БДС EN 60601-1-9:2008

Електромедицински апарати. Част 1-9: Общи изисквания за основна безопасност и съществени характеристики. Допълващ стандарт: Изисквания за проектиране с намаляване въздействието върху околната среда

Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design

Обект и област на приложение

The objective of this collateral standard is to improve the environmental impact for the entire range of medical electrical equipment, taking into account all stages of the product life cycle: - product specification; - design; - manufacturing; - sales, logistics, installation; - use; - end of life management. This means protecting the environment and human health from hazardous substances, conserving raw materials and energy, minimizing the generation of waste, as well as minimizing the adverse environmental impacts associated with waste. The criteria needed to reach this goal must be integrated into all stages of the medical electrical equipment life cycle from the specification stage to end of life management. The environmental impacts of me equipment through all life-cycle stages are determined from the medical electrical equipment's environmental aspects defined during the identification of need, product planning, and design stages. Consideration of environmental aspects as early as possible in these stages can produce numerous benefits that might include lower costs, stimulation of innovation and creativity, and increased knowledge about the product. It can also provide new business opportunities, and improved product quality as well as reduction of adverse environmental impacts. The assessment of the environmental aspects and impacts of medical electrical equipment is a developing science and it is anticipated that this collateral standard will require periodic updating as the science develops. The requirements given in this collateral standard do not replace national or international laws and regulations. Environmental protection is one element of the overall risk management process as required by the general standard. The acceptability of medical electrical equipment's environmental impacts are balanced against other factors, such as the product's intended function, performance, safety, cost, marketability, quality, legal and regulatory requirements. This balance can differ depending on the intended function of the medical electrical equipment. For example, a solution appropriate for life-saving or life-supporting medical electrical equipment might not be appropriate for a device intended to correct a minor ailment. A manufacturer of medical electrical equipment might have to justify, as a result of risk management, that a medical benefit outweighs the associated adverse environmental impacts.