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ANSI/AAMI ES60601-1:2005/(R)2012, (IEC 60601-1:2005, MOD)

This standard incorporates Amendment 1 with changes highlighted in the text.
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AAMI HIT1000-1(PS):2018 (PDF)

Safety and effectiveness of health IT software and systems-Part 1: Fundamental concepts, principles, and requirements
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AAMI TIR102:2019

U.S. FDA 21 CFR mapping to the applicable regulatory requirement references in ISO 13485:2016 Quality Management Systems
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AAMI TIR36:2007 (PDF)

Validation of software for regulated processes
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AAMI TIR38:2019

Medical device safety assurance case guidance
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AAMI TIR60:2014/(R)2019

Common mode rejection in ECG monitoring
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AAMI/IEC TIR61289:2011

High frequency surgical equipment - Operation and maintenance.
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AAMI/IEC TIR80001-2-7:2014

Application of risk management for IT-networks incorporating medical devices - Part 2-7: Application guidance - Guidance for Healthcare Delivery Organizations (HDOs) on how to self-assess their conformance with IEC 80001-1
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AAMI/ISO TIR16775:2014

Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2
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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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ANSI/AAMI 13959:2014

Water for hemodialysis and related therapies.
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ANSI/AAMI 2700-1:2019

Medical Devices and Medical Systems—Essential safety and performance requirements for equipment comprising the patient-centric integrated clinical environment (ICE)—Part 1: General requirements and conceptual model
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ANSI/AAMI AT6:2013

Autologous transfusion devices.
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ANSI/AAMI BF64:2012

Leukocyte reduction filters.
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ANSI/AAMI BF7:2012

Blood transfusion micro-filters.
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ANSI/AAMI BP22:1994/(R)2016

Blood Pressure Transducers
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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 EC12:2000/(R)2015

Disposable ECG electrodes
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