Did You Remember to Review the Electro-Medical Safety Standards that Apply to Your Products?
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), EN 60601-1 (European), AAMI ES 60601-1 or UL 60601-1 (USA – previously called UL2601-1), and CSA C22.2 No. 60601-1 or 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, instructions for use, service or technical manual, the packaging of the device, legibility testing and durability of marking testing . Also a concern are colors for identification of lights/LED’s and push-buttons.
For In-vitro Diagnostic Equipment or lab equipment there are similar standards that apply including IEC 61010-1, EN 61010-1, UL61010-1, and CSA C22.2. No. 61010-1
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 at EisnerSafety dot com