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      • CSA C22.2 NO. 80601-2-30:19

      Codes & Standards - Purchase

      CSA C22.2 NO. 80601-2-30:19

      Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers (Adopted IEC 80601-2-30:2018, second edition, 2018-03) | Appareils électromédicaux - Partie 2-30: Exigences particulières pour la sécurité de base et les performances essentielles des sphygmomanomètres non invasifs automatiques (norme IEC 80601-2-30:2018 adoptée, deuxième édition, 2018-03)

      SKU: 2427699 Published by CSA Group Publication Year 2019 Reaffirmed in 2015 147 pages

      Product Details

      • Preface/Scope
      • Editions

      CSA Preface


      This is the second edition of CSA C22.2 No. 80601-2-30, Medical electrical equipment — Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers, which is an adoption, with Canadian deviations, of the identically titled IEC (International Electrotechnical Commission) Standard 80601-2-30 (second edition, 2018-03). It supersedes the previous edition, published in 2010 as CAN/CSA-C22.2 No. 80601-2-30 (adopted IEC 80601-2-30:2009). It is one in a series of Standards issued by CSA Group under Part II of the Canadian Electrical Code.


      For brevity, this Standard will be referred to as CSA C22.2 No. 80601-2-30 throughout.


      This Standard is intended to be used in conjunction with CAN/CSA-C22.2 No. 60601-1:14, Medical electrical equipment — Part 1: General requirements for basic safety and essential performance (adopted IEC 60601-1:2005, including Amendment 1:2012, with Canadian deviations).


      This Standard has been developed in compliance with Standards Council of Canada requirements for National Standards of Canada. It has been published as a National Standard of Canada by CSA Group.


      Scope and object


      Clause 1 of the general standard2 applies, except as follows:


      201.1.1 Scope


      Replacement:


      This part of the 80601 International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of AUTOMATED SPHYGMOMANOMETERS, hereafter referred to as ME EQUIPMENT, which by means of an inflatable CUFF, are used for non-continuous indirect estimation of the BLOOD PRESSURE without arterial puncture.


      NOTE 1 Equipment that performs indirect DETERMINATION of the BLOOD PRESSURE without arterial puncture does not directly measure the BLOOD PRESSURE. It only estimates the BLOOD PRESSURE.


      This document specifies requirements for the BASIC SAFETY and ESSENTIAL PERFORMANCE for this ME EQUIPMENT and its ACCESSORIES, including the requirements for the accuracy of a DETERMINATION.


      This document covers automatic electrically-powered ME EQUIPMENT used for the intermittent, indirect estimation of the BLOOD PRESSURE without arterial puncture, including BLOOD PRESSURE monitors for the HOME HEALTHCARE ENVIRONMENT.


      Requirements for indirect estimation of the BLOOD PRESSURE without arterial puncture ME EQUIPMENT with an electrically-powered PRESSURE TRANSDUCER and/or displays used in conjunction with a stethoscope or other manual methods for determining BLOOD PRESSURE (NON-AUTOMATED SPHYGMOMANOMETERS) are specified in document ISO 81060-1 [2].


      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 201.11 and 201.105.3.3, as well as 7.2.13 and 8.4.1 of IEC 60601-1:2005.


      NOTE 2 See also 4.2 of IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012.


      201.1.2 Object


      Replacement:


      The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for an AUTOMATED SPHYGMOMANOMETER as defined in 201.3.201.


      --------------------------------------------------------------------------------------------------------------------------------


      Préface CSA


      Ce document constitue la deuxième édition de CSA C22.2 nº 80601-2-30, Appareils électromédicaux — Partie 2-30 : Exigences particulières pour la sécurité de base et les performances essentielles des sphygmomanomètres non invasifs automatiques. Il s’agit de l’adoption, avec exigences propres au Canada, de la norme IEC (Commission Électrotechnique Internationale) 80601-2-30 (deuxième édition, 2018-03), qui porte le même titre. Il remplace l'édition antérieure publiée en 2010 qui portait la désignation CAN/CSA-C22.2 nº 80601-2-30 (norme IEC 80601-2-30:2009 adoptée). Il fait partie d’une série de normes publiées par Groupe CSA qui constituent le Code canadien de l’électricité, Deuxième partie.


      Par souci de brièveté, tout au long de ce document, il sera appelé « CSA C22.2 nº 80601-2-30 ».


      Cette norme est conçue pour être utilisée de concert avec CAN/CSA-C22.2 nº 60601-1:14, Appareils électromédicaux — Partie 1 : Exigences générales pour la sécurité de base et les performances essentielles (norme IEC 60601-1:2005 adoptée, avec exigences propres au Canada, y compris l’amendement 1:2012).


      Cette norme a été élaborée conformément aux exigences du Conseil canadien des normes concernant les Normes nationales du Canada. Cette norme a été publiée en tant que Norme nationale du Canada par Groupe CSA.


      Domaine d'application et objet


      L'Article 1 de la norme générale2 s'applique avec les exceptions suivantes:


      201.1.1 Domaine d'application


      Remplacement:


      La présente partie de la Norme internationale 80601 s'applique à la SECURITE DE BASE et aux PERFORMANCES ESSENTIELLES des SPHYGMOMANOMETRES AUTOMATIQUES, ci-après dénommés APPAREILS EM, qui, au moyen d'un BRASSARD gonflable, sont utilisés pour l'estimation indirecte non continue de la PRESSION ARTERIELLE sans ponction artérielle.


      NOTE 1 Les appareils qui effectuent une DETERMINATION indirecte de la PRESSION ARTERIELLE sans ponction artérielle ne mesurent pas directement ladite PRESSION. Ils ne font qu'évaluer la PRESSION ARTERIELLE.


      Le présent document spécifie les exigences pour la SECURITE DE BASE et les PERFORMANCES ESSENTIELLES de ces APPAREILS EM et leurs ACCESSOIRES, y compris les exigences relatives à l'exactitude de la DETERMINATION de la PRESSION ARTERIELLE.


      Le présent document couvre les APPAREILS EM automatiques à énergie électrique utilisés pour l'estimation indirecte intermittente de la PRESSION ARTERIELLE sans ponction artérielle, y compris les moniteurs de PRESSION ARTERIELLE pour l'ENVIRONNEMENT DES SOINS A DOMICILE.


      Les exigences relatives aux APPAREILS EM d'estimation indirecte de la PRESSION ARTERIELLE sans ponction artérielle comportant un TRANSDUCTEUR DE PRESSION à énergie électrique et/ou des affichages utilisés conjointement avec un stéthoscope ou autres méthodes manuelles de détermination de la PRESSION ARTERIELLE (SPHYGMOMANOMETRES NON AUTOMATIQUES) sont spécifiées dans l'ISO 81060-1 [2].


      Si un article ou un paragraphe est spécifiquement destiné à être applicable uniquement aux APPAREILS EM ou uniquement aux SYSTEMES EM, le titre et le contenu de cet article ou de ce paragraphe l'indiquent. Si tel n'est pas le cas, l'article ou le paragraphe s'applique à la fois aux APPAREILS EM et aux SYSTEMES EM, selon le cas.


      Les DANGERS inhérents à la fonction physiologique prévue des APPAREILS EM ou des SYSTEMES EM dans le cadre du domaine d'application du présent document ne sont pas couverts par des exigences spécifiques contenues dans le présent document, à l'exception de 201.11 et 201.105.3.3, ainsi que 7.2.13 et 8.4.1 de l'IEC 60601-1:2005.


      NOTE 2 Voir également 4.2 de l'IEC 60601-1:2005 et de l'IEC 60601-1:2005/AMD1:2012.


      201.1.2 Objet


      Remplacement:


      L'objet de la présente norme particulière est d'établir des exigences particulières pour la SECURITE DE BASE et les PERFORMANCES ESSENTIELLES d'un SPHYGMOMANOMETRE AUTOMATIQUE tel qu'il est défini en 201.3.201.

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      CSA C22.2 NO. 80601-2-30:10 (R2019)

      Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers (Adopted IEC 80601-2-30:2009, first edition, 2009-01) | Appareils électromédicaux - Partie 2-30: Exigences particulières pour la sécurité de base et les performances essentielles des sphygmomanomètres non invasifs automatiques (norme CEI 80601-2-30:2009 adoptée, première édition, 2009-01)

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