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분야 | ISO/TC 121/SC 3 : Respiratory devices and related equipment used for patient care |
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적용범위 | This part of the 80601 International Standard applies to the basic safety and essential performance of electroencephalographs as defined in 201.3.204, hereafter also referred to as me equipment or me system. This document is applicable to electroencephalographs intended for use in professional healthcare facilities, the emergency medical services environment or the home healthcare environment. This document does not cover requirements for other equipment used in electroencephalography such as: - phono-photic stimulators; - EEG data storage and retrieval; - ME EQUIPMENT particularly intended for monitoring during electroconvulsive therapy. If a clause or subclause is specifically intended to be applicable to me equipment only, or to me systems only, the title or content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to me equipment and to me systems, as follows. The clause or subclause applies to me equipment, as default. For me equipment with the corresponding safety measure or function not completely integrated into the me equipment but instead implemented in an me system, the me equipment manufacturer specifies in the accompanying documents which functionality and safety requirements are provided by the me system to comply with this document. The me system is verified accordingly. 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. NOTE See also 4.2 of the general standard. |
국제분류(ICS)코드 | 11.040.55 : 진단장비 |
페이지수 | 75 |
Edition | 1 |
No. | 표준번호 | 표준명 | 발행일 | 상태 |
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1 | IEC 80601-2-26:2019/AMD1:2024 | Amendment 1 - Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs | 2024-02-14 | 표준 |
2 | IEC 80601-2-26:2019+AMD1:2024 CSV | Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs | 2024-02-14 | 표준 |
3 | IEC 80601-2-26:2019/COR1:2021 | Corrigendum 1 - Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs | 2021-10-04 | 표준 |
4 | IEC 80601-2-26:2019 | Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs | 2019-05-20 | 표준 |
IEC/DIS 80601-2-23 - Medical electrical equipment — Part 2-23: Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment 상세보기
IEC/DIS 80601-2-52 - Medical electrical equipment — Part 2-52: Particular requirements for the basic safety and essential performance of medical beds 상세보기
IEC/DIS 80601-2-89 - Medical electrical equipment — Part 2-89: Particular requirements for the basic safety and essential performance of medical beds for children 상세보기
IEC/FDIS 80601-2-71 - Medical electrical equipment — Part 2-71: Particular requirements for the basic safety and essential performance of functional near-infrared spectroscopy (functional NIRS) equipment 상세보기
IEC 80601-2-49:2018/Amd 1 - Medical electrical equipment — Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment — Amendment 1 상세보기
IEC 60335-2-82:2017/AMD1:2020 - Amendment 1 - Household and similar electrical appliances - Safety - Part 2-82: Particular requirements for amusement machines and personal service machines 상세보기
IEC 60335-2-8:2012/AMD2:2018 - Amendment 2 - Household and similar electrical appliances - Safety - Part 2-8: Particular requirements for shavers, hair clippers and similar appliances 상세보기
IEC 62031:2008/AMD2:2014 - Amendment 2 - LED modules for general lighting - Safety specifications 상세보기
IEC 60335-2-101:2002/AMD2:2014 - Amendment 2 - Household and similar electrical appliances - Safety - Part 2-101: Particular requirements for vaporizers 상세보기
IEC TS 63134:2020 - Active assisted living (AAL) use cases 상세보기
IEC 60034-5:2020 RLV - Rotating electrical machines - Part 5: Degrees of protection provided by the integral design of rotating electrical machines (IP code) - Classification 상세보기
KS B ISO TS 25740-1 - 에스컬레이터 및 무빙워크에 대한 안전요건 — 제1부: 세계공통 필수 안전요건(GESRs) 상세보기
KS B ISO TS 8100-21 - 승객 및 화물 운송용 엘리베이터 —제21부: 세계공통 필수안전요건(GESRs)을 충족하는 세계공통 안전 파라미터(GSPs) 상세보기
KS C IEC TS 62872 - 산업 시설과 스마트 그리드 사이의 산업 공정 측정, 제어 및 자동화 시스템 인터페이스 상세보기