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BS ISO 27186:2010

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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

Available format(s)

Hardcopy , PDF

Superseded date

12-01-2020

Language(s)

English

Published date

08-31-2013

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
Annex A (normative) - Electrical isolation test
Annex B (informative) - Rationale for Annex A
Annex C (normative) - Dielectric strength test
Annex D (informative) - Rationale for Annex C
Annex E (normative) - Current-carrying test high
        voltage types
Annex F (informative) - Rationale for Annex E
Annex G (informative) - Lead connector fatigue strength test
Annex H (informative) - Lead connector seal zone materials
Annex I (informative) - Seal zone creep
Annex J (informative) - Contact resistance stability
Annex K (informative) - Rationale for Annex J
Annex L (informative) - Selection of contact materials
Annex M (normative) - Lead connector contact material
        requirements
Annex N (informative) - Rationale for Annex M
Annex O (informative) - Rationale for requirements in this
        International Standard
Annex P (informative) - Connector products (e.g. adaptors,
        extenders, patient cables, etc.)
Bibliography

Describes a four-pole connector system for implantable cardiac rhythm management devices which have pacing, electrogram sensing and/or defibrillation functions.

Committee
CH/150/2
DevelopmentNote
Supersedes 08/30191626 DC. (08/2013)
DocumentType
Standard
Pages
92
PublisherName
British Standards Institution
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
ISO 27186:2010 Identical

AAMI PC69 : 2007
ASTM B 348 : 2013 : REDLINE Standard Specification for Titanium and Titanium Alloy Bars and Billets
ISO 7436:1983 Slotted set screws with cup point
EN 45502-2-2 : 2008 COR 2009 ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-2: PARTICULAR REQUIREMENTS FOR ACTIVE IMPLANTABLE MEDICAL DEVICES INTENDED TO TREAT TACHYARRHYTHMIA (INCLUDES IMPLANTABLE DEFIBRILLATORS)
ISO 14708-1:2014 Implants for surgery — Active implantable medical devices — Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
ISO 5841-3:2013 Implants for surgery — Cardiac pacemakers — Part 3: Low-profile connectors (IS-1) for implantable pacemakers
EN 45502-2-1:2003 Active implantable medical devices - Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)
ASTM F 562 : 2013 : REDLINE Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035)
ISO 11318:2002 Cardiac defibrillators — Connector assembly DF-1 for implantable defibrillators — Dimensions and test requirements
EN 45502-2-2 : 2008 COR 2009 ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-2: PARTICULAR REQUIREMENTS FOR ACTIVE IMPLANTABLE MEDICAL DEVICES INTENDED TO TREAT TACHYARRHYTHMIA (INCLUDES IMPLANTABLE DEFIBRILLATORS)

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