IEC TR 60601-4-2, “Medical electrical equipment – Part 4-2: Guidance and interpretation – Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems,” has just been released. This new technical report addresses the issue of medical device immunity to electromagnetic disturbances that can occur in the environments where such equipment or systems are used.
Why is this a problem? Electronic equipment manufacturers have long been aware that electronic “noise” or disturbances in an environment can negatively impact equipment performance. So the challenge is to determine what kinds of disturbances will (or could be ) present in the environments in which any particular piece of equipment will be used. And then to figure out how to protect the equipment from these disturbances. This report is specifically directed to medical device manufacturers to help them set up a consistent method for evaluating equipment to insure no degradation of performance in environments with electromagnetic disturbances.
You’ll use IEC TR 60601-4-2 in conjunction with IEC 60601-1-2. You can test for both basic safety and immunity at the same time, either concurrently or sequentially. Of course, the IEC 60601-1-2 test is a pass/fail test. The IEC TR 60601-4-2 test requires meeting criteria set up by the manufacturer. Why? The manufacturer will determine what environments the equipment or system will be in when “used as intended.”
So when you get your copy, you’ll notice that there are the usual scope, referenced documents, and definition sections to start the publication. A general recommendations section follows. Then Section 5 covers medical equipment and systems identification, marking and documents so you’ll know what you’ll need to provide for users to support safe usage. Next come sections on documentation of the tests themselves and on immunity recommendations. This last is the section that helps you determine what kinds of emissions can be expected during the operation of your equipment/systems. The final section is on what needs to be included in the test report. An additional 6 Annexes and a 21-item bibliography complete this 62-page document.
If you’re in the medical device industry, you’ll want a copy of this new part for the essential 60601 series. As IEC notes, you’ll use an authorized distributor like Document Center Inc. for your standards purchase. You can search for and order the standards you need at our webstore, www.document-center.com. Here is a direct link to the order page for IEC 60601-4-2 for your convenience. The document is available in both paper format and for single-user pdf download.
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