for both air and contact type discharges
- RF susceptibility test levels are now specified based on the intended use environment
- Transient tests on DC input power ports in accordance with ISO 7637-2 have been added
- New conducted RF disturbances requirements are based on location of intended use
- Test levels for power frequency magnetic fields increased tenfold, to 30 A/m
- Testing is now at multiple phase angles for the half-cycle, 100% voltage dip
There are many other changes in the 4th edition, contact MET Labs to schedule a new product discovery or existing product ‘gap analysis.’
MET is a leading independent test lab for medical equipment approvals for product safety, EMC and performance. Learn more about Medical Compliance Testing.
IEC 60601-1 3rd Edition for Medical Electrical Equipment Continues to Gain Adoption in Global Markets
The 3rd edition of IEC 60601, issued in 2005, is in various states of adoption by regulatory bodies around the world. IEC 60601-1 is the harmonized standard for medical electrical equipment recognized by public health authorities in most countries. Unlike 2nd edition, the 3rd edition requires a risk management file and process conforming to ISO 14971, the international standard for Application of Risk Management to Medical Devices, in order to show product conformance.
In addition to safety requirements, IEC 60601 includes particular standard requirements for functional safety, software, lasers and EMC.
Following are the known global transition dates.
European Union (EU)
General Standard – June 1, 2012
Particular Standards – Varies, noted by the Official Journal (OJ) of the EU
General Standard with Amendment 1 (EN 60601-1:2006/A1:2013) – June 1, 2018
FDA – From January 1, 2014, FDA requires the 3rd edition of the standard for new product submissions, while for existing products the 2nd edition is still acceptable.
NRTL – In March 2014, OSHA announced through a Federal Register Final Notice its incorporation of ANSI/AAMI ES60601-1 into the list of Appropriate NRTL Program Test Standards. This is the U.S. National Version of IEC 60601-1 + A1.
General Standard – June 1, 2012
Particular Standard – Varies, with a 3-year transition from the date of publication of the particular standard.
Published June 1, 2012, with potential transition in 2017
Classes 3 and 4 + 14 Particular Products – June 1, 2014
Class 2 + 21 Particular Products – June 1, 2015
Class 1 + 19 Particular Products – June 1, 2016
Taiwan & Singapore
Recognize third edition, no transition date announced
MET Labs will continue to provide testing to the 2nd edition of IEC 60601 as long as regulatory bodies continue to recognize it. For those companies launching global products, it may be necessary to maintain a certified 2nd edition test report with local country deviations and also a 3rd edition test report. In those cases, MET offers a dual certification package at a bundled discount.
As a leading medical National Certification Body (NCB), MET can issue a CB Test Report and CB Certificate, for application to CB Scheme participating countries for local marketing approvals.
After a long wait, medical electrical equipment manufacturers are looking forward to the Occupational Safety & Health Administration’s (OSHA) expected near-term recognition of one or more labs – including MET Labs – for product safety certifying medical devices to ANSI/AAMI ES60601-1:2005/(R)2012 under the U.S. Nationally Recognized Testing Laboratory (NRTL) Program.
In March 2014, OSHA announced through a Federal Register Final Notice its incorporation of ANSI/AAMI ES60601-1 into the list of Appropriate NRTL Program Test Standards. This version of the standard is the U.S. National Version of IEC 60601-1 + A1.
OSHA delayed NRTL recognition for the U.S. version of IEC 60601-1:2005 (3rd edition) due to what it saw as subjective compliance requirements, as well as statements in the standard that would have required the NRTL to accept statements from the manufacturer without the ability for the NRTL to verify the validity of these statements.
The changes in language introduced in Amendment 1 (496 changes for the IEC standard) allows the NRTL to verify the validity of data accepted from the manufacturer.
Here are some of the key changes in AAMI ES60601-1 as compared to UL 60601-1:
- Clause 9.6 Acoustic Energy – Not included in UL 60601-1
- Clause 9.7.2-.4 Pressure vessels and parts subject to pneumatic and hydraulic pressure – Not included in UL 60601-1
- Clause 9.7.6 Pressure control device – Not included in UL 60601-1
- Clause 9.8 Mechanical hazards associated with support systems – This is a unique mechanical test not included in UL 60601-1
- Clause 11.2.1 Oxygen Rich Environment – An optional additional test if evaluation is not sufficient for proving that the product is not an ignition hazard in an oxygen-rich environment
- Clause 15.3.5 Rough handling test – Additional ascending shock testing and door frame shock testing is included that was not present in UL 60601-1
- Clause 18.104.22.168 Lithium batteries – Not included in UL 60601-1
MET Labs is OSHA-recognized for UL 60601-1, and is expecting to soon be recognized for ANSI/AAMI ES60601-1:2005/(R)2012 as well. Contact us for a free fast-response quote for electro-medical equipment testing and certification for any major market.
In February 2014, the IEC published IEC 60601-1-2:2014, ed 4.0 for Medical EMC. There are a number of changes in the 4th edition, including new immunity and risk analysis requirements.
For new products in the U.S., the FDA will make a decision on the 4th edition this July, with a likely 3-year transition period (2017 recognition). The FDA does not currently require retesting of legacy products unless changes are made to the product that may affect its compliance.
Canada is planning to review the 4th Edition sometime in 2015 so it will not be accepted before 2015/2016. It’s typically 3 years before accepted standards are required for new submittals.
In Europe, CENELEC has voted affirmatively to accept the 4th edition but has not set a date to withdrawal (DOW) the 3rd edition. The DOW of the current 3rd Edition is expected in the 2017-2018 timeframe. There is no grandfathering in Europe.
Following are some of the key changes in the 4th edition.
Use environments are split into three areas:
- Professional Healthcare Facility Environment
- Home Healthcare Environment
- Special Environment (test levels specified in Annex E)
Small clinic, and Home use equipment need CISPR 11 Class B emission, IEC 61000-3-2 Class A harmonic distortion, and IEC 61000-3-3 voltage fluctuation and flicker. The home use equipment needs 10 V/m, 80 MHz to 1 GHz immunity.
For equipment that is installed in an aircraft or an ambulance, additional testing per ISO 7137 and CISPR 25 applies.
For an EUT with auto ranging power supply, most tests are required to be performed at one nominal voltage only. Only voltage interruptions need to be performed at maximum and minimum voltage if the rated voltage range is >25% of lowest rated input voltage.
Immunity test levels increase:
- The range of testing for radiated immunity harmonized up to 2.7GHz (up from 2.5GHz in the 3rd edition)
- Magnetic immunity at 30A/m
- Conducted immunity at 6V in ISM bands
- ESD at 8kV contact and 15kV air (up from 6kV and 8kV in the 3rd edition)
- Voltage dips and interruptions at additional phase angles
In addition to these Immunity changes:
- Immunity levels (Table 9) are harmonized with IEC 60601-1-11
- Immunity testing now follows the same port-by-port convention of the IEC 61000-6 series of Generic EMC standards
- Immunity to proximity fields from RF wireless communications equipment is now included, and is based on a minimum separation distance of 30cm
- There is a procedure for continuing to test a product that is damaged by an immunity test signal
And Risk Management is expanded:
- Manufacturers will be required to submit a test plan and the risk analysis document before testing
- Operating modes are based on risk analysis
- Reasonably foreseeable electromagnetic disturbances (Annex F) shall be taken into account in the risk management process
- The risk management process is used to determine whether subsystem testing is allowed
- The minimum separation distance are considered in the risk management process
- Reduced test levels (e.g. based on the intended use of the product) must be justified in the risk management file
Contact us for questions about these changes or for a free quote to test and certify medical equipment to any edition of 60601-1.
Due to rapid growth in medical devices that incorporate RF wireless technology, on August 14 the Food and Drug Administration (FDA) released final guidance for integrating radio frequency (RF) wireless technology in medical
devices. The guidance is recommended, but not mandatory.
FDA said its recommendations cover devices that are implanted or worn on the body, and others intended for use in locations such as hospitals and clinical laboratories.
The guidance discusses issues that may affect the safe and effective use of medical devices that incorporate RF wireless technology, including electromagnetic compatibility (EMC).
The use and deployment of RF wireless technology in and around medical devices is an increasing concern because the electromagnetic environments where medical devices are used might contain many sources of RF energy, and the RF wireless emissions from one product or device could potentially affect the function of another, the agency said.
FDA says these issues should be considered for all medical devices that incorporate RF wireless technology, such as Wireless Medical Telemetry Service (WMTS); Medical Device Radiocommunication Service (MedRadio) as well as Medical Micropower Network (MNN) and Medical Body Area Network (MBAN); cellular communication chipsets; and RF identification (RFID) products.
FDA recommends that EMC be an integral part of the development, design, testing, and performance for RF wireless medical devices. Beyond FCC requirements, FDA recommends using risk analysis to identify any potential issues associated with EMC and determining risk acceptability criteria based on information about the device and its intended use, including foreseeable misuse, sources of environmental EMD (e.g., radio transmitters, computer RF wireless equipment), and the potential for RF emissions to affect other devices.
IEC 60601-1-2 is a FDA-recognized consensus standard for EMC, but it does not adequately address whether the wireless communications will operate properly in the presence of in-band EMD (e.g., other RF emissions overlapping the frequency band utilized by the medical device wireless signals). Therefore, the medical device’s wireless communication(s) should be actively transmitting while testing for susceptibility during all EMC immunity testing.
EMC considerations for active implantable medical devices are covered under documents such as the ISO 14708-1 standard (see Appendix B).
FDA worked closely with the Federal Communications Commission (FCC) to develop this guidance.
MET Labs teamed with FDA on a voluntary Program to Test Medical Devices for RFID Interference. Find out more about the Program.
MET’s Annual Global Compliance Seminar in September will include a session on Electrical Medical Equipment Approvals for EU. Register here.
This week, MET’s Product Safety Lab Director Rick Cooper is attending a meeting of a newly-convened standards committee in Long Beach, CA to discuss the creation of a new medical equipment safety of interoperability standard(s) tentatively known as AAMI/UL 2800. The meeting is well attended by interested parties consisting of certification agencies like MET Labs, and manufacturers, consultants, researchers, and medical professionals.
The topic is a very complex one, but essentially a need has been determined that medical equipment shall be designed, tested and certified to be interoperable while maintaining a specified level of safety.
The problem of interoperability is significant. There are so many different makes and models of so many different types of products to consider – e.g. pulse oximeters, blood pressure monitors, EKGs, and on and on. Each has its own unique needs and features. For example, with EKG filter settings, how do you assure this is communicated to connected equipment? What protocol is to be used? This is just one example of many possible scenarios.
This initial meeting will move into a standards development process jointly managed by AAMI and UL via UL’s Collaborative Standards Development System (CSDS).
No firm deadline exists for when this process might result in a standard or set of standards, but everyone in attendance agrees it needs to be as soon as possible. Any resulting standard will be voluntary and not mandatory.
Official minutes of the meeting are due to be released to participants in early July.
For more information, contact Rick Cooper at email@example.com with “AAMI/UL 2800” in the subject line.
Register for a free Overview of 60601-1 3rd Edition Webinar for safety certification of electro-medical devices.
For Medical Electrical Equipment product safety compliance in Canada, Health Canada currently recognizes both the second edition of IEC 60601-1, published in 1988, and the third edition, published in 2005. In October, 2008, Health Canada published a notice indicating that until June 1, 2012, conformity to the second edition of IEC 60601-1 and its related collateral and particular standards would be accepted. After June 1, 2012, conformity to the third edition would be required.
New editions of particular standards (specific to a particular device type and designated as IEC 60601-2-X) harmonized with the third edition of IEC 60601-1 have, in many cases, not yet been published, or have been published only recently, making a full transition to the entire family by the June 1, 2012 deadline impossible.
To address this, on March 22, Health Canada issued Additional Guidance on Transition from the Second to the Third Editions of the IEC 60601 Family of Standards on Health Canada’s List of Recognized Standards. It states:
- If there is not a particular standard that is directly applicable to the device as of June 1, 2012, it should conform to IEC 60601-1 3rd edition and its applicable collateral standards (that is, IEC 60601-1-X).
- If there is a particular standard that is directly applicable to the device and the version that harmonizes with IEC 60601-1 3rd edition was published by IEC before June 1, 2009, then the device should conform to IEC 60601-1 3rd edition and its applicable collateral standards in addition to this particular standard.
- If there is a particular standard that is directly applicable to the device and the version that harmonizes with IEC 60601-1 3rd edition was published by IEC after June 1, 2009, a three year transition period from the date of publication by IEC will apply. During this transition, Health Canada will accept conformity to both editions and related collateral standards.
These transition rules will not be applied retroactively. If the manufacturer currently holds a license for a device that was tested according to IEC 60601-1 2nd edition, you do not need to submit additional data, unless there is a significant change to the product as defined in the Guidance for the Interpretation of Significant Change of a Medical Device.
Keep in mind that provincial or territorial electrical safety requirements are separate and distinct from the requirements of the Health Canada regulations. For further information regarding these requirements, contact the applicable regulatory authorities. A listing of some of these authorities is available here.
The Health Canada website should be consulted for the most current List of Recognized Standards.
For the 3rd edition implementation schedule for the United States, see this Compliance Today post.
Later this month, MET is hosting a free Medical Equipment Regulatory Compliance Seminar in Texas. It features presentations on 60601-1 for product safety and EMC compliance, as well as CE marking.