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ANSI/AAMI ES60601-1:2005/(R)2012, (IEC 60601-1:2005, MOD)

This standard incorporates Amendment 1 with changes highlighted in the text.
AAMI Member:
$579.00
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$973.00
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A Comprehensive Overview of the Current FDA Guidances and International Standards for Medical Device Software (Webinar On Demand)

With the extensive and rapidly evolving use of software in today’s medical devices, it is important for industry professionals to understand the implications of regulatory requirements for medical device software and to be aware of the many guidances and standards that are available to industry on this important topic.
AAMI Member:
$315.00
List Price:
$415.00
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AAMI 2016 Session: Challenges in Transitioning Device Integration from One Electronic Record to Another-A Perioperative Case Study (Webinar On Demand)

Even if you couldn't make it to AAMI 2016 in Tampa, you don't have to miss all of the great education opportunities that took place.
AAMI Member:
$39.00
List Price:
$59.00
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AAMI TIR20:2001

AAMI Member:
$84.00
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$148.00
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AAMI TIR36:2007

Validation of software for regulated processes
AAMI Member:
$146.00
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$258.00
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AAMI TIR38:2014

Medical device safety assurance case guidance
AAMI Member:
$125.00
List Price:
$222.00
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AAMI TIR71:2017 (PDF)

Guidance for logging of alarm system data
AAMI Member:
$67.00
List Price:
$119.00
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AAMI/IEC TIR61289:2011

High frequency surgical equipment - Operation and maintenance.
AAMI Member:
$84.00
List Price:
$148.00
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AAMI/IEC TIR80001-2-7:2014

Application of risk management for IT-networks incorporating medical devices - Part 2-7: Application guidance - Guidance for Healthcare Delivery Organizations (HDOs) on how to self-assess their conformance with IEC 80001-1
AAMI Member:
$146.00
List Price:
$258.00
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AAMI/ISO TIR15499:2012

Biological evaluation of medical devices-Guidance on the conduct of biological evaluation within a risk management process.
AAMI Member:
$67.00
List Price:
$119.00
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AAMI/ISO TIR16775:2014

Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2
AAMI Member:
$146.00
List Price:
$258.00
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AAMI/ISO TIR19218-1:2011 & A1:2013

Medical devices hierarchal coding structure for adverse events. Part 1: Event type codes. (Includes Amendment 1)
AAMI Member:
$84.00
List Price:
$148.00
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Acute Hemodialysis: Survey Readiness Handbook

AAMI Member:
$136.00
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$233.00
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Acute Hemodialysis: Survey Readiness Handbook Set

AAMI Member:
$207.00
List Price:
$339.00
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Alarms Part I: The Joint Commission’s National Patient Safety Goal on Alarm Management: How Do We Get Started? (Webinar On Demand)

Clinical alarms are a high-frequency, high-risk patient safety hazard for all hospitals. This is the first of a series of seven webinars on alarms. By the end of the series, healthcare delivery organization alarm management teams will be prepared to comply with The Joint Commission’s (TJC) new National Patient Safety Goal (NPSG) on Alarm Management. This first webinar will set the stage for the series and outline the complexity of issues related to alarm systems and the events that have led to the spotlight on alarm systems and alarm fatigue. It will cover the overall scope of TJC's NPSG, the timeline for meeting the requirements, and how the series will help the participant start to meet the NPSG.
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$0.00
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$0.00
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ANSI/AAMI 11663:2014

Quality of dialysis fluid for hemodialysis and related therapies.
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$67.00
List Price:
$119.00
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ANSI/AAMI 13958:2014

Concentrates for hemodialysis and related therapies.
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$84.00
List Price:
$148.00
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ANSI/AAMI 13959:2014

Water for hemodialysis and related therapies.
AAMI Member:
$67.00
List Price:
$119.00
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ANSI/AAMI AT6:2013

Autologous transfusion devices.
AAMI Member:
$67.00
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$119.00
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ANSI/AAMI BF64:2012

Leukocyte reduction filters.
AAMI Member:
$67.00
List Price:
$119.00
Available for Immediate Download
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