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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
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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/IEC 80601-2-58:2014/A1:2016 (PDF)

Amendment 1 to Medical Electrical Equipment Part 2-58
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ANSI/AAMI/IEC TIR62348:2012 (PDF)

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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.
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Combined Meeting of the U.S. TAGs for IEC/TC 62 and SCs

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Combined meeting of the U.S. TAGs for IEC/TC 62 and SCs will convene at the AAMI Center of Excellence in Arlington, VA on Friday, September 20, 2019.

Please register below. Registration is necessary to ensure proper accommodations.

ALL attendees, whether in-person or by phone, will be REQUIRED to register for this meeting. Web/teleconference details will be provided to registrants after registration closes, September 14, 2019.
You must log in or create a profile in order to register.


Please note: you will receive an emailed receipt of your registration. If you don't get this receipt, please contact AAMI Standards.

Click here for a list of local hotels
*Note: AAMI staff will not be able to assist with hotel reservations. Please contact the hotel(s) directly for more information.



Date:
Friday, September 20, 2019
Time:
9:30 AM - 4:30 PM Eastern Daylight Time
Address:
901 North Glebe Road
Suite 300
Arlington, VA 22203
UNITED STATES
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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
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$885.00
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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
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$535.00
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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.
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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)
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$280.00
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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.
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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.
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$135.00
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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.
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$225.00
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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.
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$85.00
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