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IEC 60601-2-47:2012
Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems- 발행일 : 2012-02-16
- 발행기관 : IEC
상세정보
| 분야 | TC 62/SC 62D : Particular medical equipment, software, and systems |
|---|---|
| 적용범위 | IEC 60601-2-47:2012 concerns the basic safety and essential performance of AMBULATORY ELECTROCARDIOGRAPHIC SYSTEMS. It amends and supplements the general standard IEC 60601-1 (third edition 2005). The requirements of this particular standard take priority over those of the general standard. Within the scope of this standard are systems of the following types: a) systems that provide continuous recording and continuous analysis of the ECG allowing full re-analysis giving essentially similar results. b) systems that provide continuous analysis and only partial or limited recording not allowing a full re-analysis of the ECG. The safety aspects of this standard apply to all types of systems falling in one of the above- mentioned categories. If the AMBULATORY ELECTROCARDIOGRAPHIC SYSTEM offers automatic ECG analysis, minimal performance requirements for measurement and analysis functions apply. MEDICAL ELECTRICAL EQUIPMENT covered by IEC 60601-2-25 and IEC 60601-2-27 are excluded from the scope of this standard. This standard does not apply to systems that do not continuously record and analyse the ECG (for example, 'intermittent event recorders'). This second edition cancels and replaces the first edition published in 2001. It constitutes a technical revision. This edition was revised to align structurally with the 2005 edition of IEC 60601-1. |
| 국제분류(ICS)코드 | 11.040.55 : 진단장비 |
| 페이지수 | 135 |
| Edition | 2.0 |
이력정보
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | IEC 60601-2-47:2012상세보기 | Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems | 2012-02-16 | 표준 |
| 2 | IEC 60601-2-47:2001상세보기 | Medical electrical equipment - Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems | 2001-07-10 | 구판 |
관련상품
- IEC/DIS 60601-2-26 - Medical electrical equipment — Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs
- IEC 60601-2-15:1988 - Medical electrical equipment. Part 2: Particular requirements for the safety of capacitor discharge X-ray generators
- IEC 60601-2-14:1989 - Medical electrical equipment. Part 2: Particular requirements for the safety of electroconvulsive therapy equipment
- IEC 60601-2-32:1994 - Medical electrical equipment - Part 2: Particular requirements for the safety of associated equipment of X-ray equipment
- IEC 60601-1-4:1996 - Medical electrical equipment - Part 1: General requirements for safety - 4. Collateral standard: Programmable electrical medical systems
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 60601-2-25:2011 - Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
- BS EN 60601-2-10:2015+A1:2016 - Medical electrical equipment. Particular requirements for the basic safety and essential performance of nerve and muscle stimulators.
- IEC 60601-2-34:2011 - Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment
- IEC 60601-2-83:2019 - Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment
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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