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IEC 60601-2-75:2017+AMD1:2023 CSV
Medical electrical equipment - Part 2-75: Particular requirements for the basic safety and essential performance of photodynamic therapy and photodynamic diagnosis equipment- 발행일 : 2023-01-30
- 발행기관 : IEC
상세정보
| 분야 | TC 62/SC 62D : Particular medical equipment, software, and systems |
|---|---|
| 적용범위 | IEC 60601-2-75:2017+AMD1:2023 CSV 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. |
| 국제분류(ICS)코드 | 11.040.01 : 일반 의료장비 |
| 페이지수 | 131 |
| Edition | 1.1 |
이력정보
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | IEC 60601-2-75:2017/AMD1:2023상세보기 | Amendment 1 - Medical electrical equipment - Part 2-75: Particular requirements for the basic safety and essential performance of photodynamic therapy and photodynamic diagnosis equipment | 2023-01-30 | 표준 |
| 2 | IEC 60601-2-75:2017+AMD1:2023 CSV상세보기 | Medical electrical equipment - Part 2-75: Particular requirements for the basic safety and essential performance of photodynamic therapy and photodynamic diagnosis equipment | 2023-01-30 | 표준 |
| 3 | IEC 60601-2-75:2017상세보기 | Medical electrical equipment - Part 2-75: Particular requirements for the basic safety and essential performance of photodynamic therapy and photodynamic diagnosis equipment | 2017-05-30 | 표준 |
관련상품
- IEC/DIS 60601-2-26 - Medical electrical equipment — Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs
- IEC 60601-2-15:1988 - Medical electrical equipment. Part 2: Particular requirements for the safety of capacitor discharge X-ray generators
- IEC 60601-2-14:1989 - Medical electrical equipment. Part 2: Particular requirements for the safety of electroconvulsive therapy equipment
- IEC 60601-2-32:1994 - Medical electrical equipment - Part 2: Particular requirements for the safety of associated equipment of X-ray equipment
- IEC 60601-1-4:1996 - Medical electrical equipment - Part 1: General requirements for safety - 4. Collateral standard: Programmable electrical medical systems
다른 사람이 함께 구입한 상품
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