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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 News Individual, Non-US Subscribers

AAMI's official monthly newsletter keeps more than 6,000 members on top of AAMI standards activities and publications; key regulatory and legislative proposals and actions; and association programs, policies, and educational offerings. AAMI News is a benefit of AAMI membership. Non-members may subscribe.
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$220.00
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AAMI News Individual, US Subscribers

AAMI's official monthly newsletter keeps more than 6,000 members on top of AAMI standards activities and publications; key regulatory and legislative proposals and actions; and association programs, policies, and educational offerings. AAMI News is a benefit of AAMI membership. Non-members may subscribe.
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AAMI 40th Anniversary Book

This commemorative coffee-table style book, published in recognition of AAMI’s 40th anniversary in 2007, examines the evolution of AAMI and the medical device industry over the last four decades. Using pictures and narrative from pioneers in the field, this keepsake explores the role of device regulation, the engineering community, the standards program, and quality systems initiatives.
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AAMI CR500:2019

Basic Introduction to the IEC 60601 Series
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AAMI HIT1000-3(PS):2019

Safety and effectiveness of health IT software and systems—Part 3: Application of risk management
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AAMI RT2:2017 (PDF)

Radiation therapy readiness check
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AAMI TIR45:2012/(R)2018

Guidance on the use of AGILE practices in the development of medical device software
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AAMI TIR58:2014

Water testing methodologies
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AAMI TIR60:2014/(R)2019

Common mode rejection in ECG monitoring
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AAMI TIR77:2018 (PDF)

Sorbent-based regenerative hemodialysis systems
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AAMI/IEC TIR80001-2-8:2016 (PDF)

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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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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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