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IEC 80601-2-49:2018
Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors- 발행일 : 2018-03-08
- 발행기관 : IEC
상세정보
| 분야 | TC 62/SC 62D : Particular medical equipment, software, and systems |
|---|---|
| 적용범위 | IEC 80601-2-49:2018 applies to basic safety and essential performance requirements of multifunction patient monitors, hereafter referred to as ME equipment or medical electrical systems. This particular standard applies to multifunction patient monitors intended for use in professional healthcare facilities as well as in the emergency medical service environment or the home healthcare environment. The scope of this document is restricted to ME equipment or medical electrical systems intended for connection to a single patient that has two or more physiological monitoring units. For purposes of this document, a pregnant mother and her fetus(es) are considered a single patient. This document does not specify requirements for individual physiological monitoring units such as ECG, invasive pressure and pulse oximetry. The particular standards related to these physiological monitoring units specify requirements from the perspective of stand-alone ME equipment. This particular standard addresses the additional requirements related to multifunction patient monitors. Multifunction patient monitors can be integrated into other ME equipment or medical electrical systems. When this is the case, other relevant standards also apply. This document does not apply to implantable parts of multifunction patient monitors. This first edition cancels and replaces the second edition of IEC 60601-2-49, published in 2011. This edition constitutes a technical revision to align with the current edition and Amendment to IEC 60601-1, new versions of collateral standards and amendments thereto. Major changes are in Clause 208 because many of the former requirements are now addressed by IEC 60601-1-8. |
| 국제분류(ICS)코드 | 11.040.55 : 진단장비 |
| 페이지수 | 83 |
| Edition | 1.0 |
이력정보
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | IEC 80601-2-49:2018/AMD1:2024상세보기 | Amendment 1 - Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors | 2024-09-11 | 표준 |
| 2 | IEC 80601-2-49:2018+AMD1:2024 CSV상세보기 | Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors | 2024-09-11 | 표준 |
| 3 | IEC 80601-2-49:2018상세보기 | Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors | 2018-03-08 | 표준 |
관련상품
- IEC 80601-2-60:2019/DAmd 1 - Medical electrical equipment — Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment — Amendment 1
- IEC/DIS 80601-2-89 - Medical electrical equipment — Part 2-89: Particular requirements for the basic safety and essential performance of medical beds for children
- IEC/DIS 80601-2-52 - Medical electrical equipment — Part 2-52: Particular requirements for the basic safety and essential performance of medical beds
- IEC/DIS 80601-2-31 - Medical electrical equipment — Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
- IEC/DIS 80601-2-23 - Medical electrical equipment — Part 2-23: Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment
다른 사람이 함께 구입한 상품
- IEC 60601-2-27:2011 - Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
- IEC 60601-2-27:2011/COR1:2012 - Corrigendum 1 - Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
- KS C IEC 80601-2-49 - 의료용 전기기기 — 제2-49부: 다기능 환자 감시장치의 기본 안전 및 필수 성능에 대한 개별 요구사항
- IEC 80601-2-60:2019 - Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment
- IEC 80601-2-26:2019 - Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs
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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