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AAMI TIR12:2010

Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers
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AAMI TIR12:2010 Red-line (PDF)

Includes Designing, testing and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers and red-line format of document showing changes between the current and 2004 version in red and strikethrough, PDF format.

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$230.00
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AAMI TIR18:2010

Guidance on electromagnetic compatibility of medical devices in healthcare facilities
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AAMI TIR36:2007 (PDF)

Validation of software for regulated processes
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$150.00
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AAMI TIR49:2013

Design of training and instructional materials for medical devices used in non-clinical environments
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$188.00
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AAMI TIR65:2015

Sustainability of medical devices-Elements of a responsible product life cycle
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AAMI/ISO TIR17137:2014 (PDF)

Cardiovascular implants and extracorporeal systems - Cardiovascular absorbable implants
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AAMI/ISO TIR22442-4:2011/(R)2016

Medical devices utilizing animal tissues and their derivatives -- Part 4: Principles for elimination and/or inactivation of transmissible spongiform encephalopathy (TSE) agents and validation assays for those processes.
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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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$104.00 - $107.00
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AAMI/ISO TIR80002-2:2017 (PDF)

Medical device software—Part 2: Validation of software for medical device quality systems
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AAMI's Leadership Development Guide (PDF)

A Resource for Healthcare Technology Management Professionals
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ANSI/AAMI AT6:2013

Autologous transfusion devices.
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ANSI/AAMI BP22:1994/(R)2016

Blood Pressure Transducers
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$69.00
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$123.00
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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 HE75:2009/(R)2018 (PDF)

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ANSI/AAMI ST40:2004/(R)2018 (PDF)

Table-top dry heat (heated air) sterilization and sterility assurance in health care facilities
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ANSI/AAMI ST58:2013/(R)2018 (PDF)

Chemical sterilization and high-level disinfection in health care facilities
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ANSI/AAMI ST65:2008/(R)2018 (PDF)

Processing of reusable surgical textiles for use in health care facilities
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ANSI/AAMI/ISO 10993-13-2010/(R)2014

Biological evaluation of medical devices, Part 13: Identification and quantification of degradation products from polymeric devices.
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