IEC 60601-1-9:20 07+A1:2013该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 危害人类健康，保护原材料和 能源，尽量减少废物的产生，以及尽量减少 与废物相关的不利环境影响。The 实现这一目标所需的标准必须纳入所有 医疗电气设备生命周期的各个阶段 规范阶段至报废管理。环境 me设备在整个生命周期中的影响-确定循环阶段 从医用电气设备的环境方面 在需求识别、产品规划和 设计阶段。尽早考虑环境因素 在这些阶段可能会产生许多好处 包括降低成本、刺激创新和创造力，以及 增加了对产品的了解。它还可以提供新的 业务机会，并提高产品质量以及 减少对环境的不利影响。评估 医疗电气设备的环境方面和影响 一门发展中的科学，预计这种抵押品 随着科学的发展，标准需要定期更新。The 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 保护是整个风险管理过程的一个要素，因为 通用标准要求的。医疗的可接受性 电气设备对环境的影响与 其他因素，如产品的预期功能、性能， 安全性、成本、适销性、质量、法律法规 要求。这种平衡可能因预期而异 医用电气设备的功能。例如，一个 适用于救生或生命支持医疗的解决方案 电气设备可能不适合预期的设备 纠正小病。医疗电器制造商 作为风险管理的结果，设备可能必须证明， 医疗益处大于相关的副作用 环境影响。 本合并版本由第一版（2007年）组成 及其修正案1（2013年）。因此，无须在 本出版物的补充。

IEC 60601-1-9:2007+A1:2013 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. This consolidated version consists of the first edition (2007) and its amendment 1 (2013). Therefore, no need to order amendment in addition to this publication.