AAMI (the Association for the Advancement of Medical Instrumentation) has just released ANSI/AAMI/IEC-60601-2-47, “Medical electrical equipment – Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems,” and it’s available now from Document Center Inc. The new U.S. national version of IEC 60601-2-47 replaces AAMI EC38 and specifies the basic safety and essential performance of ambulatory electrocardiographic (ECG) systems.
Within the scope of this national adoption are systems of the following types:
a) systems that provide continuous recording and continuous analysis of the ECG allowing full re-analysis giving essentially similar results. The systems may first record and store the ECG and analyze it later on a separate unit or record and analyze the ECG simultaneously. The type of storage media used is irrelevant with regard to this standard; and
b) systems that provide continuous analysis and only partial or limited recording not allowing a full re-analysis of the ECG.
The publication of the 64-page ANSI/AAMI/IEC 60601-2-47:2012 is possible because AAMI is the U.S. TAG (Technical Advisory Group) to the committee that writes the IEC 60601-2-47 document. Every country that participates in IEC has the right to publish national translations of IEC (International Electrotechnical Commission) standards. In this case, the U.S. adoption may have spelling differences from the original IEC publication, reflecting the differences in spelling between the original British English and the American usage.
Benefits of using a national adoption range from the possibility of a lower price for the national edition to possible introductory material written with the national user in mind. The downsides are the time lag between the publication of the original standard and the release of the national adoption (due either to publication concerns or administrative overhead) and issues of jurisdiction (will the U.S. adoption be acceptable to your European certifier?).
All current AAMI standards are available in both paper and pdf format from Document Center Inc. at our website, www.document-center.com. Or you may prefer to contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). We’re happy to help you sort your way through the many options you have when purchasing the standards you use in your business.