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ANSI/AAMI/ISO 14971:2007/(R)2016

Medical devices - Application of risk management to medical devices.
AAMI Member:
$150.00
List Price:
$266.00
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80001 TIRs - Set of 4

The set of all four TIRs to aid users in applying 80001-1, application of risk management for IT networks incorporating medical devices. This set includes 80001-2-1:2012, 80001-2-2:2012, 80001-2-3:2012, and 80001-2-4:2012.
AAMI Member:
$201.00 - $241.00
List Price:
$425.00
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AAMI TIR57: Principles for Medical Device Security--Risk Management Webinar

This webinar, led by the co-chairs of the committee who developed TIR57, outlines the document and its application to your business. TIR57 provides guidance for addressing information security within the risk management framework defined by ANSI/AAMI/ISO 14971.
AAMI Member:
$119.00
List Price:
$199.00
Available for Immediate Download
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AAMI TIR57:2016

Principles for Medical Device Security - Risk Management
AAMI Member:
$158.00
List Price:
$266.00
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AAMI TIR69:2017

Risk Management of Radio-Frequency Wireless Coexistence for Medical Devices and Systems
AAMI Member:
$129.00
List Price:
$229.00
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AAMI/IEC TIR80001-2-1:2012

Application of risk management for IT-networks incorporating medical devices - Part 2-1: Step by step risk management of medical IT-networks; Practical applications and examples.
AAMI Member:
$129.00
List Price:
$229.00
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AAMI/IEC TIR80001-2-2:2012

Application of risk management for IT-networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls.
AAMI Member:
$129.00
List Price:
$229.00
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AAMI/IEC TIR80001-2-3:2012

Application of risk management for IT-networks incorporating medical devices - Part 2-3: Guidance for wireless networks
AAMI Member:
$122.00
List Price:
$214.00
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AAMI/IEC TIR80001-2-4:2012

Application of risk management for IT-networks incorporating medical devices -- Part 2-4: General implementation guidance for healthcare delivery organizations.
AAMI Member:
$87.00
List Price:
$152.00
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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
AAMI Member:
$107.00
List Price:
$188.00
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AAMI/IEC TIR80001-2-8:2016 (PDF)

AAMI Member:
$129.00
List Price:
$229.00
Available for Immediate Download
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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
AAMI Member:
$121.00
List Price:
$229.00
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AAMI/ISO TIR15499:2017 (PDF)

Biological evaluation of medical devices - Guidance on the conduct of biological evaluation within a risk management process
AAMI Member:
$87.00
List Price:
$152.00
Available for Immediate Download
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AAMI/ISO TIR24971:2013/(R)2016

Medical devices - Guidance on the application of ISO 14971.
AAMI Member:
$69.00
List Price:
$123.00
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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.
AAMI Member:
$20.00
List Price:
$35.00
Available for Immediate Download
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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.
AAMI Member:
$448.00
List Price:
$792.00
Available for Immediate Download
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ANSI/AAMI/IEC 62366-1:2015 (PDF)

Medical Devices Part 1: Application of Usability Engineering to Medical Devices
AAMI Member:
$122.00
List Price:
$214.00
Available for Immediate Download
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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.
AAMI Member:
$0.00
List Price:
$85.00
Available for Immediate Download
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ANSI/AAMI/IEC 80001-1:2010 (GS Kit Version)

Application of risk management for IT Networks incorporating medical devices - Part 1: Roles, responsibilities and activities, Getting Start kit version.
AAMI Member:
$41.00
List Price:
$88.00
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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.
AAMI Member:
$102.00
List Price:
$180.00
Available for Immediate Download
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