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AAMI TIR21:2017 (PDF)

Systems used to forecast remaining pacemaker battery service life
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AAMI TIR41:2011/(R)2017

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
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AAMI TIR42:2010

Evaluation of particulates associated with vascular medical devices
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AAMI/ISO TIR10974:2012

Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device.
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$156.00
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$276.00
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AAMI/ISO TIR17137:2014 (PDF)

Cardiovascular implants and extracorporeal systems - Cardiovascular absorbable implants
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AAMI/ISO TIR23810:2012/(R)2015

Cardiovascular implants and artificial organs - Checklist for preoperative extracorporeal circulation equipment setup.
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$183.00
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ANSI/AAMI CI86:2017 (PDF)

Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting
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ANSI/AAMI/ ISO 14708-5: 2010/(R)2015

Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices
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ANSI/AAMI/ISO 11658:2012

Cardiovascular implants and extracorporeal systems - Blood/tissue contact surface modifications for extracorporeal perfusion systems.
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ANSI/AAMI/ISO 12417-1:2015 (PDF)

Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements
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$195.00
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ANSI/AAMI/ISO 14117:2012

Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators, and cardiac resynchronization devices.
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ANSI/AAMI/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
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ANSI/AAMI/ISO 14708-3:2017

Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators.
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ANSI/AAMI/ISO 14708-4:2008/(R)2011

Implants for surgery - Active implantable medical devices - Part 4: Implantable infusion pumps.
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ANSI/AAMI/ISO 15674:2016 (PDF)

Cardiovascular implants and artificial organs - Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags
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$59.00
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$104.00
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ANSI/AAMI/ISO 15675:2016 (PDF)

Cardiovascular implants and artificial organs - Cardiopulmonary bypass systems - Arterial blood line filters
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$104.00
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ANSI/AAMI/ISO 15676:2016 (PDF)

Cardiovascular implants and artificial organs - Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)
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ANSI/AAMI/ISO 18241:2016 (PDF)

Cardiovascular implants and extracorporeal systems - Cardiopulmonary bypass systems - Venous bubble traps
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ANSI/AAMI/ISO 18242:2016 (PDF)

Cardiovascular implants and extracorporeal systems - Centrifugal blood pumps
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ANSI/AAMI/ISO 25539-1:2017 (PDF)

Cardiovascular implants— Endovascular devices—Part 1: Endovascular prostheses
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$258.00
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