Name: AAMI TIR41 : 2011
Brand: AAMI
Price: 102.68 GBP

AAMI TIR41 : 2011

Superseded

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

Available format(s)

Hardcopy , PDF

Superseded date

25-01-2020

Language(s)

English

Published date

01-01-2011

Publisher

Association for the Advancement of Medical Instrumentation

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Status	Superseded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	AAMI TIR41:2011(R2017)

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)