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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.
$109.00
$192.00
$192.00
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ANSI/AAMI/IEC 80601-2-30:2018

Medical electrical equipment—Part 2-30: Particular requirements for basic safety and essential performance of automated type non-invasive sphygmomanometers
$137.00
$243.00
$243.00
Available for Immediate Download

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
$93.00
$162.00
$162.00
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ANSI/AAMI/IEC 80601-2-58:2014/A1:2016 (PDF)

Amendment 1 to Medical Electrical Equipment Part 2-58
$74.00
$131.00
$131.00

ANSI/AAMI/IEC TIR62348:2012 (PDF)

$192.00
$339.00
$339.00
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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.
$137.00
$243.00
$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.
$137.00
$243.00
$243.00

Applying Human Factors Engineering to Legacy Medical Devices

ANSI/AAMI/IEC 62366 calls for manufacturers to implement a rigorous HFE program in conjunction with developing medical devices for which they will seek regulatory approval; an approval that hinges on compliance with IEC standards. However, most legacy medical devices were not developed with a focus on HFE. Consequently, manufacturers are struggling to understand how much HFE is enough when reassessing the use-safety of legacy devices that they have little interest in modifying based on retrospective HFE analyses.
$135.00
$225.00
$225.00
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eSubscription: HTM Collection

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Description Individual user access. The updated collection consisting of detailed and practical resources written by and expressly for biomedical equipment technicians, clinical engineers, and other healthcare technology professionals offers guidance on topics ranging from preparing for a Joint Commission survey to troubleshooting and maintaining equipment. Includes: ANSI/AAMI EQ56:2013, ANSI/AAMI EQ89:2015, AAMI TIR18:2010, AAMI TIR21:2017, AAMI/IEC TIR62354:2015, Electrical Safety Manual, CHTM Study Guide, and related publications and articles.

To learn about eSubscription options for organizations, please visit Enterprise eSubscriptions.

AAMI Member:
$635.00
List Price:
$885.00
Your Price:
$885.00


eSubscription: Human Factors Individual User

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Description Access to Human Factors standards including ANSI/AAMI/IEC 62366, HE75, TIR49, TIR50, and TIR51.

To learn about eSubscription options for organizations, please visit Enterprise eSubscriptions.

AAMI Member:
$360.00
List Price:
$535.00
Your Price:
$535.00


Getting Started with IEC 80001 & 80001-1 Standard

Includes Getting Started with IEC 80001 handbook and ANSI/AAMI/IEC 80001-1, Application of risk management for IT Networks incorporating medical devices - Part 1: Roles, responsibilities and activities.
$168.00
$280.00
$280.00

Getting Started with IEC 80001 & 80001-1 Standard (PDF)

Includes Getting Started with IEC 80001 handbook and ANSI/AAMI/IEC 80001-1, Application of risk management for IT Networks incorporating medical devices - Part 1: Roles, responsibilities and activities. (PDF format)
$168.00
$280.00
$280.00
Available for Immediate Download

Getting Started with IEC 80001

This handbook provides essential information for healthcare providers managing medical IT-Networks. It provides practical help to those getting started with their first 80001 projects, especially in acute care contexts.
$125.00
$209.00
$209.00
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Integrating Human Factors into Design Controls: AAMI TIR59

This 90-minute webinar provides an overview of AAMI TIR59, with a focus on the practical implementation of human factors engineering/usability engineering processes, activities and their corresponding applicability to a new or pre-existing quality system's design controls in accordance with 21 CFR 820.30 as well as ANSI/AAMI/IEC 62366-1:2015.
$135.00
$225.00
$225.00
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Introduction to Updated IEC 62366 - Parts 1 & 2

In 2015, the International Electrotechnical Commission (IEC) is expected to release an updated version of IEC 62366:2007, Medical devices -- Application of usability engineering to medical devices. The updated version will have two parts. Part 1 will focus on medical device’s use-safety, describing usability engineering (aka human factors engineering) activities and end-products that will be the basis of future compliance assessments. Part 2 will have more of a tutorial nature, complementing Part 1 by describing best practices in the usability engineering of medical devices.
$135.00
$225.00
$225.00
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MP80601-2-49:2020 (IEC 80601-2-49:2020, MOD)

Medical electrical equipment—Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors
$130.00
$228.00
$228.00
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Understanding and Benefiting from AAMI/IEC 80001-1

This webinar will help suppliers of medical devices, IT technology, and telecommunications understand the standard ANSI/AAMI/IEC 80001-1:2010.
$0.00
$85.00
$85.00
Available for Immediate Download