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BS ISO 27186:2020

BS ISO 27186:2020

$215.11

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

Published By Publication Date Number of Pages
BSI 2020 90
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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.

PDF Catalog

PDF Pages PDF Title
2 undefined
7 Foreword
8 Introduction
9 1 Scope
2 Normative references
10 3 Terms and definitions
13 4 Requirements
4.1 General
4.2 Lead connector physical requirements
4.2.1 Dimensions
18 4.2.2 Materials
4.2.3 Lead connector electrical connections
4.2.4 Lead marking
20 4.2.5 Lead package labels and literature
4.3 Lead connector functional requirements
4.3.1 Functional dimensional check
21 4.3.2 Tensile loads
4.3.3 Deformation due to pin contact forces
4.3.4 Deformation due to ring contact forces
22 4.3.5 Seal zone requirement
4.3.6 Electrical isolation requirement
23 4.3.7 Dielectric strength requirement
4.3.8 Current-carrying requirement
4.3.9 Corrosion/environmental
4.4 Connector cavity physical requirements
4.4.1 Dimensions
26 4.4.2 Connector cavity electrical connections
4.4.3 Connector cavity/pulse generator marking
27 4.4.4 Pulse generator labels and literature
4.5 Connector cavity functional requirements
4.5.1 Insertion force
28 4.5.2 Retention force
29 4.5.3 Withdrawal force
4.5.4 Ring contact load
30 4.5.5 Seal zone load requirement
4.5.6 Electrical isolation requirement
4.5.7 Dielectric strength requirement
4.5.8 Current-carrying requirement (high-voltage connector cavity)
4.5.9 Contact resistance/stability
31 Annex A (normative) Electrical isolation test
36 Annex B (informative) Rational for Annex A
38 Annex C (normative) Dielectric strength test
43 Annex D (informative) Rational for Annex C
47 Annex E (normative) Current-carrying test high-voltage types
52 Annex F (informative) Rational for Annex E
54 Annex G (informative) Lead connector fatigue strength test
55 Annex H (informative) Lead connector seal zone materials
57 Annex I (informative) Seal zone creep
62 Annex J (informative) Contact resistance stability
66 Annex K (informative) Rational for Annex J
68 Annex L (informative) Selection of contact materials
70 Annex M (normative) Lead connector contact material requirements
74 Annex N (informative) Rational for Annex M
80 Annex O (informative) Rationale for requirements in this document
87 Annex P (informative) Connector products
89 Bibliography

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BS ISO 27186:2020
$215.11