IEC 60601-1-9:2007 医疗电气设备 - 第1-9部分:基本安全和基本性能的一般要求 - 附带标准:环境意识设计要求

标准编号：IEC 60601-1-9:2007

中文名称：医疗电气设备 - 第1-9部分:基本安全和基本性能的一般要求 - 附带标准:环境意识设计要求

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

发布日期：2007-07-10

标准范围

IEC 60601-1-9:20 07本附属标准的目的是改善整个医疗电气设备系列的环境影响，同时考虑到产品生命周期的所有阶段:-产品规格；-设计；-制造业；-销售、物流、安装；-使用；-寿命终止管理。这意味着保护环境和人类健康免受有害物质的影响，节约原材料和能源，最大限度地减少废物的产生，以及最大限度地减少与废物相关的不利环境影响。达到这一目标所需的标准必须整合到医疗电气设备生命周期的所有阶段，从规范阶段到报废管理。me设备在整个生命周期中对环境的影响-循环阶段是根据在需求识别、产品规划和设计阶段定义的医疗电气设备的环境方面确定的。在这些阶段尽早考虑环境因素可以产生许多好处，包括降低成本、刺激创新和创造力以及增加对产品的了解。它还可以提供新的商业机会，提高产品质量以及减少不利的环境影响。医疗电气设备的环境方面和影响的评估是一门发展中的科学，预计随着科学的发展，该附属标准将需要定期更新。本抵押品标准中给出的要求不能取代国家或国际法律法规。环境保护是通用标准要求的整体风险管理流程的一个要素。医疗电气设备对环境影响的可接受性与其他因素相平衡，如产品的预期功能、性能、安全性、成本、适销性、质量、法律和法规要求。这种平衡可以根据医疗电气设备的预期功能而不同。例如，适用于救生或支持生命的医疗电气设备的解决方案可能不适用于旨在纠正小病的设备。作为风险管理的结果，医疗电气设备制造商可能必须证明医疗效益超过相关的不利环境影响。

IEC 60601-1-9:2007 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.

标准预览图