IEC 60601-1 Edition 3.1, “Medical electrical equipment – Part 1: General requirements for basic safety and essential performance,” has just had Interpretation Sheet 3 released. The Interpretation Sheet is available from Document Center Inc. in both paper and pdf format.
The IEC 60601-1 is the General Overview document for the IEC 60601 Series. It has been adopted by countries the world over as the benchmark for the import of medical devices. The standard is usually republished as a national or regional edition to account for the variances in country specific requirements.
The IEC Interpretation Sheets are issued when a section of a standard needs to be clarified by the committee. The impetus for the release is usually one or more requests by users of the standard. There is a strict protocol for the submission of queries and the publication of these documents.
In this particular case, IEC 60601-1 Interpretation Sheet 3 discusses Subclause 13.1.2, the 4th dash (Emissions, deformation of enclosure or exceeding maximum temperature). The text of the clause is reprinted and then is discussed at length in 4 paragraphs (a little over 1 page). The exact way that the committee intends for uses to meet the clause is reviewed at length to avoid any further confusion over the language in the subclause.
The Interpretation Sheet is 4 pages in length due to the inclusion of the information both in English and in French.
You will want to have the IEC 60601-1 Interpretation Sheets if you use the standard. They will help you avoid errors due to a misreading of the text.
These sheets are available from Document Center Inc. You can request information via a request for quote at our web store, www.document-center.com. Or you can contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).
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