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Every Checklist comes with four hours of free consultation. SEPT will answer any question concerning the standard or Checklist for 60 days after purchase.

New! Order the "Self-Extracting File Format" option to get this product in an editable Microsoft Word document!

This checklist was written to conform to edition 3.0 from 2005, not the consolidated 2012 version 3.1

Clause 14 Electrical Medical Systems (PEMS).
This standard contains requirements concerning basic safety and essential performance that are generally applicable to medical electrical equipment. For certain types of medical electrical equipment, these requirements are either supplemented or modified by the special requirements of a collateral or particular standard. Where particular standards exist, this standard should not be used alone. Clause 14 is the software section of this standard. However, what constitutes physical evidence to meet the requirements outlined in Clause 14 is sometimes difficult to identify. To bridge this gap the author and SEPT experts have identified items of physical evidence called out in the standard based on their knowledge of the document and their experience in the quality field. Each item of physical evidence that was identified by these experts is listed in the checklist as; policy, procedure, plan, records, document or reviews.

This checklist is constructed around a classification scheme of physical evidence comprised of policies, procedures, plans, records, documents, and reviews. There are over 100 required or suggested items of physical evidence. In this checklist "manuals, reports, scripts and specifications" are included in the document category.