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

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Medical Equipment Compliance Associates, LLC

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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

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Download Files

 

Medical Standards List with Publish Dates


MECA 3rd Edition Standards List (Rev. 2017-09-01)
(Note, this document was revised on the specified date, so may not be current)

3rd Edition Harmonized Standards and Projects with Publish Dates (Collaterals, Particulars)
Publish dates of the '60601 and '80601 medical standards and projects

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

 

 

Risk Management Guidance Documents for ISO 14971 and IEC 60601-1


ISO 14971
MECA ISO 14971 Risk Management Guidance Document Rev 1 (2016-06-27).pdf
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 IEC 60601-1 Risk Management Guidance Document Rev 1 (2016-06-27).pdf

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.

 

 

 

 

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