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AAMI/ISO TIR24971:2013/(R)2016

Medical devices - Guidance on the application of ISO 14971.
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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/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 Start 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

Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes
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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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ANSI/AAMI/ISO 27185:2012/(R)2017

Cardiac rhythm management devices - Symbols to be used with cardiac rhythm management device labels, and information to be supplied - General requirements.
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ANSI/AAMI/ISO 5840-1:2015

Cardiovascular implants-Cardiac valve prostheses-Part 1: General requirements
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ANSI/AAMI/ISO 5840-2:2015

Cardiovascular implants-Cardiac valve prostheses-Part 2: Surgically implanted heart valve substitutes
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ANSI/AAMI/ISO 5840-3:2013

Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques.
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ANSI/AAMI/UL 2800-1:2019

Standard for Safety for Medical Device Interoperability
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Battery Management and Medical Devices Video

This 60-min instructional video provides information essential to the understanding of medical device batteries and the development of a battery management plan.
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Checklists for Preventing Healthcare-Associated Infections

Key Considerations for the Purchase and Use of Reusable Medical Devices
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