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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
분야 | 11 : LG Electronics |
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적용범위 | Preface This is the second edition of CAN/CSA-C22.2 No. 60601-1-3, Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment, which is an adoption without modification of the identically titled IEC (International Electrotechnical Commission) Standard 60601-1-3 (second edition, 2008-01). It supersedes the previous edition published in 1998 as CAN/CSA-C22.2 No. 601.1.3 (adopted CEI/IEC 601-1-3:1994). It is one in a series of Standards issued by CSA under Part II of the Canadian Electrical Code. Scope, object and related standards 1. Scope This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS. This collateral standard applies to X-RAY EQUIPMENT and to subassemblies of such equipment, where RADIOLOGICAL IMAGES of a human PATIENT are used for diagnosis, planning or guidance of medical procedures. 1.2 Object The object of this collateral standard is to specify general requirements that are in addition to those of the general standard and to serve as the basis for particular standards. The object of this collateral standard is to establish general requirements for protection against X-RADIATION in X-RAY EQUIPMENT, in order that the IRRADIATION of the human PATIENT, the OPERATOR, staff and members of the public can be kept as low as reasonably achievable, without jeopardizing the benefit of the RADIOLOGICAL procedure. Particular standards may specify their appropriate values and/or measures for general requirements specified in this collateral standard. The implementation of the general requirements or the reference to the particular standard instead, shall be justified in the RISK MANAGEMENT process. This collateral standard considers RADIATION PROTECTION aspects related to X-RADIATION only. Requirements for the control of the electrical energy used to generate X-RADIATION, which is also an important aspect of RADIATION PROTECTION, are included in IEC 60601-1 and in particular standards for the safety and ESSENTIAL PERFORMANCE of the EQUIPMENT concerned. ---------------------------------------------------------------------------------------------------------------------- Pr?face? Ce document constitue la deuxi?me ?dition de la CAN/CSA-C22.2 nº 60601-1-3, Appareils ?lectrom?dicaux - Partie 1-3 : Exigences g?n?rales pour la s?curit? de base et les performances essentielles - Norme collat?rale : Radioprotection dans les appareils ? rayonnement X de diagnostic. Il s'agit de l'adoption, sans modifications, de la norme CEI (Commission ?lectrotechnique Internationale) 60601-1-3 (deuxi?me ?dition, 2008-01), qui porte le m?me titre. Cette norme remplace l'?dition pr?c?dente publi?e en 1998 qui portait la d?signation CAN/CSA-C22.2 nº 601.1.3 (norme CEI/IEC 601-1-3:1994 adopt?e). Cette norme fait partie d'une s?rie de normes publi?es par CSA lesquelles constituent le Code canadien de l'?lectricit?, Deuxi?me partie. Domaine d'application, objet et normes connexes 1. Domaine d’application La pr?sente norme internationale s'applique ? la SECURITE DE BASE et aux PERFORMANCES ESSENTIELLES des APPAREILS et des SYSTEMES ELECTROMEDICAUX, d?sign?s ci-apr?s sous le terme APPAREILS et SYSTEMES EM. La pr?sente norme collat?rale s'applique aux APPAREILS A RAYONNEMENT X et ? leurs sousensembles, dont les IMAGES RADIOLOGIQUES d'un PATIENT humain sont utilis?es ? des fins de diagnostic, de planification ou de guide pour les proc?dures m?dicales. 1.2 Objet La pr?sente Norme collat?rale est destin?e ? sp?cifier des exigences g?n?rales qui viennent compl?ter celles de la norme g?n?rale et ? servir de base pour les normes Particuli?res. L'objet de la pr?sente norme collat?rale est d'?tablir des exigences g?n?rales pour la protection contre les RAYONNEMENTS X dans les APPAREILS A RAYONNEMENT X, afin que l'IRRADIATION des PATIENTS humains, de l'OPERATEUR, des membres de l'?quipe m?dicale et des autres personnes pr?sentes puisse ?tre maintenue ? un niveau aussi bas que raisonnablement possible, sans compromettre le b?n?fice de la proc?dure RADIOLOGIQUE. Des normes particuli?res peuvent sp?cifier des valeurs et/ou mesures qui leur sont appropri?es par rapport aux exigences g?n?rales sp?cifi?es dans la pr?sente norme collat?rale. La mise en oeuvre des exigences g?n?rales ou, ? la place, la r?f?rence ? la norme particuli?re doit ?tre justifi?e dans le processus DE GESTION DES RISQUES. La pr?sente norme collat?rale traite des aspects de RADIOPROTECTION li?s aux RAYONNEMENTS X uniquement. Les exigences pour la commande de l'?nergie ?lectrique utilis?e pour produire le RAYONNEMENT X, qui est aussi un aspect important de la RADIOPROTECTION, figurent dans la CEI 60601-1 et dans les normes particuli?res pour la s?curit? et les PERFORMANCES ESSENTIELLES des APPAREILS concern?s. |
국제분류(ICS)코드 | |
페이지수 | 121 |
Edition |
No. | 표준번호 | 표준명 | 발행일 | 상태 |
---|---|---|---|---|
1 | CSA C22.2 NO. 60601-1-3:09 + A1:15 (R2019) + A2:22 (CONSOLIDATED) | 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, edition 2:2008 consolidated with amendment 1:2013 | 2022-01-01 | 표준 |
2 | 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 | 2009-01-01 | 표준 |
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 상세보기
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. 60601-1-10:09 (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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