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IEC 60601-1-4
Checklist
for Medical Electrical
Equipment |
IEC 60601-1-4
Evidence
Product Checklist for
Edition 1.1 2000-04 Medical Electrical
Equipment
Part 1: General Requirements for Safety
Part 4. Programmable Electrical Medical
Systems
by Stan Magee (read
about the author)
E-Book
80 Pages
Published August
2001
Download (PDF) 135 KB
Item No.: RCG11SEPTRCG
List Price: US $ 149.00
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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! |
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