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IEC 60601-1-4 CHECKLIST*

2012 Edition, January 10, 2012

Complete Document

* IN EDITABLE MICROSOFT WORD - Software Engineering Process Technology - Evidence Product Checklist for IEC Standard 60601-1-4, Edition 1.1 2000-04: “IEC 60601-1-4: Medical Part 1: General Requirements for Safety. Part 4 - Programmable Electrical Medical Systems"

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Product Details:

  • Revision: 2012 Edition, January 10, 2012
  • Published Date: January 10, 2012
  • Status: Active, Most Current
  • Document Language: English
  • Published By: Software Engineering Process Technology (SEPT)
  • Page Count: 1
  • ANSI Approved: No
  • DoD Adopted: No

Description / Abstract:

The process of defining what is necessary for compliance with a software engineering process standard such as IEC 60601-1-4 "Medical Electrical Equipment Part 1: General Requirements for Safety. Part 4. Programmable Electrical Medical Systems" is sometimes confusing and laborious because the directions contained in the standard may be unclear or ambiguous. To aid in determining what is actually "required" by the standard in the way of physical evidence of compliance, the experts at SEPT have produced this checklist. This checklist is constructed around a classification scheme of physical evidence comprised of procedures, plans, records, documents, audits, and reviews. SEPT has carefully reviewed IEC 60601-1-4 and defined the physical evidence required based upon this classification scheme. SEPT has conducted a second review of the complete list to ensure that the standard's producers did not leave out a physical piece of evidence that a "reasonable person" would expect to find. It could certainly be argued that if the document did not call it out then it is not required; however if the standard were used by an enterprise to improve its software process, then it would make sense to recognize missing documents. Therefore, there are documents specified in this checklist that are implied by the standard, though not specifically called out in the standard, and they are designated by an asterisk (*) throughout this checklist. If a document is called out more than one time, only the first reference is stipulated.