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PRELIMINARY EVALUATION

  • Review intended use, accessories, interconnections, classifications
  • Review and determine applicable standards and project scope (IEC 60601 Family standards)
  • Construction evaluation, per standard(s) requirements
  • Generating of Electrical Isolation diagram
  • Reviewing of Critical Components for requirements
  • Creating applicable tests list (Test Plan)
  • Reviewing of User Manual and device markings requirements
  • Reviewing of requirements for risk management, software and usability
  • Addressing any initial non-compliances

DOCUMENTATION REVIEW

  • Review Risk Management process documentation (ISO 14971)
  • Review Risk Management file (device-specific) documentation
  • Review User Manual and device markings for requirements
  • Review Software documentation, if applicable (IEC 62304)
  • Review Usability documentation, if applicable (IEC 62366)
  • Addressing any documentation and markings noncompliances

REPORT WRITING

  • Writing Compliance Report (in the international IECEE CB Scheme TRF format)
  • Completing critical components table (any component that could affect test results or compliance with the standard
  • ddrequirements)
  • Completing applicable National Deviations
  • Completing Collateral Standards report(s), as applicable (IEC 60601-1-...)
  • Completing Particular Standards report(s), as applicable (IEC 60601-2-...)
  • Attaching insulation diagram, markings, photos, manual, applicable drawings and applicable schematics, as needed
  • Report Review (internal and by client)
  • Addressing any review comments

(OPTIONAL) US, CANADA NRTL SAFETY MARK AND CB Scheme Certification

TESTING (after any initial noncompliances addressed)

  • Verify production equivalent samples received and operational
  • Testing base standard (IEC 60601-1 for Medical electrical equipment)
  • Production Line Testing (PLT)
  • Check-up service (testing before clinical trials)
  • Testing applicable Collateral Standards (IEC 60601-1-...)
  • Testing applicable Particular Standards (IEC 60601-2-...)
  • Testing National Differences
  • Addressing any testing non-compliances
  • Conduct retesting, as needed
  • Opening project in Agency (TUV Rheinland, CSA, Intertek, UL)
  • Client executes Agency agreements (required for new clients)
  • Follow-up services
  • Submission of final report to Agency for review and processing
  • For NRTL Mark - Agency sends client authorization to apply their safety mark
  • For CB Scheme - ITL issues and sends client CB Certificate and Reports
  • Re-issue reports (by foreign Lab, no mention of Israel in repo rt)
 
 

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