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 IEC 60601-1-9 standard, prepared by the International Electrotechnical Commission (IEC), an affiliate of the International Standards Organization (ISO), is designed to improve the environmental impact for the entire range of medical electrical equipment, taking into account all stages of the product life cycle.

This standard has been published in our country by the Turkish Standards Institute 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 product life cycle refers to the management of the product characteristics, design, production, sales, logistics, installation, usage and end-of-life processes of medical electrical devices and medical electrical systems. In this way, in order to improve the environmental impacts of medical devices and systems, it is aimed to protect the environment and human health from hazardous substances, to protect raw materials and energy, to minimize waste generation and to eliminate bad environmental effects related to waste. The IEC 60601-1-9 standard sets out the criteria required to achieve this goal.

The environmental aspects of medical devices and systems should be determined starting from the planning and design stages. In addition, detecting environmental aspects as early as possible brings numerous benefits to businesses, from lower costs to innovation. The standard will continue to be developed as developments in science and technology continue.

Environmental protection is an element of the overall risk management process as required by the standard. The acceptability of the environmental effects of medical electrical equipment, the intended use of the product, its performance, safety, cost, balanced by other factors such as its marketability, quality and regulatory requirements.

Tests in accordance with IEC 60601-1-9 standard are also carried out by our organization within the scope of medical device tests.