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For thr standard IEC 60601-1-4 Medical Electrical Equipment, General Requirements for Safety, Programmable Electrical Medical Systems
Download (PDF) 135 KB, 80 pages
Item No.: RCG007ASEP, published August 2001
Description
New and updated checklist for the 2000-04 version of IEC 60601-1-4 ”Medical Electrical Equipment, part I: General Requirements for Safety, and part 4: Collateral Standard: Programmable Electrical Medical Systems”. This revised version of the chrcklist IEC 60601-1-4 includes over 100 additional physical evidence items that enable compliance with IEC 60601-1-4, (either as required or recommended items). The checklist uses a classification scheme of physical evidence comprised of procedures, plans, records, documents, audits, and reviews. This revision clarifies what is required for compliance by providing an easy-to-use product evidence list that will assist any software organization in meeting the requirements of standard IEC 60601-1-4. For medical device firms, use of the checklist will save time and money, and may aid in meeting certain governmental requirements that are also included in this IEC 60601-1-4 checklist. The purchase of the checklist includes four hours of free consultation during 60 days after date of purchase, concerning questions about the standard IEC 60601-1-4 and the checklist. The checklist is a quality product at a reasonable price!
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