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AAMI TIR41:2011/(R)2020

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
$74.00
$131.00
$131.00
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AAMI TIR21:2017/(R)2020

Systems used to forecast remaining pacemaker battery service life
$137.00
$243.00
$243.00
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AAMI TIR42:2010

Evaluation of particulates associated with vascular medical devices
$130.00
$228.00
$228.00
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AAMI/ISO TIR10974:2018 (PDF)

Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device.
$171.00
$302.00
$302.00
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AAMI/ISO TIR17137:2014 (PDF)

Cardiovascular implants and extracorporeal systems - Cardiovascular absorbable implants
$93.00
$162.00
$162.00
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AAMI/ISO TIR21900:2018 (PDF)

Guidance for uncertainty analysis regarding the application of ISO/TS 10974
$74.00
$131.00
$131.00
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AAMI/ISO TIR23810:2012/(R)2015

Cardiovascular implants and artificial organs - Checklist for preoperative extracorporeal circulation equipment setup.
$114.00
$200.00
$200.00

ANSI/AAMI CI86:2017 (PDF)

Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting
$160.00
$282.00
$282.00
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ANSI/AAMI/ISO 11658:2012

Cardiovascular implants and extracorporeal systems - Blood/tissue contact surface modifications for extracorporeal perfusion systems.
$65.00
$114.00
$114.00
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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
$125.00
$207.00
$207.00
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ANSI/AAMI/ISO 14117:2019

Active implantable medical devices—Electromagnetic compatibility—EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
$160.00
$282.00
$282.00
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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
$137.00
$243.00
$243.00
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ANSI/AAMI/ISO 14708-3:2017 (PDF)

$130.00
$228.00
$228.00
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ANSI/AAMI/ISO 14708-4:2008/(R)2011

Implants for surgery - Active implantable medical devices - Part 4: Implantable infusion pumps.
$130.00
$228.00
$228.00
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ANSI/AAMI/ISO 14708-5: 2010/(R)2015

Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices
$133.00
$222.00
$222.00

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
$65.00
$114.00
$114.00
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ANSI/AAMI/ISO 15675:2016 (PDF)

Cardiovascular implants and artificial organs - Cardiopulmonary bypass systems - Arterial blood line filters
$65.00
$114.00
$114.00
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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)
$74.00
$131.00
$131.00
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ANSI/AAMI/ISO 18241:2016 (PDF)

Cardiovascular implants and extracorporeal systems - Cardiopulmonary bypass systems - Venous bubble traps
$93.00
$162.00
$162.00
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ANSI/AAMI/ISO 18242:2016 (PDF)

Cardiovascular implants and extracorporeal systems - Centrifugal blood pumps
$74.00
$131.00
$131.00
Available for Immediate Download