Manufacturers developing and marketing medical devices have a staggering number of regulations, guidances, and industry standards to master. One such standard is IEC 60601-1-2. The fourth edition of this standard was published in 2014 and the transition date is fast approaching.
To learn more, we asked Lorenzo Cividino, director, Global Applications and Support at SL Power Electronics, a company that designs, makes, and markets power conversion solutions for a number of applications, including the medical industry, to tell us more about the latest edition.
Who does IEC 60601-1-2 apply to? Why do medical device manufacturers need to pay attention?
Lorenzo Cividino: In general, this standard applies to medical devices sold and/or used in many nations throughout the world. Equipment manufacturers are required to comply with this standard in order to be approved to sell the equipment as a medical device.
The IEC60601-1-2 is a collateral standard to the International Medical Safety Standard, IEC60601-1, which has been adopted by many nations through their national norms (EN60601-1 in the EU, UL60601-1 in USA, for example).
The IEC60601-1-2 defines the basic and essential performance for medical equipment in regard to emissions and immunity to electromagnetic disturbances.
What was the reason for the latest edition?
LC: Revisions to safety and EMC standards are made as experience is gained, and the industry adapts to technical changes and improvements in performance and safety. The 4th edition of this EMC standard addresses use of equipment outside the hospital or professional healthcare facilities to include home use and special environments. The environments have reduced control of Electromagnetic (EM) disturbances, and there are increased contributors to the EM environment that can have detrimental effects on medical devices. The changes also align more with the IEC60601-1 safety standard emphasis on risk management.
What is the biggest change in the fourth edition?
LC: The new 4th edition EMC standard better harmonizes with the risk concepts and basic safety. Life-support equipment is no longer referenced; rather, emphasis is made for the Risk Management File (RMF), and the expectation of the medical equipment to provide Basic Safety and Essential Performance without being interfered by or interfering with other equipment in the electromagnetic environments in which they are intended to be used. With more and more electronics in medical equipment and wireless devices expanding in the market place and used in medical devices, ensuring proper function of devices like infusion pumps, ECG’s, defibrillators, pacemakers, electrical surgical equipment and other devices is paramount.
The fourth edition requires clear pass/fail criteria prior to testing. This is linked to the “Essential Performance and Basic Safety” outlined in the Risk Management File. A test plan is required which includes what is to be monitored in the equipment during testing. There are increased test levels for the immunity requirements. There are also new immunity requirements added that take into consideration the effects from RF wireless communications equipment as detailed in Table 9 of the standard. These are not all encompassing, as the medical device manufacturers need to take into account other possible sources of interference that may affect their equipment. The electromagnetic immunity requirements are detailed in Tables 4 through 9 of the standard.
Which increases in immunity test levels are most significant, in your opinion?
LC: The most notable changes to the immunity standard are: the increased electrostatic discharge (ESD) level, increased from 6KV/8KV to 8KV/15KV, contact and air discharge respectively, radiated RFE fields and proximity fields from RF wireless communication equipment. Although there are other immunity requirements that have changed, and increased in level for the most part, the other changes have not been as challenging to mitigate, at least in terms of the AC/DC power supply’s ability to aid in complying with the new requirement.
The transition date for the fourth edition in the United States is April 1, 2017. Are most medical device manufacturers already ready for the transition, or do they still have a lot of testing to perform?
LC: Major medical device manufacturers have compliance engineers or departments which are well informed of the changes in regulatory standards. In addition, major compliance test facilities are also well informed of the requirements for the IEC60601-1-2 4th edition and provide training to clients about the changes and how to plan for them. The medical device development and approval cycle is 2 -3 years. With the required compliance date of April 2017 by the FDA and end of 2018 in the EU, device manufacturers have been preparing for these changes well in advance.
Editor’s note: In 2016, FDA extended its compliance date. That date is now December 31, 2018, the same as the date in the EU.
What about legacy medical devices—how should manufacturers approach testing for those products?
LC: Medical devices approved in the USA prior to the affectivity date of the new standard are grandfathered in and don’t require further testing to the new standard. However, if the device is updated and requires resubmission, then they will be tested to the new standard.
In Europe, medical devices need to comply with the latest standard in effectat the time of manufacture or sale in the market. Currently, the 3rd edition of EN60601-1-2 is in effect, but is expected to be withdrawn and replaced by the 4th edition by the end of December 2018.
Let’s talk about the risk management aspects of the fourth edition. What are the biggest changes manufacturers need to be aware of?
LC: The 4th edition now incorporates the Risk Management requirements into the standard, expanding to include electromagnetic disturbances and providing guidance for the determination of the immunity test levels for special environments and guidance identifying the immunity pass/fail criteria.
How much of this risk management and testing does the manufacturer need to take on and how much can be outsourced or addressed using suppliers?
LC: The medical device manufacturer is responsible for providing evidence of compliance to the standard since ultimately this is an end product specification and needs to be tested at that level. Suppliers play a part in the process in so far as their product contributes to or mitigates the emissions and immunity requirements of the IEC60601-1-2. Suppliers may perform tests from the standard to demonstrate that they should not negatively affect the medicals device’s ability to comply; however, the medical device must be tested.
What else should manufacturers be aware of?
LC: Review the documentation of the tests requirement in section 6. Detailed test plans shall be provided to the test laboratory along with monitoring and pass/fail criteria detailed in section 8.