The standard for environmentally conscious design, IEC 60601-1-9, was published in 2007 (amended in 2013) as a collateral standard to IEC 60601, the widely accepted series of international standards for the basic safety and essential performance of medical electrical equipment. Compliance with the IEC 60601 series is required by regulatory bodies responsible for electrical medical equipment in many countries.
The requirements of IEC 60601-1-9 are based on practical experience made by reputable medical manufacturers which showed that the application of the standard may result in cost savings and marketing benefits.
Clients continue to increase pressure on manufacturers to develop medical devices with an environmentally conscious design, as it is seen as an aspect of an overall good design practice.
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