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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:
$234.00
List Price:
$413.00
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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
Available for Immediate Download
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A Guide for Medical Device Manufacturers: Understanding and Applying the FDA Processes, Terminology, and Informational Databases for U.S. Medical Device Classification (Webinar On Demand)

This webinar provides a comprehensive overview of the FDA processes, terminology, and informational databases established for U.S. medical device classification.
AAMI Member:
$315.00
List Price:
$415.00
Available for Immediate Download
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Dialysis Standards Collection

The 2015 collection consists of 11 AAMI Hemodialysis standards, six of which were published in 2014
AAMI Member:
$357.00
List Price:
$541.00
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AAMI TIR14:2016

Contract sterilization using ethylene oxide
AAMI Member:
$67.00
List Price:
$119.00
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AAMI TIR15:2016 (PDF)

Physical aspects of ethylene oxide sterilization
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$84.00
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$148.00
Available for Immediate Download
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AAMI TIR16:2009/(R) 2013

Microbiological aspects of ethylene oxide sterilization.
AAMI Member:
$84.00
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$148.00
Available for Immediate Download
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AAMI TIR17:2008

Compatibility of Materials Subject to Sterilization
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$146.00
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$243.00
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AAMI TIR18:2010

Guidance on electromagnetic compatibility of medical devices in healthcare facilities
AAMI Member:
$125.00
List Price:
$222.00
Available for Immediate Download
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AAMI TIR19:1998 and A1:1999 (PDF Format)

AAMI Member:
$59.00
List Price:
$104.00
Available for Immediate Download
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AAMI TIR20:2001

AAMI Member:
$84.00
List Price:
$148.00
Available for Immediate Download
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AAMI TIR28:2016 (PDF)

Product adoption and process equivalence for ethylene oxide sterilization
AAMI Member:
$67.00
List Price:
$119.00
Available for Immediate Download
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AAMI TIR29:2012

Guide for process characterization and control in radiation sterilization of medical devices
AAMI Member:
$118.00
List Price:
$208.00
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AAMI TIR37:2013

Sterilization of health care products—Radiation—Guidance on sterilization of biologics and tissue-based products
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$67.00
List Price:
$119.00
Available for Immediate Download
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AAMI TIR38:2014

Medical device safety assurance case guidance
AAMI Member:
$125.00
List Price:
$222.00
Available for Immediate Download
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AAMI TIR41:2011/(R)2017

Active Implantable Medical Devices - Guidance for Designation of Left Ventricle and Implantable Cardioverter Defibrillator Lead Connectors and Pulse Generator Connector Cavities for Implantable Pacemakers and Implantable Cardioverter Defibrillators
AAMI Member:
$67.00
List Price:
$119.00
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AAMI TIR43:2011 — Ultrapure dialysate for hemodialysis and related therapies (Webinar On Demand)

ANSI/AAMI/ISO 23500:2011, Guidance for the preparation and quality management of fluids for hemodialysis and related therapies makes a recommendation that ultrapure dialysate should be used for routine hemodialysis. This is not currently the standard of practice in the U.S. The objective of AAMI TIR43:2011, Ultrapure dialysate for hemodialysis and related therapies is to provide dialysis clinics with background information to understand the rationale for the inclusion in ANSI/AAMI/ISO 23500 of this recommendation and useful strategies for implementing practices to allow provision of ultrapure dialysate.
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$79.00
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$99.00
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AAMI TIR45:2012

Guidance on the use of agile practices in the development of medical device software
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$131.00
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$222.00
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AAMI TIR45:2012, Guidance on the use of AGILE practices in the development of medical device software (Webinar On Demand)

This webinar archive provides detailed information about AAMI TIR45:2012, Guidance on the use of AGILE practices in the development of medical device software and its recommendations for complying with international standards and FDA guidance documents when using AGILE practices to develop medical device software.
AAMI Member:
$315.00
List Price:
$415.00
Available for Immediate Download
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AAMI TIR49:2013

Design of training and instructional materials for medical devices used in non-clinical environments
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$104.00
List Price:
$183.00
Available for Immediate Download
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