IEC 60601-1-9 Ed. 1.2 b PDF

IEC 60601-1-9 Ed. 1.2 b – Medical electrical equipment – Part 1-9: General requirements forbasic safety and essential performance – Collateral Standard:Requirements for environmentally conscious design CONSOLIDATED EDITION

IEC 60601-1-9:2007+A1:2013+A2:2020 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 minimizingthe 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 aspectsdefined during the identification of need, product planning, and design stages. Consideration of environmental aspects as early aspossible in these stages can produce numerous benefits that mightinclude 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 asreduction of adverse environmental impacts. The assessment of theenvironmental aspects and impacts of medical electrical equipment is a developing science and it is anticipated that this collateralstandard will require periodic updating as the science develops. The requirements given in this collateral standard do not replacenational or international laws and regulations. Environmentalprotection is one element of the overall risk management process asrequired by the general standard. The acceptability of medical electrical equipment’s environmental impacts are balanced againstother 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, asolution 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 electricalequipment might have to justify, as a result of risk management, that a medical benefit outweighs the associated adverseenvironmental impacts.This consolidated version consists of the first edition (2007)and its amendments, amendment 1 (2013) and amendment 2 (2020). Therefore, no need to order amendment in addition to this publication.