Free Download: IEC 60601-1 Compliance Documents

The following information and document downloads are tools to evaluate medical electrical equipment to the applicable standards.

They are provided for free to aid you in your medical equipment design and development, where this information is most useful.

Please contact us if you have any questions or are interested in having us handle your product’s safety certification.

Medical Standards List with Publish Dates

MECA IEC 60601 IEC/ISO 80601 Medical Standards List (Rev 2024-01-30)

  • (Note, this document was revised on the specified date, so it may not be current)
  • Anticipated publish dates for new standards, editions, amendments
  • To find the current status and issue dates of these standards, see the Links Page, Standards
  • To find and download full standards (which are copyrighted), please see the Resources page, Purchasing Standards

National Regulatory Medical Standards List and US NRTL List

MECA National Regulatory Medical Standards List and US NRTL List (Rev 2023-10-24)

  • (Note, this document was revised on the specified date, so it may not be current)
  • Harmonized Standards with Publish Dates

IEC 60601-1, Edition 3.1 Label-Manual Checklist

MECA IEC 60601-1 Ed3.1 Label-Manual Checklist Rev4.pdf (2015-01-28)

  • Checklist for the requirements of the Labelling and Accompanying documents

MECA 60601-1 Ed. 3.1 Evaluation Package (BETA)

MECA 60601-1 Ed3.1 Evaluation Package BETA (2018-11-24).pdf

  • The Evaluation Package is a summary of the IEC 60601-1:2012 standard, other applicable requirements, guidance information, and interpretations, to help evaluate medical electrical equipment to the requirements of the Standard.
  • It is being provided FREE of charge, to help people understand and meet the requirements for medical devices.
  • The Evaluation Package is not intended to replace the standard, so a purchased copy should also be used.
  • NOTE – This document is still under development, and only pages 1-37 are being provided at this time.
  • It will be updated here as it is completed.

IEC 60601-1 Critical Components Guidance Documents

Critical Components Guidance Table (Rev35).doc

  • Critical Component Guide for IEC 60601-1
  • This guidance document will aid you in identifying your device’s critical components and what specifications they may need to meet for documentation in your Compliance Report.
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