TS EN 60601-1-9 Electrical Medical Equipment - Part 1-9: General Features for Basic Safety and Required Performance - Auxiliary Standard: Features for Environmentally Conscious Design

The EN 60601-1-9 standard, developed by the International Electrotechnical Commission (IEC), an affiliate of the International Standards Organization (ISO), describes the conscious design, safety and performance characteristics and test methods of electrical medical equipment in all conditions. This standard has also been published in our country by the Turkish Standards Institute (TSE) with the following title: TS EN 60601-1-9 Electrical medical equipment - Part 1-9: General features for basic safety and required performance - Auxiliary standard: Features for environmentally conscious design .

The aim of this assurance standard is to improve the environmental impact of various types of electrical medical equipment by considering all stages of the product life cycle. In doing so, the equipment 's product characteristics, design, manufacturing, sales, logistics, installation, use, and disposal processes are considered separately. This aims to conserve raw materials and energy, protect the environment and human health from hazardous substances, minimize waste generation, and eliminate negative environmental impacts related to waste.

The criteria set to achieve this goal must be integrated into all phases of the electrical medical equipment life cycle, from design to end of life. The environmental impacts of the medical equipment throughout its life are determined in terms of the needs of this equipment, the environmental conditions during the product planning and design stages. Considering environmental impacts as early as possible provides many benefits, such as lower cost, stimulation of innovation and creativity.

Evaluating the environmental aspects and effects of electrical medical equipment is an emerging science, and the EN 60601-1-9 standard is updated periodically as the science develops. Environmental protection is an element of the overall risk management process as required by this standard.

Conscious design, safety and performance testing services of EN 60601-1-9 electrical medical equipment are also provided to enterprises within the scope of laboratory services by our organization.