AAMI TIR41 : 2011
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
ACTIVE IMPLANTABLE MEDICAL DEVICES - GUIDANCE FOR DESIGNATION OF LEFT VENTRICLE AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LEAD CONNECTORS AND PULSE GENERATOR CONNECTOR CAVITIES FOR IMPLANTABLE PACEMAKERS AND IMPLANTABLE CARDIOVERTER DEFIBRILLATORS
English
01-01-2011
25-01-2020
Glossary of equivalent standards
Committee representation
Foreword
1 Scope
2 Normative references
3 Definitions
4 High-voltage lead connector shock
electrode labels
5 Color labeling of DF-1 lead connectors
6 Color labeling and nomenclature of IS-1
connectors for biventricular devices
(for CRT)
7 Color labeling of DF4 lead connectors
8 Color label for IS4 lead connectors
9 Lead length labeling Annexes
Annexes
A - Rationale
B - Marking examples
Specifies guidance for the color coding and marking of IS-1, DF-1, IS4, and DF4 connectors to reduce the potential for lead-to-pulse generator connection errors during implant surgery.
| DocumentType |
Standard
|
| Pages |
17
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Superseded
|
| SupersededBy |
| ISO 14708-2:2012 | Implants for surgery — Active implantable medical devices — Part 2: Cardiac pacemakers |
| 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 |
| ISO 27186:2010 | Active implantable medical devices — Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements |
| ISO 10993-1:2009 | Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process |
| ISO 11318:2002 | Cardiac defibrillators — Connector assembly DF-1 for implantable defibrillators — Dimensions and test requirements |
| ISO 14708-6:2010 | Implants for surgery — Active implantable medical devices — Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators) |
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