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AAMI/IEC TIR80001-2-8:2016 (PDF)

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AAMI/IEC TIR80002-1:2009

Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software
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AAMI/ISO 13485:2016

Medical Devices—A Practical Guide, Advice from ISO/TC 210
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AAMI/ISO DTIR24971:2020 Preorder

Medical devices—Guidance on the application of ISO 14971

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AAMI/ISO/IEC Guide 63:2019

Guide to the development and inclusion of aspects of safety in International Standards for medical devices
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AAMI's Acquistion Guide for Clinical Technology Equipment

In the not-so-distant past, acquisition of clinical technology equipment largely meant acquiring stand-alone medical devices. For healthcare organizations, acquisition decisions and processes rested with a limited group of participants, and the processes they used varied widely across healthcare organizations. Acquisition of today's clinical technology equipment should be different. We have a better understanding of how systems interact within a larger, diverse ecosystem of people, practices, environments, and organizations. Acquisition strategies and processes should take all of this into account, lowering the risks attendant to these investments while helping organizations provide the best possible care. Objectives: In this webinar, we will review the end-to-end acquisition process and identify resources available to HTM and other healthcare professionals that will enhance their ability to support their organization's acquisition process in a more strategic and effective manner. Finally, we will highlight where and how HTM professionals can make the most impact in their organization's acquisition process. Audience: The webinar should be immediately applicable to HTM supervisors, managers, directors, and other management roles. Staff (individual contributors) may also find this session helpful in becoming stronger contributors to the HTM department's success. Those individuals seeking to advance into management roles will find the session useful in developing perspective and skills that will support career growth.
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AAMI's Career Planning Handbook

A Resource for Healthcare Technology Management Professionals
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AAMI's Leadership Development Guide (PDF)

A Resource for Healthcare Technology Management Professionals
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ANSI/AAMI EQ56:2013

Recommended practice for a medical equipment management program
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ANSI/AAMI EQ89:2015

Guidance for the use of medical equipment maintenance strategies and procedures
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ANSI/AAMI EQ93:2019

Medical equipment management—Vocabulary used in medical equipment programs
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ANSI/AAMI/IEC 60601-1-8:2006 & A1:2012

MEDICAL ELECTRICAL EQUIPMENT - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems.
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ANSI/AAMI/IEC 80001-1 • Successfully Launching an 80001-1-Based Program

ANSI/AAMI/IEC 80001-1:2010, Application of risk management for IT Networks incorporating medical devices - Part 1: Roles, responsibilities and activities introduces a new framework for managing safety and security when medical devices are included on a convergent, heterogeneous IT-network. This approach not only identifies the activities necessary to maintain key properties of the network (safety, effectiveness, and security), it also identifies the roles that are needed and the collaboration necessary between a healthcare delivery organization and its networked technology suppliers.
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ANSI/AAMI/IEC 80001-1:2010 (GS Kit Version)

Application of risk management for IT Networks incorporating medical devices - Part 1: Roles, responsibilities and activities, Getting Started kit version.
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ANSI/AAMI/IEC 80001-1:2010

Application of risk management for IT Networks incorporating medical devices - Part 1: Roles, responsibilities and activities.
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ANSI/AAMI/ISO 13485:2016/(R)2019

Medical devices—Quality management systems—Requirements for regulatory purposes
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ANSI/AAMI/ISO 14971:2019 (PDF)

Medical devices—Application of risk management to medical devices
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ANSI/AAMI/ISO 22442-1:2016 (PDF)

Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management.
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