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AAMI/IEC TIR80001-2-5:2014

Application of risk management for IT-networks incorporating medical devices - Part 2-5: Application guidance - Guidance for distributed alarm systems
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AAMI/IEC TIR80001-2-6:2014

Application of risk management for IT-networks incorporating medical—Application guidance—Part 2-6: Guidance for responsibility agreements
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AAMI/IEC TIR80001-2-6:2014 (PDF)

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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/IEC TIR80002-3:2016

Technical Information Report Medical Device Software - Part 3: Process reference model of medical device software life cycle processes (IEC 62304)
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AAMI/ISO TIR17665-2:2009/(R)2016 (PDF)

Sterilization of health care products - Moist Heat - Part 2: Guidance on the application of AAMI/ISO 17665-1
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AAMI/ISO TIR17665-3:2014/(R)2016

Sterilization of health care products - Moist Heat - Guidance on the designation of a medical product to a product family and processing category for steam sterilization
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AAMI/ISO TIR21900:2018 (PDF)

Guidance for uncertainty analysis regarding the application of ISO/TS 10974
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Acute Hemodialysis: Survey Readiness Handbook

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Acute Hemodialysis: Survey Readiness Handbook Set

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ANSI/AAMI BP22:1994/(R)2016

Blood Pressure Transducers
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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 ID54:1996/(R)2012

Enteral feeding set adapters and connectors
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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 ST91:2015

Flexible and semi-rigid endoscope processing in healthcare facilities
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ANSI/AAMI SW91:2018 (PDF)

Classification of defects in health software
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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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