ISO 27186:2020
2020-11
ISO 27186:2020
Résumé
This document specifies a four-pole connector system for implantable cardiac rhythm management (CRM) devices which have pacing, electrogram sensing and/or defibrillation functions. This document includes requirements for the connector portion of an implantable lead as well as for the mating connector cavity attached to an implantable pulse generator. Essential dimensions and performance requirements are specified together with appropriate test methods.
NOTE The safety, reliability, biocompatibility, biostability and function of any particular part are the responsibility of the manufacturer.
This document is not intended to replace or provide alternatives for unipolar or bipolar connector standards that currently exist (such as ISO 11318 and ISO 5841-3).
This document is not applicable to high-voltage systems with intended outputs greater than 1 000 V and/or 50 A. This document is not applicable to systems which include sensors or unique electrodes that are not capable of conventional pacing, electrogram sensing and/or defibrillation functions.
This document does not specify all connector features.
This document does not address all aspects of functional compatibility, safety or reliability of leads and pulse generators assembled into a system.
NOTE Lead and pulse generator connector systems not conforming to this document can be safe and reliable and can have clinical advantages.
Informations générales
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État actuel: PubliéeDate de publication: 2020-11Stade: Norme internationale à réviser [90.92]
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Edition: 2
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Comité technique :ISO/TC 150/SC 6ICS :11.040.40
- RSS mises à jour
Prochaine édition en cours d'élaboration
ISO/DIS 27186
ISO/DIS 27186
Dispositifs médicaux actifs implantables — Systèmes de branchement à quatre pôles pour dispositifs implantables de gestion du rythme cardiaque — Exigences de dimensions et d'essai
Cycle de vie
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Précédemment
AnnuléeISO 27186:2010
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Actuellement
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Sera remplacée par
ProjetISO/DIS 27186
