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Step 2: TESTING

Verify production equivalent samples have been received and are operational
Take photographs of device/system and components for report
Conduct testing to the applicable base standard (IEC 60601-1 or IEC 61010-1)
Conduct testing applicable Collateral Standards (if applicable)
Conduct testing applicable Particular Standards (if applicable)
Conduct testing applicable to National Differences

Step 3: DOCUMENTATION REVIEW

Review Risk Management process documentation, based on client-completed form
Review Risk Management file (device-specific) documentation, based on client-completed form
Review user manual and device markings for requirements
Review software documentation (if applicable), based on client-completed form
Review usability documentation (if applicable), based on client-completed form

Step 4: REPORT WRITING (typically in the form of the Internationally recognized Test Report Form, TRF)

Complete clause verdicts and remarks
Complete risk management tables (from completed review)
Complete test data tables (from completed testing results)
Complete critical components table (any component that could affect test results or construction requirements)
Complete applicable National Deviations
Complete Collateral Standards report(s)(if applicable)
Complete Particular Standards report(s)(if applicable)
Attach insulation diagram, markings, photos, manual, applicable drawings, and applicable schematics
Review report
Address review comments
MECA sends client final report/certificate

Step 5 (OPTIONAL): 3rd PARTY CERTIFICATION AND CB REPORTS

Open agency project (UL, TUV Rheinland, or Intertek)
Client executes Agency agreements (required for new clients)
Submit final report to Agency for review and processing
For NRTL Mark, Agency sends client authorization to apply their safety mark
For CB Report, MECA sends client CB Report and UL sends client CB Certificate

Step 1: PRELIMINARY EVALUATION (may be conducted as separate Project)

Review intended use, accessories, interconnections, and classifications
Review and determine applicable standards and project scope (IEC 60601 or IEC 61010 standards)
Perform construction evaluation, per standard(s) requirements
Generate electrical Insulation diagram
Review Critical Components for requirements
Create applicable tests list
Review requirements for user manual and device markings
Review requirements for risk management, software, and usability