EMC
Marking & Labeling Workbook
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Are you developing or selling a medical product--
- that has a new pre-market approval for the FDA?
- that is CE marked to the Medical Device Directive (93/42/EEC)?
- that falls under the Canadian Medical Regulations (SOR/98-282)?
If your product falls into any of the above categories, the 2nd
Edition of IEC 60601-1-2:2001, Electromagnetic
Compatibility Requirements and Tests for Medical Electrical Equipment
is required as of November 1, 2004.
Eisner Safety Consultants is offering an EMC Workbook can help speed you along your way in complying with the marking
and labeling changes to the standard.
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Compliance engineers, EMC engineers, design engineers or teams,
regulatory affairs personnel, or anyone who needs to understand the EMC marking
and labeling requirements of IEC 60601-1-2:2001 2nd Edition,
will find the EMC Workbook an indispensable tool in developing EMC
marking and labeling for their:
- product,
- manuals, and
- service manuals
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The Workbook provides the user with:
- a way to quickly classify the product to the standard that is pertinent to the
marking and labeling requirements;
- a definition of what labeling and marking requirements apply to the product
based on the classifications made;
- sample wording for many of the labeling and marking requirements, warnings,
etc., in the standard which requires a minimum of information to complete;
- tables from the standard which are easily completed by filling in basic
information such as test data, model number, etc.;
- Excel spreadsheets to perform calculations based on your test results required
for certain tables.
View sample
pages of the workbook (pdf 668Kbytes). The sample includes the table of contents, and
several sample pages.
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Why spend thousands of dollars on internal and external resources
figuring out these complex
requirements for EMC marking and labeling when you can spend only $295.00
and
cut your time and costs markedly. Your
firm will spend less time and money creating EMC marking and labeling
documentation.
To place an order, either pay by credit card via paypal
or
send a check (from a United States bank) or money order for $295.00 to:
Eisner Safety Consultants
3331 SW Seymour St.
Portland, OR 97239
(503) 244-6151
Contact: Leo Eisner or Diane Doctor
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