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Medical electrical equipment — Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
| 분야 | ISO/TC 121/SC 3 : Respiratory devices and related equipment used for patient care |
|---|---|
| 적용범위 | ISO 80601-2-61:2011 applies to the basic safety and essential performance of pulse oximeter equipment intended for use on humans, hereafter referred to as ME equipment. This includes any part necessary for normal use, including the pulse oximeter monitor, pulse oximeter probe, and probe cable extender. These requirements also apply to pulse oximeter equipment, including pulse oximeter monitors, pulse oximeter probes and probe cable extenders, which have been reprocessed. The intended use of pulse oximeter equipment includes, but is not limited to, the estimation of arterial oxygen haemoglobin saturation and pulse rate of patients in professional healthcare institutions as well as patients in the home healthcare environment. ISO 80601-2-61:2011 is not applicable to pulse oximeter equipment intended for use in laboratory research applications nor to oximeters that require a blood sample from the patient. ISO 80601-2-61:2011 can also be applied to pulse oximeter equipment and their accessories used for compensation or alleviation of disease, injury or disability. ISO 80601-2-61:2011 is not applicable to pulse oximeter equipment intended solely for foetal use. ISO 80601-2-61:2011 is not applicable to remote or slave (secondary) devices that display SpO2 values that are located outside of the patient environment. |
| 국제분류(ICS)코드 | 11.040.10 : 마취제. 호흡 및 소생장비 |
| 페이지수 | 83 |
| Edition | 1 |
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | ISO 80601-2-61:2017 | Medical electrical equipment — Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment | 2017-12-15 | 표준 |
| 2 | ISO 80601-2-61:2011 | Medical electrical equipment — Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment | 2011-03-16 | 구판 |
| 3 | ISO/DIS 80601-2-61 | Medical electrical equipment — Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment | 초안 |
ISO/DIS 80601-2-61 - Medical electrical equipment — Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment 상세보기
ISO/DIS 80601-2-90 - Medical electrical equipment — Part 2-90: Particular requirements for basic safety and essential performance of respiratory high-flow therapy equipment 상세보기
ISO/DIS 80601-2-74 - Medical electrical equipment — Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment 상세보기
ISO/DIS 80601-2-70 - Medical electrical equipment — Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment 상세보기
ISO/DIS 80601-2-67 - Medical electrical equipment — Part 2-67: Particular requirements for basic safety and essential performance of oxygen-conserving equipment 상세보기
ISO 80601-2-56:2017/Amd 1:2018 - Medical electrical equipment — Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement — Amendment 1 상세보기
ISO 80601-2-61:2017 - Medical electrical equipment — Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment 상세보기
ISO 80601-2-56:2017 - Medical electrical equipment — Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement 상세보기
ISO 80601-2-69:2020 - Medical electrical equipment — Part 2-69: Particular requirements for the basic safety and essential performance of oxygen concentrator equipment 상세보기
ISO 80601-2-69:2014 - Medical electrical equipment — Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment 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
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