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ISO 80601-2-12:2011
Medical electrical equipment — Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators- 발행일 : 2011-04-07
- 발행기관 : ISO
상세정보
| 분야 | ISO/TC 121/SC 3 : Respiratory devices and related equipment used for patient care |
|---|---|
| 적용범위 | ISO 80601-2-12:2011 applies to the basic safety and essential performance of a ventilator in combination with its accessories, hereafter referred to as me equipment:
ISO 80601-2-12:2011 is also applicable to those accessories intended by their manufacturer to be connected to a breathing system, or to a ventilator, where the characteristics of those accessories can affect the basic safety or essential performance of the ventilator. ISO 80601-2-12:2011 is not applicable to me equipment or an me system operating in ventilation modes intended for patients who are not dependent on mechanical ventilation. ISO 80601-2-12:2011 is not applicable to me equipment or an me system intended for those patients who are not dependent on mechanical ventilation. 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. ISO 80601-2-12:2011 is not applicable to continuous positive airway pressure (CPAP) me equipment, sleep apnoea therapy me equipment, home healthcare environment ventilators, ventilatory support me equipment, emergency and transport ventilators, anaesthetic ventilators, high-frequency jet ventilators (HFJVs) and high-frequency oscillatory ventilators (HFOVs). ISO 80601-2-12:2011 does not specify the requirements for me equipment that is intended solely to augment the ventilation of spontaneously breathing patients within a professional healthcare facility. ISO 80601-2-12:2011 does not specify the requirements for ventilators or accessories intended for anaesthetic applications which are given in ISO 80601-2-13. ISO 80601-2-12:2011 does not specify the requirements for ventilators or accessories intended for home care ventilators for ventilator-dependent patients which are given in ISO 10651-2. ISO 80601-2-12:2011 does not specify the requirements for ventilators or accessories intended for emergency and transport which are given in ISO 10651-3. ISO 80601-2-12:2011 does not specify the requirements for ventilators or accessories intended for home-care ventilatory support devices which are given in ISO 10651-6. |
| 국제분류(ICS)코드 | 11.040.10 : 마취제. 호흡 및 소생장비 |
| 페이지수 | 78 |
| Edition | 1 |
이력정보
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | ISO 80601-2-12:2023상세보기 | Medical electrical equipment — Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators | 2023-11-03 | 표준 |
| 2 | ISO 80601-2-12:2020상세보기 | Medical electrical equipment — Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators | 2020-02-25 | 구판 |
| 3 | ISO 80601-2-12:2011/Cor 1:2011상세보기 | 2011-10-11 | 구판 | |
| 4 | ISO 80601-2-12:2011상세보기 | Medical electrical equipment — Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators | 2011-04-07 | 구판 |
관련상품
- ISO/DIS 80601-2-61 - Medical electrical equipment — Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
- 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
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추천 상품
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- KS C IEC TS 62872 - 산업 시설과 스마트 그리드 사이의 산업 공정 측정, 제어 및 자동화 시스템 인터페이스
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