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ISO 80601-2-13:2011
Medical electrical equipment — Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation- 발행일 : 2011-08-08
- 발행기관 : ISO
상세정보
| 분야 | ISO/TC 121/SC 1 : Breathing attachments and anaesthetic machines |
|---|---|
| 적용범위 | ISO/IEC 80601-2-13:2011 is applicable to the basic safety and essential performance of an anaesthetic workstation for administering inhalational anaesthesia whilst continuously attended by a professional operator. ISO/IEC 80601-2-13:2011 specifies particular requirements for a complete anaesthetic workstation and the following anaesthetic workstation components which, although considered as individual devices in their own right, may be utilized, in conjunction with other relevant anaesthetic workstation components, to form an anaesthetic workstation to a given specification:
ISO/IEC 80601-2-13:2011 is also applicable to those accessories intended by their manufacturer to be connected to an anaesthetic workstation where the characteristics of those accessories can affect the basic safety and essential performance of the anaesthetic workstation. If a clause or subclause is specifically intended to be applicable to anaesthetic workstation components 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 an anaesthetic workstation and its individual components, as relevant. Hazards inherent in the intended physiological function of an anaesthetic workstation and its individual components within the scope of ISO/IEC 80601-2-13:2011 are not covered by specific requirements in ISO/IEC 80601-2-13:2011 except in 7.2.13 and 8.4.1 of IEC 60601-1:2005. ISO/IEC 80601-2-13:2011 is not applicable to any anaesthetic workstation intended for use with flammable anaesthetic agents, as determined by Annex BB. |
| 국제분류(ICS)코드 | 11.040.10 : 마취제. 호흡 및 소생장비 |
| 페이지수 | 99 |
| Edition | 1 |
이력정보
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | ISO 80601-2-13:2022상세보기 | Medical electrical equipment — Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation | 2022-04-29 | 표준 |
| 2 | ISO 80601-2-13:2011/Amd 2:2018상세보기 | Medical electrical equipment — Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation — Amendment 2 | 2018-07-19 | 구판 |
| 3 | ISO 80601-2-13:2011/Amd 1:2015상세보기 | Medical electrical equipment — Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation — Amendment 1 | 2015-03-06 | 구판 |
| 4 | ISO 80601-2-13:2011상세보기 | Medical electrical equipment — Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation | 2011-08-08 | 구판 |
| 5 | ISO 80601-2-13:2022/DAmd 1상세보기 | Medical electrical equipment — Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation — Amendment 1 | 초안 |
관련상품
- 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 80601-2-13:2022/DAmd 1 - Medical electrical equipment — Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation — Amendment 1
- 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
다른 사람이 함께 구입한 상품
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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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