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    IEC 60601-2-50:2020+AMD1:2023 CSV

    Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment
    • 발행일 : 2023-10-26
    • 발행기관 : IEC
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분야 TC 62/SC 62D : Particular medical equipment, software, and systems
적용범위 IEC 60601-2-50:2020+AMD1:2023 CSV applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT PHOTOTHERAPY EQUIPMENT, as defined in 201.3.203, also referred to as ME EQUIPMENT. 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 7.2.13 and 8.4.1 of the general standard. IEC 60601-2-50:2020 specifies safety requirements for INFANT PHOTOTHERAPY EQUIPMENT, but alternate methods of compliance with a specific clause by demonstrating equivalent safety will not be judged as non-compliant if the MANUFACTURER has demonstrated in his RISK MANAGEMENT FILE that the RISK presented by the HAZARD has been found to be of an acceptable level when weighed against the benefit of treatment from the device.
IEC 60601-2-50:2020 does not apply to:
- devices supplying heat via BLANKETS, PADS or MATTRESSES in medical use; for information, see IEC 60601-2-35;
- INFANT INCUBATORS; for information, see IEC 60601-2-19;
- INFANT TRANSPORT INCUBATORS; for information, see IEC 60601-2-20;
- INFANT RADIANT WARMERS; for information, see IEC 60601-2-21.
IEC 60601-2-50:2020 cancels and replaces the second edition published in 2009 and Amendment 1:2016. This edition constitutes a technical revision. IEC 60601-2-50:2020 includes the following significant technical change with respect to the previous edition: re-dating of normative references.
국제분류(ICS)코드 11.040.60 : 치료장비
페이지수 123
Edition 3.1

이력정보

No. 표준번호 표준명 발행일 상태
1 IEC 60601-2-50:2020/AMD1:2023상세보기 Amendment 1 - Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment 2023-10-26 표준
2 IEC 60601-2-50:2020+AMD1:2023 CSV상세보기 Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment 2023-10-26 표준
3 IEC 60601-2-50:2020 RLV상세보기 Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment 2020-09-02 표준
4 IEC 60601-2-50:2020상세보기 Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment 2020-09-02 표준
5 IEC 60601-2-50:2009+AMD1:2016 CSV상세보기 Medical electrical equipment - Part 2-50: Particular requirementsfor the basic safety and essential performance of infant phototherapy equipment 2016-04-29 구판
6 IEC 60601-2-50:2009/AMD1:2016상세보기 Amendment 1 - Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment 2016-04-29 구판
7 IEC 60601-2-50:2009/COR1:2010상세보기 Corrigendum 1 - Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment 2010-08-10 구판
8 IEC 60601-2-50:2009상세보기 Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment 2009-03-24 구판
9 IEC 60601-2-50:2000/COR1:2001상세보기 Corrigendum 1 - Medical electrical equipment - Part 2-50: Particular requirements for the safety of infant phototherapy equipment 2001-03-29 구판
10 IEC 60601-2-50:2000상세보기 Medical electrical equipment - Part 2-50: Particular requirements for the safety of infant phototherapy equipment 2000-07-31 구판

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