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.
Dear Ms. President Claudia Bach,
Browsing on the website http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm we can find the standard AAMI ANSI EC38:2007 (Rec. Nr. 3-65) in the list of the recognized standards and the standard referred above (ANSI/AAMI/IEC 60601-2-47:2012) is missing from this list.
We would like to apply for FDA registration of our ECG Holter system and actually the performance tests were performed according to the standard EN 60601-2-47:2001 (IEC 60601-2-47:2001). Please inform us which standard we have to use in case of reviewing and extending our tests so as to be able to apply for registration. Do we have the opportunity to refer on the ANSI/AAMI/IEC 60601-2-47:2012 instead of the AAMI ANSI EC38:2007 without risking our application to be rejected?
Thank you in advance for your answer.
Yours sincerely,
Zsolt Katonai
Thanks so much for asking, Zsolt:
This is an example of the problems we run into all the time with the adoption of industry standards for public use. I will be doing some research for you on this question but I appreciate that you bring it to my attention.
When U.S. regulatory agencies use an industry standard, they sometimes forget that the documents change over time. In this case, you are quite correct. The AAMI EC38 has been withdrawn and replaced by the 60601-2-47 national edition.
It stands to reason that it is appropriate to meet the current 60601-2-47 document since the EC38 is obsolete. I’ll check with my contacts at both AAMI and the FDA to see if I can get an “official” response for you.
Great question!
Best regards,
Claudia Bach
Document Center Inc.