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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)
분야 | 11 : LG Electronics |
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적용범위 | Preface This is the first edition of CAN/CSA-C22.2 No. 60601-1-10, 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, which is an adoption without modification of the identically titled IEC (International Electrotechnical Commission) Standard 60601-1-10 (first edition, 2007-11). It is one in a series of Standards issued by CSA under Part II of the Canadian Electrical Code. Scope, object and related standards 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 the development (analysis, design, VERIFICATION and VALIDATION) of a PHYSIOLOGIC CLOSED-LOOP CONTROLLER (PCLC) as part of a PHYSIOLOGIC CLOSED-LOOP CONTROL SYSTEM (PCLCS) in ME EQUIPMENT and ME SYSTEMS to control a PHYSIOLOGIC VARIABLE. NOTE A PHYSIOLOGIC VARIABLE can be a body chemistry (e.g. electrolytes, blood glucose), a physical property (e.g. PATIENT temperature, electrophysiologic, hemodynamic), or a pharmaceutical concentration. This collateral standard applies to various types of PCLC, e.g. linear and non-linear, adaptive, fuzzy, neural networks. This collateral standard does not specify: - additional mechanical requirements; or - additional electrical requirements. This collateral standard applies to a closed-loop controller (see Figure 1) that sets the CONTROLLER OUTPUT VARIABLE in order to adjust (i.e., change or maintain) the measured PHYSIOLOGIC VARIABLE by relating it to the REFERENCE VARIABLE. A closed-loop controller that maintains a physical or chemical VARIABLE, using feedback that is not measured from a PATIENT, is outside the scope of this standard. 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. 1.3 Related standards 1.3.1 IEC 60601-1 For ME EQUIPMENT and ME SYSTEMS, this collateral standard complements IEC 60601-1. When referring to IEC 60601-1 or to this collateral standard, either individually or in combination, the following conventions are used: - "the general standard" designates IEC 60601-1 alone; - "this collateral standard" designates IEC 60601-1-10 alone; - "this standard" designates the combination of the general standard and this collateral standard. ------------------------------------------------------------------------------------- Pr?face? Ce document constitue la premi?re ?dition de la CAN/CSA-C22.2 nº 60601-1-10, Appareils ?lectrom?dicaux - Partie 1-10 : Exigences g?n?rales pour la s?curit? de base et les performances essentielles - Norme collat?rale : Exigences pour le d?veloppement des r?gulateurs physiologiques en boucle ferm?e. Il s'agit de l'adoption, sans modifications, de la norme CEI (Commission ?lectrotechnique Internationale) 60601-1-10 (premi?re ?dition, 2007-11), qui porte le m?me titre. 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 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 pour le d?veloppement (analyse, conception, V?RIFICATION et VALIDATION) d'un R?GULATEUR PHYSIOLOGIQUE EN BOUCLE FERM?E (RPBF) en tant que partie d'un SYST?ME PHYSIOLOGIQUE DE COMMANDE EN BOUCLE FERM?E (SPCBF) dans les APPAREILS EM et les SYST?MES EM pour la commande d'une VARIABLE PHYSIOLOGIQUE. NOTE Une VARIABLE PHYSIOLOGIQUE peut ?tre un produit chimique du corps (par exemple ?lectrolytes, glyc?mie), une propri?t? physique (par exemple la temp?rature du patient, ?lectrophysiologique, h?modynamique) ou un solut? pharmaceutique. La pr?sente norme collat?rale s'applique aux diff?rents types de RPBF, par exemple lin?aire et non-lin?aire, adaptatifs, fuzzy, r?seaux de neurones. La pr?sente norme collat?rale ne sp?cifie pas - des exigences m?caniques additionnelles; ou - des exigences ?lectriques additionnelles. La pr?sente norme collat?rale s'applique ? un r?gulateur en boucle ferm?e (voir Figure 1) qui r?gle la VARIABLE DE SORTIE DU R?GULATEUR afin d'ajuster (c'est-?-dire, changer ou maintenir) la VARIABLE PHYSIOLOGIQUE mesur?e en effectuant une comparaison avec la VARIABLE DE R?F?RENCE. Un r?gulateur en boucle ferm?e qui maintient une VARIABLE physique ou chimique en utilisant une r?action dont la mesure n'a pas de liaison avec le PATIENT, ne fait pas partie du domaine d'application de la pr?sente norme. 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. 1.3 Normes connexes 1.3.1 CEI 60601-1 Pour les APPAREILS EM et les SYST?MES EM, la pr?sente norme collat?rale compl?te la CEI 60601-1. Lorsqu'il est fait r?f?rence ? la CEI 60601-1 ou ? la pr?sente norme collat?rale, soit individuellement soit combin?es, les conventions suivantes sont utilis?es: - "la norme g?n?rale" d?signe la CEI 60601-1 seule; - "la pr?sente norme collat?rale" d?signe la CEI 60601-1-10 seule; - "la pr?sente norme" d?signe la combinaison de la norme g?n?rale et de la pr?sente norme collat?rale. |
국제분류(ICS)코드 | |
페이지수 | 102 |
Edition |
No. | 표준번호 | 표준명 | 발행일 | 상태 |
---|---|---|---|---|
1 | CSA C22.2 NO. 60601-1-10:09 + A1:14 (R2020) + A2:21 (CONSOLIDATED) | 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, edition 1:2007 consolida | 2022-01-01 | 표준 |
2 | 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) | 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. 60601-1-3:09 (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. 60601-2-44:10 (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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