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ANSI/AAMI HE75:2009/(R)2018 (PDF)

Human factors engineering—Design of medical devices
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ANSI/AAMI NS28:1988/(R)2015 (PDF)

Intracranial pressure monitoring devices
$74.00
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ANSI/AAMI ST15883-1:2009/(R)2014 &A1:2014&A2:2012 (PDF)

(Consolidated Text) (ISO 15883-1:2006, MOD) Washer-disinfectors—Part 1: General requirements, terms and definitions and tests
$160.00
$282.00
$282.00
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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 ST72:2019

Bacterial endotoxins—Test methods, routine monitoring, and alternatives to batch testing
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ANSI/AAMI ST77:2013/(R)2018 (PDF)

Containment devices for reusable medical device sterilization
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ANSI/AAMI ST91:2015: Flexible and Semi-Rigid Endoscope Processing in Health Care Facilities - What You Need to Know

With heightened public concern about cleanliness and decontamination, endoscopes and endoscope reprocessing are in the news seemingly every day. Reducing the risk of exposure to improperly reprocessed medical devices is a shared responsibility among the healthcare facilities responsible for cleaning, sterilizing, or disinfecting the devices.
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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 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 60601-2-20:2009/(R)2014 & A1:2016 (PDF)

Medical Electrical Equipment—Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators
$130.00
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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 62366-1:2015 (PDF)

Medical Devices Part 1: Application of Usability Engineering to Medical Devices
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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

Application of risk management for IT Networks incorporating medical devices - Part 1: Roles, responsibilities and activities.
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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 10993-1:2018

Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process
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