elements

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

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