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80001 TIRs - Set of 4

The set of all four TIRs to aid users in applying 80001-1, application of risk management for IT networks incorporating medical devices. This set includes 80001-2-1:2012, 80001-2-2:2012, 80001-2-3:2012, and 80001-2-4:2012.
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A Practicum for Healthcare Technology Management

Just revised, this textbook is the go to resource for new and seasoned biomedical professionals. It covers everything from The Joint Commission accreditation process and managing medical device safety to human factors engineering and evidence-based medical equipment maintenance management. Based on Les Atles' best-selling "A Practicum for Biomedical Engineering and Technology Management¬Ě" and written by experts in the profession.
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AAMI TIR11:2005/(R)2015

Selection and use of protective apparel and surgical drapes in health care facilities
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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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AAMI TIR38:2019

Medical device safety assurance case guidance
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$133.00
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AAMI TIR43:2011

Ultrapure dialysate for hemodialysis and related therapies
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$72.00
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AAMI TIR44:2012

Non-invasive blood pressure motion artifact - Testing and evaluation of NIBP device performance in the presence of motion artifact
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$90.00
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AAMI TIR58:2014

Water testing methodologies
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AAMI TIR69:2017

Risk Management of Radio-Frequency Wireless Coexistence for Medical Devices and Systems
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AAMI TIR75:2019

Factors to consider when multi-vendor devices interact via an electronic interface: Practical applications and examples
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AAMI/IEC TIR80001-2-4:2012

Application of risk management for IT-networks incorporating medical devices -- Part 2-4: General implementation guidance for healthcare delivery organizations.
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$90.00
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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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ANSI/AAMI 11663:2014

Quality of dialysis fluid for hemodialysis and related therapies.
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ANSI/AAMI 13958:2014

Concentrates for hemodialysis and related therapies.
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$90.00
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ANSI/AAMI 13959:2014

Water for hemodialysis and related therapies.
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$72.00
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ANSI/AAMI 23500:2014

Guidance for the preparation and quality management of fluids for hemodialysis and related therapies.
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ANSI/AAMI AT6:2013

Autologous transfusion devices.
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ANSI/AAMI ST79:2017

Comprehensive guide to steam sterilization and sterility assurance in health care facilities
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ANSI/AAMI/IEC 60601-1-2:2014

Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests.
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ANSI/AAMI/IEC 60601-2-16:2012 Red-Line (PDF)

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