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ISO 80601-2-55:2018
Medical electrical equipment — Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors- 발행일 : 2018-02-12
- 발행기관 : ISO
상세정보
| 분야 | ISO/TC 121/SC 1 : Breathing attachments and anaesthetic machines |
|---|---|
| 적용범위 | ISO 80601-2-55:2018 specifies particular requirements for the basic safety and essential performance of a respiratory gas monitor (rgm), hereafter referred to as me equipment, intended for continuous operation for use with a patient. ISO 80601-2-55:2018 specifies requirements for - anaesthetic gas monitoring, - carbon dioxide monitoring, and - oxygen monitoring. NOTE 1 An rgm can be either stand-alone me equipment or integrated into other equipment, e.g. an anaesthetic workstation or a ventilator. ISO 80601-2-55:2018 is not applicable to an rgm intended for use with flammable anaesthetic agents. 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 IEC 60601‑1:2005+Amd 1:2012, 7.2.13 and 8.4.1. NOTE 2 Additional information can be found in IEC 60601‑1:2005+Amd 1:2012, 4.2. |
| 국제분류(ICS)코드 | 11.040.10 : 마취제. 호흡 및 소생장비 |
| 페이지수 | 59 |
| Edition | 2 |
이력정보
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | ISO 80601-2-55:2018/Amd 1:2023상세보기 | Medical electrical equipment — Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors — Amendment 1 | 2023-12-06 | 표준 |
| 2 | ISO 80601-2-55:2018상세보기 | Medical electrical equipment — Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors | 2018-02-12 | 표준 |
| 3 | ISO 80601-2-55:2011상세보기 | Medical electrical equipment — Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors | 2011-12-15 | 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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- ASTM F384-17 - Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices
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- ASTM F2502-17 - Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants
- ASTM F564-17 - Standard Specification and Test Methods for Metallic Bone Staples
추천 상품
- IEC TS 63134:2020 - Active assisted living (AAL) use cases
- 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
- KS B ISO TS 25740-1 - 에스컬레이터 및 무빙워크에 대한 안전요건 — 제1부: 세계공통 필수 안전요건(GESRs)
- KS B ISO TS 8100-21 - 승객 및 화물 운송용 엘리베이터 —제21부: 세계공통 필수안전요건(GESRs)을 충족하는 세계공통 안전 파라미터(GSPs)
- KS C IEC TS 62872 - 산업 시설과 스마트 그리드 사이의 산업 공정 측정, 제어 및 자동화 시스템 인터페이스
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