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ISO/DIS 80601-2-61
Medical electrical equipment — Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment- 발행일 :
- 발행기관 : ISO
상세정보
| 분야 | ISO/TC 121/SC 3 : Respiratory devices and related equipment used for patient care |
|---|---|
| 적용범위 | ISO 80601-2-61:2017 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 and the emergency medical services environment. ISO 80601-2-61:2017 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. If a clause or subclause is specifically intended to be applicable to me equipment only, or to me systems only, the title and 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 relevant. 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 201.11 and in 7.2.13 and 8.4.1 of the general standard. NOTE 1 See also 4.2 of the general standard. "The general standard" is IEC 60601-1:2005+AMD1:2012, Medical electrical equipment ? Part 1: General requirements for basic safety and essential performance. ISO 80601-2-61:2017 can also be applied to me equipment and their accessories used for compensation or alleviation of disease, injury or disability. ISO 80601-2-61:2017 is not applicable to pulse oximeter equipment intended solely for foetal use. ISO 80601-2-61:2017 is not applicable to remote or slave (secondary) equipment that displays SpO2 values that are located outside of the patient environment. NOTE 2 Me equipment that provides selection between diagnostic and monitoring functions is expected to meet the requirements of the appropriate document when configured for that function. ISO 80601-2-61:2017 is applicable to pulse oximeter equipment intended for use under extreme or uncontrolled environmental conditions outside the hospital environment or physician's office, such as in ambulances and air transport. Additional standards can apply pulse oximeter equipment for those environments of use. ISO 80601-2-61:2017 is a particular standard in the IEC 60601-1 and ISO/IEC 80601 series of standards. |
| 국제분류(ICS)코드 |
11.040.10 : 마취제. 호흡 및 소생장비
11.040.55 : 진단장비 |
| 페이지수 | 140 |
| Edition | 3 |
이력정보
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | ISO 80601-2-61:2017상세보기 | Medical electrical equipment — Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment | 2017-12-15 | 표준 |
| 2 | ISO 80601-2-61:2011상세보기 | 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 80601-2-61상세보기 | Medical electrical equipment — Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment | 초안 |
관련상품
- 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
- ISO/DIS 80601-2-74 - Medical electrical equipment — Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment
- 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
- ISO/DIS 80601-2-67 - Medical electrical equipment — Part 2-67: Particular requirements for basic safety and essential performance of oxygen-conserving equipment
- ISO/DIS 80601-2-69 - Medical electrical equipment — Part 2-69: Particular requirements for the basic safety and essential performance of oxygen concentrator equipment
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