Product Detail:
New and updated checklist for the 2000-04 version of IEC 60601-1-4,"Medical Electrical Equipment-Part I: General Requirements for Safety--4,Collateral Standard: Programmable Electrical Medical Systems".
To reflect the change, SEPT has analyzed the new version and added over 100 physical evidence items that enable compliance, (either as required or recommended items). For medical device firms, use of the Checklist will save time and money, and may aid in meeting certain governmental requirements.
Every Checklist comes with four hours of free consultation . SEPT will answer any question concerning the standard or Checklist for 60 days after purchase.
IEC 60601-1-4 Checklist
This checklist was prepared by analyzing each clause of IEC 60601-1-4 that signify a:
- Procedure
- Plan
- Records
- Document
- Review
- Audit
SEPT has carefully reviewed IEC 60601-1-4 and defined the physical evidence required based upon this classification scheme.
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.
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