IEC 60601-1-9 Ed. 1.2:2020 (b)
医用電気機器－第1-9部：基礎安全及び基本性能に関する一般要求事項－副通則：環境配慮設計の要求事項
Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design
発行年月日：
2020-07-22
状態：
有効
邦訳版：
無
英語 122ページ
72,187 円（税込） 本体価格：65,625円
- 規格概要
-
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:全文を表示する
- 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,
| TC |
TC 62/SC 62A |
|---|---|
| ICS |
13.020.01 |
| 備考 |
