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Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
| 분야 | TC 62/SC 62D : Particular medical equipment, software, and systems |
|---|---|
| 적용범위 | IEC 60601-2-25:2011 applies to the basic safety and essential performance of electrocardiographs intended by themselves or as a part of a medical electrical system, for the production of electrocardiogram reports for diagnostic purposes. The equipment intended for use under extreme or uncontrolled environmental conditions outside the hospital environment or physician's office, such as in ambulances and air transport, shall comply with this particular standard. Additional standards may apply to Medical electrical equipment for those environments of use. Not included within the scope of this particular standard are: a) the part of Medical electrical equipment that provides vectorcardiographic loops; b) ambulatory electrocardiographic medical electrical equipment covered by IEC 60601-2-47 where not intended for obtaining electrocardiogram reports for diagnostic purposes; c) cardiac monitors covered by IEC 60601-2-27 where not intended for obtaining electrocardiographic reports for diagnostic purposes. This second edition cancels and replaces the first edition of IEC 60601-2-25, published in 1993 and the first edition of IEC 60601-2-51, published in 2003. Updating the particular standards to refer to the third edition of the general standard provided the opportunity to merge the first editions of IEC 60601-2-25 and IEC 60601-2-51 into one standard. Reformatting and technical changes were both made. This second edition of IEC 60601-2-25 constitutes a technical revision of both those standards. |
| 국제분류(ICS)코드 |
11.040.99 : 기타 의료장비
11.040.55 : 진단장비 |
| 페이지수 | 196 |
| Edition | 2.0 |
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | IEC 60601-2-25:2011 | Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs | 2011-10-19 | 표준 |
| 2 | IEC 60601-2-25:1993/AMD1:1999 | Amendment 1 - Medical electrical equipment - Part 2-25: Particular requirements for the safety of electrocardiographs | 1999-05-07 | 구판 |
| 3 | IEC 60601-2-25:1993 | Medical electrical equipment - Part 2: Particular requirements for the safety of electrocardiographs | 1993-03-19 | 구판 |
IEC/DIS 60601-2-26 - Medical electrical equipment — Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs 상세보기
IEC 60601-2-15:1988 - Medical electrical equipment. Part 2: Particular requirements for the safety of capacitor discharge X-ray generators 상세보기
IEC 60601-2-14:1989 - Medical electrical equipment. Part 2: Particular requirements for the safety of electroconvulsive therapy equipment 상세보기
IEC 60601-2-32:1994 - Medical electrical equipment - Part 2: Particular requirements for the safety of associated equipment of X-ray equipment 상세보기
IEC 60601-1-4:1996 - Medical electrical equipment - Part 1: General requirements for safety - 4. Collateral standard: Programmable electrical medical systems 상세보기
IEC 60601-2-18:2009 - Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment 상세보기
IEC 60601-2-27:2011 - Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment 상세보기
IEC 60601-2-47:2012 - Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems 상세보기
IEC 62304:2006+AMD1:2015 CSV - Medical device software - Software life cycle processes 상세보기
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IEC TS 63134:2020 - Active assisted living (AAL) use cases 상세보기
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