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USEFUL PROGRAMS AND DOCUMENTS FOR FREE DOWNLOAD

The following documents and program are useful tools to evaluate medical electrical equipment to the IEC/UL/CSA/EN 60601-1 standards.
They are provided for free to aid you in your medical equipment design and development, where the information can help you the most.
Please contact us if you have any questions or are interested in saving time and money on your product's safety certification.

Thank you,

Brian R. Biersach
President, Sr. Biomedical Engineer
262-752-4017 x601
bb@60601-1.com

PLEASE email me if you are not able to download a document, and I will reply with the file.

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.


Convert.zip
153 KB

Convert  - An excellent conversion program that handles all sorts of units, with a small file size.
No installation, just download it, unzip it, and run it.   (You can also download it at http://www.joshmadison.com/software/)
Of the many, many conversion programs I have tried, this is by far the best (Thanks to Josh Madison).


Acrobat

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


MECA-60601Eval-Rev34.pdf
Rev. 34 (2007-03-01)
725 kB

Evaluation Package for IEC/UL/CSA/EN 60601-1 (Rev. 34)
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.
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.

The Package is periodically updated with new information, significant interpretations, and collateral/particular standard that have been published.
 


60601 Label-Manual Checklist (Rev 34).pdf
(2007-03-01)
240 kB

Label and Accompanying Documents (Manual) Requirements Checklist (Rev. 34)
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


60601 Critical Components Checklist (Rev34).doc
(2007-03-01)
215 kB

Critical Component Guide (Rev. 34)
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


60601Data Package2008-11.doc 
(2008-11-25)
1,383 kB

Test Data Package for IEC/UL/CSA/EN 6001-1 (Rev. 37)
Test data package for recording test results from the IEC/UL/CSA/EN 60601-1 standards.
 


60601symbols.doc 
(2007-03-01)
311 kB

Symbol Tables from IEC/UL/CSA/EN 60601-1
Tables DI & DII - Symbols from the '60601 standards.


ULclassification.doc
(2007-03-01)
131 kB

UL Marking and Wording Requirements
Required wording for the UL Mark (Labels and Accompanying Documents).


Information\Service Request
Online Form

To request additional information or a quote for services, please complete the online form.
We do not release any information submitted on this form. It is for quoting and answering questions only.


UL Mark Graphics

High Resolution UL Marks
UL website link to download the high resolution UL Classification Mark, and other UL Marks.
- For medical equipment, use the "UL Classification Mark for Canada and the United States" mark.