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Medical Electrical Equipment - Part 2: Particular Requirements for the Safety of Electrically Operated Hospital Beds (Adopted CEI/IEC 601-2-38:1996, first edition, 1996-10, including Amendment 1:1999) | Appareils électromédicaux - Partie 2: Règles particu
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적용범위 | 1. Scope and object This clause of the General Standard applies, except as follows: ? 1. Scope Addition: This Particular Standard specifies requirements for safety of ELECTRICALLY OPERATED HOSPITAL BEDS, hereinafter referred to as BED, as defined in 2.2.101.? 1.2 Object Replacement: The object of this Particular Standard for BEDS is to keep the SAFETY HAZARDS to PATIENTS, OPERATORS, and the environment as low as possible, and to describe tests to verify that these requirements are attained.? 1.3 Particular Standards Addition: This Particular Standard amends and supplements a set of IEC publications, hereinafter referred to as "General Standard", consisting of IEC 601-1: 1988, Medical electrical equipment - Part 1: General requirements for safety, amendment 1, amendment 2 and IEC 601-1-1: 1992, Medical electrical equipment - Part 1 : General requirements for safety 1 - Collateral Standard: Safety requirements for medical electrical systems.? For brevity, IEC 601-1 is referred to in this Particular Standard either as the "General Standard" or as the "General Requirement(s)", and IEC 601-1-1 as the "Collateral Standard". The term "this Standard" covers the Particular Standard, used together with the General Standard and any Collateral Standards. The numbering of sections, clauses and subclauses of this Particular Standard corresponds with that of the General Standard. The changes to the text of the General Standard are specified by the use of the following words: "Replacement" means that the clause or subclause of the General Standard is replaced completely by the text of this Particular Standard. "Addition" means that the text of this Particular Standard is additional to the requirements of the General Standard. "Amendment" means that the clause or subclause of the General Standard is amended as indicated by the text of this Particular Standard.? Subclauses or figures which are additional to those of the General Standard are numbered starting from 101, additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc.? Clauses and subclauses to which there is a rationale are marked with an asterisk.? These rationales can be found in an informative annex AA. Annex AA should be used in determining the relevance of the requirements addressed, but should never be used to establish additional test requirements.? Where there is no corresponding section, clause or subclause in this Particular Standard, the section, clause or subclause of the General Standard or the Collateral Standard applies without modification. Where it is intended that any part of the General Standard or the Collateral Standard, although possibly relevant, is not to be applied, a statement to that effect is given in this Particular Standard.? A requirement of this Particular Standard replacing or modifying requirements of the General Standard or the Collateral Standard takes precedence over the corresponding General Requirement(s). ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- ? 1. Domaine d’application et objet L'article correspondant de la Norme G?n?rale s'applique avec les exceptions suivantes:? ? 1. Domaine d’application Compl?ment: La pr?sente Norme Particuli?re sp?cifie les r?gles de s?curit? relative aux LITS D'H?PITAL ?LECTRIQUES, en abr?g? LIT dans la pr?sente Norme Particuli?re (voir 2.2.101).? 1.2 Objet Remplacement: L'objet de la pr?sente Norme Particuli?re relative aux LITS est de minimiser autant que possible les RISQUES pour les PATIENTS, les OP?RATEURS et l'environnement, et de d?crire les essais servant ? v?rifier que les prescriptions sont satisfaites.? 1.3 Normes Particuli?res Compl?ment: La pr?sente Norme Particuli?re modifie et compl?te un ensemble de publications de la CEI, en abr?g? ?Norme G?n?rale? dans la pr?sente Norme Particuli?re, se composant de la publication CEI 601-1: 1988, Appareils ?lectrom?dicaux - Premi?re partie: R?gles g?n?rales de s?curit?, de l'amendement 1, de l'amendement 2 et de la publication CEI 601-1-1: 1992, Appareils ?lectrom?dicaux - Premi?re partie: R?gles g?n?rales de s?curit? - Norme Collat?rale: R?gles de s?curit? pour syst?mes ?lectrom?dicaux. Pour plus de concision, la CEI 601-1 est d?sign?e dans la pr?sente Norme Particuli?re soit comme ?Norme G?n?rale? soit comme ?Prescription(s) G?n?rale(s)? et la publication CEI 601-1-1 est d?sign?e comme ?Norme Collat?rale?. 'expression ?pr?sente Norme Particuli?re? signifie la Norme Particuli?re appliqu?e en combinaison avec la Norme G?n?rale et n'importe quelle Norme Collat?rale. La num?rotation des sections, articles et paragraphes de la pr?sente Norme Particuli?re correspond ? celle de la Norme G?n?rale. Les modifications apport?es au texte de la Norme G?n?rale sont indiqu?es par l'emploi des mots suivants: ?Remplacement? signifie que l'article ou le paragraphe correspondant de la Norme G?n?rale est compl?tement remplac? par le texte de la pr?sente Norme Particuli?re. ?Compl?ment? signifie que le texte de la pr?sente Norme Particuli?re doit ?tre ajout? aux prescriptions de la Norme G?n?rale. ?Modification? signifie que l'article ou le paragraphe de la Norme G?n?rale est modifi? ainsi qu'indiqu? dans la pr?sente Norme Particuli?re.? Les paragraphes ou figures compl?mentaires ? ceux de la Norme G?n?rale sont num?rot?s ? partir de 101, les annexes compl?mentaires sont identifi?es AA, BB, etc., et les points compl?mentaires sont identifi?s aa), bb), etc.? Les articles et paragraphes faisant l'objet de justifications sont marqu?s d'un ast?risque.? Ces justifications se trouvent dans l'annexe AA. L.annexe AA peut ?tre utilis?e pour d?terminer la pertinence des prescriptions consid?r?es, mais elle ne peut en aucun cas ?tre utilis?e dans le but de sp?cifier des prescriptions d'essai compl?mentaires.? Lorsque la pr?sente Norme Particuli?re ne comprend pas de section, d'article ou de paragraphe, la section, l'article ou le paragraphe de la Norme G?n?rale ou de la Norme Collat?rale s'applique sans modification. Lorsqu'il est demand? qu'une partie quelconque de la Norme G?n?rale ou de la Norme Collat?rale, bien que pertinente, ne s'applique pas, cela est express?ment mentionn? dans la pr?sente Norme Particuli?re.? Une prescription de la pr?sente Norme Particuli?re rempla?ant ou modifiant des prescriptions de la Norme G?n?rale ou de la Norme Collat?rale a priorit? sur la (ou les) Prescription(s) G?n?rale(s). |
국제분류(ICS)코드 | |
페이지수 | 110 |
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No. | 표준번호 | 표준명 | 발행일 | 상태 |
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1 | CAN/CSA-C22.2 NO. 60601-2-38-03 (R2007) | Medical Electrical Equipment - Part 2: Particular Requirements for the Safety of Electrically Operated Hospital Beds (Adopted CEI/IEC 601-2-38:1996, first edition, 1996-10, including Amendment 1:1999) | Appareils électromédicaux - Partie 2: Règles particu | 2003-01-01 | 표준 |
CAN/CSA-C22.2 NO. 60601-1-8:08 (R2023) - Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems (Adop 상세보기
CSA C22.2 NO. 60601-2-37:08 (R2023) - Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment (Adopted IEC 60601-2-37:2007, second edition, 2007-08) | Appareils électromédicaux - 상세보기
CSA C22.2 NO. 60601-1-3:09 (R2019) - Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral standard: Radiation protection in diagnostic X-ray equipment (Adopted IEC 60601-1:2008, second edition, 2008-01) | Appareils électromédic 상세보기
CSA C22.2 NO. 60601-1-10:09 (R2020) - Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers (Adopted IEC 60601-1-10:2007, first edition, 2007-11) 상세보기
CSA C22.2 NO. 60601-2-44:10 (R2019) - Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography (Adopted IEC 60601-2-44:2009, third edition, 2009-02) | Appareils électromédicaux - Partie 2-44: Ex 상세보기
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