Information

Information2019-06-12T19:37:43+00:00

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 ISO 80601 Medical Standards List (Rev 2018-11-17c)

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

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.

Risk Management Guidance Form for ISO 14971

ISO 14971 MECA F 027b – ISO 14971 Client Completion Form (0.2Revision)

  • Covers Clause 4.2.2 of IEC 60601-1, Ed. 3.1, which is ISO 14971, Clauses 3.1 – 8
  • Clients who have an evaluation project with MECA receive this in an editable Word format to complete

Risk Management Guidance Form for IEC 60601-1

IEC 60601-1 MECA F 028c – IEC 60601-1 2012 Risk Management Client Completion Form (0.2Revision)

  • Covers Risk Management referenced Clauses in IEC 60601-1, Ed. 3.1
  • Clients who have an evaluation project with MECA receive this in an editable Word format to complete

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

Medical Alarm Standards Cross-Reference

meca-alarm-standards-cross-reference20150401.pdf (2015-04-01)

  • A comparative resource for those who work with alarm systems and the corresponding standards in the field of medical electrical equipment.
  • Note, IEC authorization has been received to publish wording from these standards.

Medical Standards Project Scope Tool

MECA 60601-80601 Medical Standards Project Scope Tool (Rev 2015-08-17).pdf (2015-08-17)

  • A list of IEC 60601 and the IEC/ISO 80601 Collateral and Particular standards, with their referenced and required additional standards and requirements.
  • This is a great tool to be sure you’ve included everything when determining the applicable standards and requirements.

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.

MECA 60601-1 Ed. 2 with National Differences Evaluation Package

MECA-60601Eval-Rev35.pdf

  • The Evaluation package is a summary of the IEC 60601-1:1988 + A1:1991 + A2:1995 standard, project process, national differences, and guidance information 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.

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