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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
List Price:
$973.00
Available for Immediate Download
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AAMI News Individual, Non-US Subscribers

AAMI's official monthly newsletter keeps more than 6,000 members on top of AAMI standards activities and publications; key regulatory and legislative proposals and actions; and association programs, policies, and educational offerings. AAMI News is a benefit of AAMI membership. Non-members may subscribe.
AAMI Member:
$220.00
List Price:
$220.00
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AAMI News Individual, US Subscribers

AAMI's official monthly newsletter keeps more than 6,000 members on top of AAMI standards activities and publications; key regulatory and legislative proposals and actions; and association programs, policies, and educational offerings. AAMI News is a benefit of AAMI membership. Non-members may subscribe.
AAMI Member:
$185.00
List Price:
$185.00
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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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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
Available for Immediate Download
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AAMI 2016 Session: CMMS DataGuardians: It Takes a Team to Get Good Data (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
Available for Immediate Download
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AAMI 2016 Session: It Takes a Village: HTM, SPD and IP Working Together for Safe Patient Care (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
Available for Immediate Download
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AAMI 40th Anniversary Book

This commemorative coffee-table style book, published in recognition of AAMI’s 40th anniversary in 2007, examines the evolution of AAMI and the medical device industry over the last four decades. Using pictures and narrative from pioneers in the field, this keepsake explores the role of device regulation, the engineering community, the standards program, and quality systems initiatives.
AAMI Member:
$22.00
List Price:
$36.00
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AAMI PROC:1996/2011

AAMI Standards Program National and International (US TAG) Policies and Procedures Manuals.
AAMI Member:
$20.00
List Price:
$37.00
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AAMI PROC:1996/2011 (PDF format)

AAMI Standards Program National and International (US TAG) Policies and Procedures Manuals, PDF format.
AAMI Member:
$0.00
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$0.00
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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 TIR19:1998 and A1:1999 (PDF Format)

AAMI Member:
$59.00
List Price:
$104.00
Available for Immediate Download
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AAMI TIR32:2004/(R)2016

Medical device software risk management
AAMI Member:
$67.00
List Price:
$119.00
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
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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
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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 TIR58:2014

Water testing methodologies
AAMI Member:
$118.00
List Price:
$208.00
Available for Immediate Download
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AAMI TIR60:2014

Common mode rejection in ECG monitoring
AAMI Member:
$67.00
List Price:
$119.00
Available for Immediate Download
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AAMI/IEC TIR80001-2-8:2016 (PDF)

AAMI Member:
$125.00
List Price:
$222.00
Available for Immediate Download
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