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ANSI/AAMI ST24:1999/(R)2018 (PDF)

Automatic, general purpose ethylene oxide sterilizers and ethylene oxide sterilant sources intended for use in health care facilities
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ANSI/AAMI ST41:2008/(R)2018 (PDF)

Ethylene oxide sterilization in health care facilities: Safety and effectiveness
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ANSI/AAMI ST50:2004/(R)2018 (PDF)

Dry heat (heated air) sterilizers
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ANSI/AAMI/ IEC 60601- 2-20:2009/(R)2014 & A1:2016 (PDF)

Medical Electrical Equipment—Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators
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ANSI/AAMI/ ISO 8638:2010/(R)2015

Cardiovascular implants and extracorporeal systems — Extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters
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ANSI/AAMI/IEC 60601-1-12:2016 (PDF)

Medical electrical equipment—Part 1-12: General requirements for basic safety and essential performance—Collateral standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment.
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ANSI/AAMI/IEC 60601-2-16:2012

Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment.
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ANSI/AAMI/IEC 60601-2-19:2009/(R)2014 & A1:2016 (PDF)

Medical Electrical Equipment—Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
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ANSI/AAMI/IEC 60601-2-2:2017 (PDF)

Medical electrical equipment—Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
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ANSI/AAMI/IEC 60601-2-27:2011/(R)2016

Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment.
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ANSI/AAMI/IEC 62304: 2006 & A1:2016 (Redline) (PDF)

Medical device software—Software life cycle processes
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ANSI/AAMI/IEC 62304:2006 & A1:2016 (PDF)

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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 80601-2-35:2009/A1:2016 (PDF)

Medical electrical equipment — Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use
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ANSI/AAMI/IEC 80601-2-58:2014

Medical electrical equipment - Part 2-58: Particular requirements for basic safety and essential performance of lens removal and vitrectomy devices for ophthalmic surgery
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ANSI/AAMI/ISO 10651-4:2002 (PDF)

Lung ventilators—Part 4: Particular requirements for operator-powered resuscitators
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ANSI/AAMI/ISO 10651-5:2006 (PDF)

Lung ventilators for medical use—Particular requirements for basic safety and essential performance-Part 5: Gas-powered emergency Resuscitators
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ANSI/AAMI/ISO 10993-6:2016 (PDF)

Biological evaluation of medical devices—Part 6: Tests for local effects after implantation
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ANSI/AAMI/ISO 11138-2:2017 (PDF)

Sterilization of health care products—Biological indicators—Part 2: Biological indicators for ethylene oxide sterilization processes
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ANSI/AAMI/ISO 11138-3:2017 (PDF)

Sterilization of health care products—Biological indicators—Part 3: Biological indicators for moist heat sterilization processes
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