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80001 TIRs (Set of 4 Publications - PDF Format)

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 (PDF format).
AAMI Member:
$195.00
List Price:
$413.00
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80001 TIRs (Set of 4 Publications)

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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AAMI Dialysis Standards Book/CD Combo

Includes current editions of the Dialysis book and AAMI Standards on CD-Dialysis.
AAMI Member:
$505.00
List Price:
$725.00
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AAMI Standards - Dialysis

The 2015 collection consists of 11 AAMI Hemodialysis standards, six of which were published in 2014
AAMI Member:
$357.00
List Price:
$541.00
Available for Immediate Download
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AAMI Standards on CD - Dialysis

This updated CD includes the complete collection of dialysis standards from AAMI. Searchable and easy to use, it also features valuable guidance from the FDA and CMS, along with AAMI articles.
AAMI Member:
$346.00
List Price:
$495.00
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AAMI Standards on CD - IT

This new collection is your one-stop resource for 80001 and Medical Device Data System (MDDS) guidance. Searchable and easy to use, it includes 14 standards, 5 related webinars, and other resources.

For more info on the contents of this collection, click here.

AAMI Member:
$346.00
List Price:
$495.00
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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 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 TIR28:2009/(R)2013

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 TIR37:2013

Sterilization of health care products—Radiation—Guidance on sterilization of biologics and tissue-based products
AAMI Member:
$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 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.
AAMI Member:
$79.00
List Price:
$99.00
Available for Immediate Download
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AAMI TIR45:2012

Guidance on the use of agile practices in the development of medical device software
AAMI Member:
$131.00
List Price:
$222.00
Available for Immediate Download
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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
AAMI Member:
$104.00
List Price:
$183.00
Available for Immediate Download
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AAMI TIR50:2014

Post-market surveillance of user error management
AAMI Member:
$104.00
List Price:
$183.00
Available for Immediate Download
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