Evidence Product Checklist For Standard IEC 60601-1 Ed. 3.0 b:2005 “Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance, Clause 14 Programmable Electrical Medical Systems (PEMS)”

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 th e checklist as; policy, procedure, plan, records, document or reviews.