DS/ISO 14117:2019

Aktivt implantabelt medicinsk udstyr – Elektromagnetisk kompatibilitet – EMC-prøvningsprotokoller for implantable pacemakere, implantable konverterdefibrillatorer og kardialt resynkroniseringsudstyr

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This document specifies test methodologies for the evaluation of the electromagnetic compatibility (EMC) of active implantable cardiovascular devices that provide one or more therapies for bradycardia, tachycardia and cardiac resynchronization in conjunction with transvenous lead systems.
NOTE – This document was designed for pulse generators used with endocardial leads or epicardial leads. At the time of this edition, the authors recognized the emergence of technologies that do not use endocardial leads or epicardial leads for which adaptations of this part will be required. Such adaptations are left to the discretion of manufacturers incorporating these technologies.
It specifies performance limits of these devices, which are subject to interactions with EM emitters operating across the EM spectrum in the two following ranges:
— 0 Hz ≤ ? < 385 MHz;
— 385 MHz ≤ ? ≤ 3 000 MHz
This document also specifies requirements for the protection of these devices from EM fields encountered in a therapeutic environment and defines their required accompanying documentation, providing manufacturers of EM emitters with information about their expected level of immunity.

Antal sider: 146

Udgivet: 2019-09-11

Godkendelsesdato: 2019-09-09

Internationale relationer: ISO 14117:2019 IDT

ICS: 11.040.40 - Implantater til kirurgi, protetik og ortoptik 33.100.01 - Elektromagnetisk kompatibilitet. Generelt

Varenummer: M324555

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  • ISO/TC 150/SC 6
  • ISO/TC 150/SC 6/JWG 1

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