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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:
$249.00 - $256.00
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$438.00 - $451.00
Your Price:
$438.00 - $451.00
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AAMI HIT1000-3(PS):2019

Safety and effectiveness of health IT software and systems—Part 3: Application of risk management
AAMI Member:
$0.00
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$21.00
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$21.00
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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
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$199.00
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$199.00
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AAMI TIR57:2016/(R)2019

Principles for medical devices security—Risk management
AAMI Member:
$168.00
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$282.00
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$282.00
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AAMI TIR69:2017

Risk Management of Radio-Frequency Wireless Coexistence for Medical Devices and Systems
AAMI Member:
$137.00
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$243.00
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$243.00
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AAMI TIR97:2019

Principles for medical device security—Postmarket risk management for device manufacturers
AAMI Member:
$137.00
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$243.00
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$243.00
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AAMI/CQT Risk Management

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  • Understand risk management concepts used throughout the quality system to successful meet FDA, ANSI/AAMI/ISO 14971, and ANSI/AAMI/ISO 13485:2016 requirements
  • Learn how to use risk management to make risk-based decisions for product realization, from cradle to grave

Registration Fees:

  • AAMI Members: $2340
  • Nonmembers: $2600

Start Date:
Monday, October 12, 2020
End Date:
Wednesday, October 14, 2020
Time:
8:00 AM - 5:00 PM Eastern Daylight Time
Address:
Royal Marine Hotel
Marine Road
DUN LAOGHAIRE A96 K063
IRELAND
AAMI Member
$2,340.00
List Price
$2,600.00


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:
$133.00 - $137.00
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$236.00 - $243.00
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$236.00 - $243.00
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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.
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$137.00
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$243.00
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$243.00
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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
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$130.00
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$228.00
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$228.00
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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.
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$93.00
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$162.00
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$162.00
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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
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$114.00
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$200.00
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$200.00
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AAMI/IEC TIR80001-2-6:2014

Application of risk management for IT-networks incorporating medical—Application guidance—Part 2-6: Guidance for responsibility agreements
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$74.00
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$131.00
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$131.00
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AAMI/IEC TIR80001-2-8:2016 (PDF)

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$137.00
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$243.00
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$243.00
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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
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$129.00
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$243.00
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$243.00
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AAMI/ISO DTIR24971:2020 Preorder

Medical devices—Guidance on the application of ISO 14971

AAMI Member:
$74.00
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$131.00
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$131.00
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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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$111.00
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$194.00
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$194.00
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ANSI/AAMI ST67:2019

Sterilization of health care products—Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled “sterile”
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$74.00
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$131.00
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$131.00
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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
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$35.00
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$35.00
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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:
$476.00
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$840.00
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$840.00
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