AAMI ISO 27186 : 2010
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
ACTIVE IMPLANTABLE MEDICAL DEVICES - FOUR-POLE CONNECTOR SYSTEM FOR IMPLANTABLE CARDIAC RHYTHM MANAGEMENT DEVICES - DIMENSIONAL AND TEST REQUIREMENTS
Hardcopy , PDF
28-07-2023
English
01-01-2010
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Glossary of equivalent standards
Committee representation
Background of ANSI/AAMI adoption of ISO 27186:2010
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.
| DocumentType |
Standard
|
| ISBN |
157020380-6
|
| Pages |
99
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Withdrawn
|
| 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 |
| 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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