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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
분야 | 11 : LG Electronics |
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적용범위 | CSA Preface This is the second edition of CAN/CSA-C22.2 No. 60601-1-8, 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, which is an adoption without modification of the identically titled IEC (International Electrotechnical Commission) Standard 60601-1-8 (second edition, 2006-10). It supersedes the previous edition published in 2005 as CAN/CSA-C22.2 No. 60601-1-8, Medical electrical equipment - Part 1-8: General requirements for safety - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems (adopted IEC 60601-1-8:2005). It is one in a series of Standards issued by CSA under Part II of the Canadian Electrical Code. 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 specifies requirements for ALARM SYSTEMS and ALARM SIGNALS in ME EQUIPMENT and ME SYSTEMS. It also provides guidance for the application of ALARM SYSTEMS. ------------------------------------------------------------------------------------------------------------ Pr?face? CSA Ce document constitue la deuxi?me ?dition de la CAN/CSA-C22.2 nº 60601-1-8, Appareils ?lectrom?dicaux - Partie 1-8 : Exigences g?n?rales pour la s?curit? de base et les performances essentielles - Norme collat?rale : Exigences g?n?rales, essais et guide pour les syst?mes d'alarme des appareils et des syst?mes ?lectrom?dicaux. Il s'agit de l'adoption, sans modifications, de la norme CEI (Commission ?lectrotechnique Internationale) 60601-1-8 (deuxi?me ?dition, 2006-10), qui porte le m?me titre. Cette norme remplace l'?dition pr?c?dente publi?e en 2005 et intitul?e CAN/CSA-C22.2 nº 60601-1-8, Appareils ?lectrom?dicaux - Partie 1-8 : R?gles g?n?rales de s?curit? - Norme collat?rale : R?gles g?n?rales, essais et recommendations pour les syst?mes d'alarme des appareils et des syst?mes ?lectrom?dicaux (norme CEI 60601-1-8:2005 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 La pr?sente Norme internationale s'applique ? la S?CURIT? DE BASE et aux PERFORMANCES ESSENTIELLES des APPAREILS ?LECTROM?DICAUX et des SYST?MES ?LECTROM?DICAUX, d?sign?s ci-apr?s sous le terme APPAREILS EM et SYST?MES EM. La pr?sente norme collat?rale sp?cifie les exigences applicables aux SYST?MES D'ALARME et aux SIGNAUX D'ALARME des APPAREILS ET DES SYST?MES EM. Elle donne ?galement des lignes directrices pour l'application des SYST?MES D'ALARME. |
국제분류(ICS)코드 | |
페이지수 | 179 |
Edition |
No. | 표준번호 | 표준명 | 발행일 | 상태 |
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1 | CAN/CSA-C22.2 NO. 60601-1-8:08 + A1:14 + A2:21 (R2023) (CONSOLIDATED) | 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 | 2022-01-01 | 표준 |
2 | 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 | 2008-01-01 | 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
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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