BS ISO 27186:2020
Current
The latest, up-to-date edition.
Active implantable medical devices. Four-pole connector system for implantable cardiac rhythm management devices. Dimensional and test requirements
Hardcopy , PDF
English
01-12-2020
Important note : All end users must be registered with an Account prior to user licenses being assigned.| Committee |
CH/150/2
|
| DocumentType |
Standard
|
| Pages |
90
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
| Supersedes |
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 ISO11318 and ISO5841-3).This document is not applicable to high-voltage systems with intended outputs greater than 1000V and/or 50A. 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.
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.