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    IEC 60601-2-27:2011

    Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
    • 발행일 : 2011-03-30
    • 발행기관 : IEC
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분야 TC 62/SC 62D : Particular medical equipment, software, and systems
적용범위 IEC 60601-2-27:2011 applies to electrocardiographic monitoring equipments used in a hospital environment as well as when used outside the hospital environment, such as in ambulances and air transport. This particular standard also applies to ECG telemetry systems used in a hospital environment. Electrocardiographic monitoring equipments intended for use under extreme or uncontrolled environmental conditions outside the hospital environment, such as in ambulances and air transport, shall comply with this particular standard. Additional standards may apply for those environments of use. This standard is not applicable to electrocardiographic monitors for home use. However, manufacturers should consider using relevant clauses of this standard as appropriate for their intended use. Ambulatory ("Holter") monitors, fetal heart rate monitoring, pulse plethysmographic devices, and other ECG recording equipment are outside the scope of this particular standard. The aim of this third edition is to bring this particular standard up to date with reference to the third edition of the general standard through reformatting and technical changes. The contents of the corrigendum of May 2012 have been included in this copy.
국제분류(ICS)코드 11.040.55 : 진단장비
페이지수 149
Edition 3.0

이력정보

No. 표준번호 표준명 발행일 상태
1 IEC 60601-2-27:2011/COR1:2012상세보기 Corrigendum 1 - Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment 2012-05-16 표준
2 IEC 60601-2-27:2011상세보기 Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment 2011-03-30 표준
3 IEC 60601-2-27:2005상세보기 Medical electrical equipment - Part 2-27: Particular requirements for the safety, including essential performance, of electrocardiographic monitoring equipment 2005-08-29 구판
4 IEC 60601-2-27:1994상세보기 Medical electrical equipment - Part 2: Particular requirements for the safety of electrocardiographic monitoring equipment 1994-04-13 구판

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