|
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-Rev35.pdf
Rev. 35 (2010-04-03)
576 kB |
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 3rd Edition Evaluation Package is nearing
completion, and will be added as soon as it is complete.
|
|
60601 Label-Manual
Checklist (Rev35).doc
(2010-04-03)
921 kB |
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 |
|
Critical Components
Table (Rev35).doc
(2010-04-03)
235 kB |
Critical Component Guide (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 |
