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IEC 60601-1
Medical Equipment Compliance,
Certification, and Regulatory Services and Information

Medical Equipment Compliance Associates, LLC

Free Download:
IEC 60601-1 Compliance Documents

 

The following information and document downloads are tools to evaluate medical electrical equipment to the applicable standards.
This includes IEC 60601-1 with the Collateral and Particular standards for medical equipment and ISO 14971 for risk management.
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.

Please email me if you are unable to download a document

Brian R. Biersach

President, Sr. Biomedical Engineer

bb@60601-1.com

Documents are in either Adobe Acrobat or Word format

Click on the Document name or icon to open

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.

The IEC 60601-1:2012 standard can be found on the IEC Webstore: https://webstore.iec.ch/publication/2612

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 Documents for ISO 14971 and IEC 60601-1

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

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, 3rd and 2nd Editions)

This document will aid you in identifying your device's critical components and what specifications they need to meet

The guide gives specifications that will be used to document your critical component list in your Compliance Report

(ARCHIVE) IEC 60601-1 Edition 2 Evaluation Package

MECA-60601Eval-Rev35.pdf

A complete checklist of requirements in IEC 60601-1 with the UL, EN, CSA, and all the other National Deviations
for global requirements, and significant interpretations (harmonized with 2nd Edition of IEC 60601-1).

Also contains a list of the collateral and particular standards, a "cheat sheet" for the testing values and limits, and other tools for medical device evaluation to these standards.