IEC 60601-2-75 Ed. 1.1:2023 (b)
医用電気機器－第2-75部：光線力学治療及び光線力学診断機器の基礎安全及び基本性能の特定要求事項
Medical electrical equipment - Part 2-75: Particular requirements for the basic safety and essential performance of photodynamic therapy and photodynamic diagnosis equipment
発行年月日：
2023-01-30
状態：
有効
邦訳版：
無
英語 131ページ
57,750 円（税込） 本体価格：52,500円
| 規格概要 | IEC 60601-2-75:2017+AMD1:2023 applies to the basic safety and essential performance of photodynamic therapy and photodynamic diagnosis equipment. Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in 7.2.13 and 8.4.1 of the general standard. This document applies to photodynamic therapy and photodynamic diagnosis equipment used for compensation or alleviation of disease, injury or disability. In the case of combined equipment (e.g. equipment additionally provided with a function or an applied part for the target area), such equipment also comply with any particular standard specifying safety requirements for the additional function. This particular standard does not apply to: - light therapy equipment intended for use in photothermal ablation, coagulation, and hyperthermia; - low-level laser therapy equipment not intended for use with a photosensitizer; - illumination equipment intended for use in observation, monitoring, and diagnosis, not intended for use with a photosensitizer. This document is to be used with IEC 60601-1:2005 and its amendment 1. |
|---|---|
| TC |
TC 62/SC 62D |
| ICS |
11.040.01 |
| 備考 |
