IEC 60601-1-4 for Medical Electrical Equipment
Checklist

Evidence Product Checklist for the Standard IEC 60601-1-4
Edition 1.1 2000-04 Medical Electrical Equipment
Part 1: General Requirements for Safety
Part 4. Programmable Electrical Medical Systems

by Stan Magee

E-Book 80 Pages
Published  August 2001
Download (PDF) 135 KB
Item No.: RCG11SEPTISO

List Price: US $ 149.00
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 includes over 100 additional physical evidence items that enable compliance, (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 this standard. For medical device firms, use of the checklist will save time and money, and may aid in meeting certain governmental requirements. The purchase of the checklist includes four hours of free consultation during 60 days after date of purchase, concerning questions about the standard and the checklist. The checklist is a quality product at a reasonable price!