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LABELING:
Did Your Company Remember
to Review the Electromedical
Product Safety Standards that Apply?
An important part of labeling that is often missed is the marking and labeling requirements of the electro-medical product safety standards that apply to your products. Luckily, the requirements are almost identical for the major markets of the USA, Canada, and Europe. Electrically powered medical devices use IEC 60601-1 (International standard, previously called IEC 601-1), EN 60601-1 (European), UL 2601-1 (USA), and CSA C22.2 No. 601.1 (Canadian). These standards are all based on IEC 60601-1 with some national deviations. The areas of concern for labeling include use of international symbols, markings and warnings on the product, in the instructions for use, service or technical manual and on the outside packaging of the device. Also a concern are colors for identification of lights/LED's and push-buttons. Another item to note is that marking durability of product markings is evaluated under the standards and is an issue to review closely. For
In-vitro Diagnostic Equipment or lab equipment there are similar standards that
apply including IEC 61010-1, EN 61010-1, UL3101-1, and CSA C22.2. No. 1010.1 To find out
more about labeling requirements, or to get assistance for labeling review of a
product or product line, or the product safety requirements for your products
please contact us at Leo@EisnerSafety.com |
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