20/30397032 DC - BS ISO 27186. Active implantable medical devices. Four-pole connector system for implantable cardiac rhythm management devices. Dimensional and test requirements

20/30397032 DC

BS ISO 27186. Active implantable medical devices. Four-pole connector system for implantable cardiac rhythm management devices. Dimensional and test requirements

Status : Current, Draft for public comment   Published : January 2020

Format
PDF

Format
HARDCOPY



This document specifies a four-pole connector system for implantable cardiac rhythm management 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.

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. It 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 might be safe and reliable and might have clinical advantages.




Standard Number20/30397032 DC
TitleBS ISO 27186. Active implantable medical devices. Four-pole connector system for implantable cardiac rhythm management devices. Dimensional and test requirements
StatusCurrent, Draft for public comment
Publication Date08 January 2020
Normative References(Required to achieve compliance to this standard)ASTM B348, ASTM A276, ASTM F746-04, ASTM B896, ISO 7436, ASTM F562
Informative References(Provided for Information)ASTM G5, EN 45502-2-2, ISO 14708-1, ASTM F2129, ISO 5841-3, ISO 11318, ANSI/AAMI PC69, EN 45502-2-1:2003
International RelationshipsISO/DIS 27186:2020
Draft Expiry Date03 March 2020
DescriptorsElectrical medical equipment, Heart, Prosthetic devices, Prosthesis, Implants (surgical), Medical equipment, Protected electrical equipment, Pulse generators, Electrically-operated devices
ICS11.040.40
Title in FrenchDispositifs médicaux actifs implantables — Systèmes de branchement à quatre pôles pour dispositifs implantables de gestion du rythme cardiaque — Exigences de dimensions et d'essai
CommitteeCH/150/2
PublisherBSI
FormatA4
DeliveryYes
Pages89
File Size2.663 MB
NotesWarning: this draft is not current beyond its expiry date for comments.
Price£20.00


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