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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:
$586.00
List Price:
$999.00
Available for Immediate Download
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ANSI/AAMI/ISO 14971:2007/(R)2016

Medical devices - Application of risk management to medical devices.
AAMI Member:
$150.00
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$266.00
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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

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:
$119.00
List Price:
$199.00
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 RT2:2017 (PDF)

Radiation therapy readiness check
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$0.00
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$0.00
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AAMI ST/WG 84 Interim Meeting, July 2018

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Description: AAMI ST/WG 84, Endoscope Reprocessing, will be meeting at AAMI's office in Arlington, VA on July 19 & 20, 2018.

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

Due to space limitations, in-person attendance will be limited to Primary or Alternate members of the working group. A web/teleconference participation option will be available.
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.

Start Date:
Thursday, July 19, 2018
End Date:
Friday, July 20, 2018
Address:
AAMI Headquarters
4301 North Fairfax Drive, Suite 301
Arlington, VA 22203
UNITED STATES
AAMI Member
$0.00
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$0.00


Dialysis Standards Collection

The 2015 collection consists of 11 AAMI Hemodialysis standards, six of which were published in 2014
AAMI Member:
$368.00
List Price:
$557.00
Available for Immediate Download
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TIR19 & A1 Combined

Guidance for ANSI/AAMI/ISO 10993-7:1995, Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
AAMI Member:
$61.00
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$107.00
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AAMI TIR43:2011 — Ultrapure dialysate for hemodialysis and related therapies

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:
$15.00
List Price:
$20.00
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:
$135.00
List Price:
$229.00
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AAMI TIR45:2012, Guidance on the use of AGILE practices in the development of medical device software

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:
$119.00
List Price:
$199.00
Available for Immediate Download
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AAMI TIR58:2014

Water testing methodologies
AAMI Member:
$129.00
List Price:
$214.00
Available for Immediate Download
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AAMI TIR60:2014

Common mode rejection in ECG monitoring
AAMI Member:
$69.00
List Price:
$123.00
Available for Immediate Download
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AAMI/IEC TIR80001-2-8:2016 (PDF)

AAMI Member:
$129.00
List Price:
$229.00
Available for Immediate Download
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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:
$87.00
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$152.00
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Acute Hemodialysis: Survey Readiness Handbook

AAMI Member:
$140.00
List Price:
$240.00
Available for Immediate Download
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Acute Hemodialysis: Survey Readiness Handbook Set

AAMI Member:
$213.00
List Price:
$349.00
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AEM Program Guide

Alternative PM for Patient Safety
AAMI Member:
$60.00
List Price:
$93.00
Available for Immediate Download
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