BS ISO 27186:2010
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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Active implantable medical devices. Four-pole connector system for implantable cardiac rhythm management devices. Dimensional and test requirements
Hardcopy , PDF
English
31-08-2013
01-12-2020
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Superseded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 | Active implantable medical devices— Electromagnetic compatibility— EMC test protocols for implantable cardiac pacemakers and implantable cardioverter defibrillators American National Standard |
| 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 |
| 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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