IEC 60601-2-34-ed.4.0

Detail information

Designation: IEC 60601-2-34-ed.4.0

Publication date: 25/10/2024

Pages: 0

Country: International technical standard

Where to buy?

You can buy at www.mystandards.biz

Anotation

IEC 60601-2-34:2024 applies to BASIC SAFETY and ESSENTIAL PERFORMANCE of INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT as defined in 201.3.63, hereinafter also referred to as ME EQUIPMENT. This document applies to INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT intended for use in professional healthcare facilities and in the EMERGENCY MEDICAL SERVICE ENVIRONMENT. This document does not apply to catheter tubing, catheter needles, Luer locks, taps and tap tables that connect to the DOME. This document does not apply to non-invasive blood pressure monitoring equipment. 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 follows: The clause or subclause applies to ME EQUIPMENT, as default and, only if the corresponding safety measure or function is not completely integrated into the ME EQUIPMENT but implemented as part of an ME SYSTEM, the clause or subclause applies to the ME SYSTEM. IEC 60601-2-34:2024 cancels and replaces the third edition of IEC 60601-2-34 published in 2011 and constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) revision to align with IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020, as well as new versions of collateral standards and amendments thereto; b) expansion of the scope to the emergency medical service environment; c) changed essential performance in Table 201.101; d) changed requirement for ingress protection; e) added primary operating functions; f) deleted Annex BB Alarm diagrams. LIEC 60601-2-34:2024 s’applique a la SECURITE DE BASE et aux PERFORMANCES ESSENTIELLES des APPAREILS DE SURVEILLANCE DE LA PRESSION SANGUINE PRELEVEE DIRECTEMENT definis en 201.3.63, egalement designes ci-apres APPAREILS EM. Le present document s’applique aux APPAREILS DE SURVEILLANCE DE LA PRESSION SANGUINE PRELEVEE DIRECTEMENT destines a une utilisation dans des etablissements de soins et dans l’ENVIRONNEMENT DES SERVICES MEDICAUX D’URGENCE. Le present document ne s’applique pas aux tubes et aiguilles de catheter, aux connecteurs Luer, et aux prises et panneaux de prises de connexion au DOME. Le present document ne s’applique pas non plus aux appareils de surveillance de la pression sanguine prelevee indirectement. Si un article ou un paragraphe est specifiquement destine a etre 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 cela n’est pas le cas, l’article ou le paragraphe s’applique a la fois aux APPAREILS EM et aux SYSTEMES EM, comme suit: L’article ou le paragraphe s’applique aux APPAREILS EM, par defaut et, uniquement si la fonction ou la mesure de securite correspondante n’est pas completement integree dans l’APPAREIL EM mais mise en ouvre en tant que partie d’un SYSTEME EM, l’article ou le paragraphe s’applique au SYSTEME EM. LIEC 60601-2-34:2024 annule et remplace la troisieme edition de l’IEC 60601-2-34 parue en 2011 et constitue une revision technique. Cette edition inclut les modifications techniques majeures suivantes par rapport a l’edition precedente: a) revision pour aligner sur l’IEC 60601-1:2005, l’IEC 60601-1:2005/AMD1:2012 et l’IEC 60601-1:2005/AMD2:2020, ainsi que sur les nouvelles versions des normes collaterales et de leurs amendements; b) elargissement du domaine d’application a l’environnement des services medicaux d’urgence; c) modification de la performance essentielle du Tableau 201.101; d) modification de l’exigence relative a la protection contre la penetration; e) ajout de fonctions principales de service; f) suppression de l’Annexe BB, schemas d’alarme.