IEC 60601-2-31-ed.3.0

Detail information

Designation: IEC 60601-2-31-ed.3.0

Publication date: 17/01/2020

Pages: 110

Country: International technical standard

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Anotation

IEC 60601-2-31:2020 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of EXTERNAL PACEMAKERS powered by an INTERNAL ELECTRICAL POWER SOURCE, hereafter referred to as ME EQUIPMENT. This document applies to PATIENT CABLES as defined in 201.3.209, but does not apply to LEADS as defined in 201.3.206. HAZARDS inherent in the intended physiological function of ME EQUIPMENT within the scope of this document are not covered by specific requirements in this document except in 7.2.13 and 8.4.1 of the general standard. This document does not apply to the implantable parts of ACTIVE IMPLANTABLE MEDICAL DEVICES covered by ISO 14708-1. This document does not apply to EXTERNAL PACEMAKERS which can be connected directly or indirectly to a SUPPLY MAINS. This document does not apply to transthoracic and oesophageal pacing ME EQUIPMENT and antitachycardia ME EQUIPMENT. IEC 60601-2-31:2020 cancels and replaces the second edition published in 2008 and Amendment 1:2011. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) The requirement for testing for energy reduction has been removed; b) The test for exposure to external defibrillation has been completely revised; c) The exclusion for testing ESD immunity only with respect to air discharges has been removed; d) Alignment with the latest edition of ISO 14708-2 for pacemakers, as well as the associated EMC standard ISO 14117; e) Additional rationale for all changes. LIEC 60601-2-31:2020 s’applique a la SECURITE DE BASE et aux PERFORMANCES ESSENTIELLES des STIMULATEURS EXTERNES alimentes par une SOURCE D’ENERGIE ELECTRIQUE INTERNE designes ci-apres sous le terme APPAREILS EM. Le present document sapplique aux CABLES PATIENT tels qu’ils sont definis en 201.3.209, mais ne s’applique pas aux DERIVATIONS telles qu’elles sont definies en 201.3.206. Les DANGERS inherents a la fonction physiologique prevue de lAPPAREIL EM dans le cadre du domaine dapplication du present document ne sont pas couverts par des exigences specifiques contenues dans le present document, a lexception de 7.2.13 et de 8.4.1 de la norme generale. Le present document ne sapplique pas aux parties implantables des DISPOSITIFS MEDICAUX IMPLANTABLES ACTIFS traites par l’ISO 14708-1. Le present document ne sapplique pas aux stimulateurs externes qui peuvent etre connectes directement ou indirectement au RESEAU D’ALIMENTATION. Le present document ne s’applique pas aux APPAREILS EM de stimulation transthoracique et osophagienne ni aux APPAREILS EM pour la tachycardie. LIEC 60601-2-31:2020 annule et remplace la deuxieme edition parue en 2008 et lAmendement 1:2011. Cette edition constitue une revision technique. Cette edition inclut les modifications techniques majeures suivantes par rapport a ledition precedente: a) L’exigence concernant l’essai de reduction d’energie a ete supprimee; b) L’essai d’exposition a la defibrillation externe a ete entierement revise; c) L’exclusion des essais dimmunite aux DES uniquement relatives aux decharges dans l’air a ete supprimee; d) Alignement sur la version la plus recente de l’ISO 14708-2 pour les stimulateurs cardiaques, ainsi que sur la norme ISO 14117 associee relative a la CEM; e) Justifications supplementaires pour toutes les modifications.