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Celebrating 11 Years of Compliance Service (Founded July, 2002)






Documents are in Adobe Acrobat and Word format, and the file size is listed below the link in red.
Click on the Thumbnail or Document filename to open and right click and choose "Save As" to download.

153 KB

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Of the many, many conversion programs I have tried, this is by far the best (Thanks to Josh Madison).


Retrieve your free copy of the Adobe Acrobat Reader for viewing the following documents.

IEC 60601-1, 3rd Edition Documents

IEC 60601-1-XX, -2-XX Standards

IEC/ISO 80601-2-XX Standards

ISO 80601-2-XX Standards

EN 60601 and 80601 Standards Search Link

European OJ (Official Journal) List of Standards and Due Dates
(Scroll just over half way down to the EN 60601-1 standards)

3rd Edition Harmonized Standards and Projects with Publish Dates (Collaterals, Particulars)

Publish dates of the '60601 and '80601 medical standards and projects.

Due to the quickly changing list, we have provided the link to the IEC, ISO, and EN standards lists.
For the European OJ, scroll half way down the linked page, to get to the EN 60601-1 standards.

Once all of the Particular Standards get revised, corrected, and published, we will provide a single list again.

MECA 3rd Edition Risk Management Guidance & Report - IEC 60601-1 Ed. 3.1 - Revision 0.0.pdf

MECA Assessment - ISO 14971 2007 - Rev 0.0.pdf

New IEC 60601-1, Edition 3.1 and ISO 14971:2007 Risk Management  Guidance and Report Documents (2013-03-08)
These two documents are required to be completed, to address the requirements of the IEC 60601-1, Ed. 3.1 standard.

The first contains the risk management required for the IEC 60601-1 standard and report.
The second contains the ISO 14970 requirements, that populate the Clause 4.2.2 table of the IEC 60601-1 form.

In addition to the information required for the Test Report Form (TRF) risk management tables, this document provides guidance for meeting the risk management requirements in the standard.

The file is provided for free in a locked pdf format. 
Clients who have an evaluation project with MECA receive the Word format file, to complete for the project.

MECA 60601-1 Ed3 Label
Manual Checklist.pdf

3rd Edition Labels and User Manual Checklist (Rev. 3.1)
Label and User Manual requirements checklist for IEC 60601-1, Ed. 3.
- Part of the soon to be added MECA 3rd Edition Evaluation Package.

Critical Components Table

Critical Component Guide (for IEC 60601-1, 3rd and 2nd Editions) (Rev. 35)
This MS Word 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 Informative Test Report.
- Included in the Evaluation Package

Link to Document:
3rd Ed EN_60601-1_
11 - V1.1.pdf

Working Document for NBRG - Frequently Asked Questions related to the Implementation of EN 60601-1:2006 with respect to MDD 93/42/EEC

This document was published to clarify the many questions that relate to the implementation of EN 60601-1:2006 within the EU under the scope of MDD 93/42/EEC.

Please note that Question/Answer 3.3.9 may be misleading, since any device that required a fire enclosure under the 2nd Editon (for example, required a flame rated plastic) do need to meet the bottom openings requirements in the 3rd Ed. standard.

IEC 60601-1, 2nd Edition Documents

Rev. 35 (2010-04-03)

2nd Ed. Evaluation Package for IEC/UL/CSA/EN 60601-1 (Rev. 35)
A complete checklist of requirements in IEC 60601-1, UL 60601-1, EN 60601-1, CSA C22.2 No. 601.1, and all the other National Deviations for global requirements, 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.

This will be the last revision of the Evaluation Package for the 2nd Edition Harmonized standards. The next Edition will be for the 3rd Edition of IEC 60601-1.

60601 Label-Manual
Checklist (Rev35).doc
921 kB

2nd Ed. Label and Accompanying Documents (Manual) Requirements Checklist (Rev. 35)
This document is a checklist of the Clause 6 Label and accompanying Document requirements (User Manual, Instructions, etc.) from IEC/UL/CSA/EN 60601-1.
- Included in the Evaluation Package