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! IEC 60601, 4th Edition Standards ` The International Electrotechnical Commission (IEC) established a set of standards, IEC 60601, for the safety and effectiveness of medical electrical equipment. First published in 1977 and regularly updated, IEC60601 has become a global benchmark for manufacturers developing and marketing medical device products in many countries, including the United States. The 3rd edition of IEC 60601 was published in 2005. The 4 th edition of the Standard will require compliance for products sold in both the United States and European Union by December 31, 2018. Medical devices approved in the U.S. prior to the effectivity date of the new standard are grandfathered in and do not require further testing to the new standard. However, if the device is updated and requires resubmission, then it must be tested to meet the new standard. The 4 th edition of the Standard addresses use of equipment outside hospitals or professional healthcare facilities to include home use and special environments with reduced control of Electromagnetic (EM) disturbances, which can result in increased contributors to the EM environment having detrimental effects on medical devices. The 4 th edition clarifies that medical equipment must 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. Devices will require clear pass/fail criteria prior to testing. IEC 60601 may require medical device suppliers, such as component manufacturers, to meet a subset of the standard. Embedded modules, similar to JADAK’s FM5, SC-6 and/or RFID modules, do not need to be certified to this standard, because our medical device manufacturer customers ensure operation by shielding and protecting the device to meet these stringent tests. However, reputable suppliers will provide their customers with compatible immunity test levels for an added level of confidence when integrating components into devices. On the other hand, some components, such as printers and barcode scanners, which are externally located to the device, must in fact meet the standard. Below is a table outlining parameters, measurement standards, and comparison between EN55024 and EN60601, 4 th Edition. For more information on the Standard, visit www.iec.ch. For JADAK product information, contact us at [email protected].
