Skip to content
MECA – Medical Equipment Compliance Associates Logo MECA – Medical Equipment Compliance Associates Logo
  • Home
  • About
    • Accreditation Certificates
    • Our Team
    • Device Experience
    • MECA History
  • Services
    • Accredited Compliance Reports
    • Preliminary Evaluations
    • Limited Testing with a Letter Report
    • ASCA FDA Program
    • CB Reports
    • Report Revisions
    • Compliance Services
      • Activate Compliance Services
    • 3rd Party Certification Partnerships
    • Medical Device and Laboratory Equipment Testing
    • Seminars
    • Electromagnetic Compatibility (EMC)
    • Wireless Global Access
  • Information
    • Free Downloads
  • Resources
  • Contact
  • Get A Quote

IEC 60601-1 Amd 2

IEC 60601-1 Amd 2MECA2021-04-20T15:17:06+00:00

Home | Services | Get A Quote | Resources | Our Team | Contact Us

© 2023 Medical Equipment Compliance Associates, LLC. All Rights Reserved.

Milwaukee Web Design | Sitemap

Thanks for your inquiry!

We will get in touch shortly.

Thank You For Filling Out Our Contact Form;

We will be in touch with you shortly.

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
Go to Top