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USEFUL PROGRAMS AND DOCUMENTS FOR FREE DOWNLOAD |
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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 x101
bb@60601-1.com
PLEASE
email me if you are not able to download a document, and I will reply
with the file. |
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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. |
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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). |
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Acrobat
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Retrieve your free copy of the Adobe Acrobat Reader for
viewing the following documents. |
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IEC 60601-1, 3rd Edition Documents |
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60601 Ed3 Standards
(2011-11-15).pdf |
3rd Edition Harmonized Standards and Projects with Publish
Dates (Collaterals, Particulars) (Updated
2011-11-15)
NOTE - This is dated information, to be used as a guidance document.
Please log on to the IEC, ISO, and New Approach websites to assure
that you are using current standards and dates.
Publish dates of the '60601 and '80601 medical standards and projects.
Also includes the EU Official Journal transition deadline dates.
- Part of the soon to be added MECA 3rd Edition Evaluation Package. |
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2012-01-06
MECA Risk Management Guidance & Report 1.pdf
Rev. 1 (2012-01-06) 1.53MB |
New 3rd Edition Risk Management Guidance and Report Document (Rev.
1)
This document and guidance is in a new format, based on working with
clients, Certification Agencies, and Notified Bodies.
In addition to the information required for the IEC 60601-1 Test
Report Form Risk Management Tables, this document provides a tool to
get the information required to conduct the testing and complete the
clauses in the report.
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.
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MECA 60601-1
Ed3 Label Manual Checklist.pdf
Rev. 3.1 (2011-11-10) |
3rd Edition Labels and User Manual Checklist
(Rev. 3.1)
Label and User Manual requirements checklist for IEC 60601-1, Ed. 3. |
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Critical Components
Table (Rev35).doc
(2010-04-03)
235 kB |
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 |
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IEC 60601-1, 2nd Edition Documents |
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MECA-60601Eval-Rev35.pdf
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. |
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60601 Label-Manual
Checklist (Rev35).doc
(2010-04-03)
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 |
