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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
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$36.00
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$36.00
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AAMI TIR34:2014/(R)2017

Water for the reprocessing of medical devices
AAMI Member:
$140.00
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$236.00
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$236.00
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AAMI TIR36:2007 (PDF)

Validation of software for regulated processes
AAMI Member:
$155.00
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$274.00
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$274.00
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AAMI TIR72:2017 (PDF)

Dialysis fluid chemical composition
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$72.00
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$127.00
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$127.00
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AAMI/ISO TIR80002-2:2017 (PDF)

Medical device software—Part 2: Validation of software for medical device quality systems
AAMI Member:
$155.00
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$274.00
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$274.00
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Acute Hemodialysis: Survey Readiness Handbook

AAMI Member:
$145.00
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$248.00
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$248.00
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Acute Hemodialysis: Survey Readiness Handbook Set

AAMI Member:
$220.00
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$360.00
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$360.00
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ANSI/AAMI 11663:2014

Quality of dialysis fluid for hemodialysis and related therapies.
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$72.00
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$127.00
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$127.00
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ANSI/AAMI RD47:2008/(R)2013

Reprocessing of hemodialyzers.
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$133.00
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$236.00
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$236.00
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ANSI/AAMI ST40:2004/(R)2018 (PDF)

Table-top dry heat (heated air) sterilization and sterility assurance in health care facilities
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$126.00
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$221.00
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$221.00
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ANSI/AAMI ST58:2013/(R)2018 (PDF)

Chemical sterilization and high-level disinfection in health care facilities
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$155.00
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$274.00
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$274.00
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ANSI/AAMI ST65:2008/(R)2018 (PDF)

Processing of reusable surgical textiles for use in health care facilities
AAMI Member:
$133.00
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$236.00
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$236.00
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ANSI/AAMI/ISO 13485:2016

Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes
AAMI Member:
$133.00
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$236.00
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$236.00
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Dialysis Water and Dialysate Recommendations: A User Guide (Book/PDF Set)

Save when you order the book and PDF together!

This book provides a side-by-side comparison of the CMS regulations and interpretive guidance for the Condition of Water and Dialysate Quality and the section related to water and dialysate from the Condition of Care at Home with the suite of ISO Standards that have been adopted as replacement for ANSI/AAMI RD52:2004.
Edited by Glenda M. Payne

AAMI Member:
$195.00
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$320.00
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$320.00
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Dialysis Water and Dialysate Recommendations: A User Guide

This book provides a side-by-side comparison of the CMS regulations and interpretive guidance for the Condition of Water and Dialysate Quality.
AAMI Member:
$141.00
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$240.00
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$240.00
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eSubscription: All Standards Individual User

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Description Individual user access to nearly 250 comprehensive national and international standards and technical documents covering sterilization, dialysis, biological evaluation of medical devices, quality systems, and medical equipment. Any updates are automatically available on the site. The site provides interactive tools that allow you to search, bookmark, comment and share.
AAMI Member:
$1,395.00
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$1,955.00
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$1,955.00


FDA's Guide to Inspections of Quality Systems

A handbook for device manufacturers to prepare for the FDA's inspection process, Quality Systems Inspections Technique (QSIT). Featuring "must know" flow charts and checklists.
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$38.00
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$62.00
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$62.00
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Hemodialysis Horizons

This special magazine frames important issues affecting the hemodialysis field and that contribute to the safety of patients around the world. Articles examine: · The current status and future directions of hemodialysis machine technology · Reimbursement issues · Home hemodialysis · Preparedness after the Gulf Coast hurricane · Sodium bicarbonate mixing considerations · Neglected safety aspects in hemodialysis machines and their related problems · Developing a QC/QA program for water purification and distribution · High quality dialysate: Its Importance to the Dialysis Patient · Computers in hemodialysis facilities
AAMI Member:
$22.00
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$36.00
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$36.00
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Industrial Sterilization: Research from the Field

This book presents 11 articles from leading experts on Industrial Ethylene Oxide Sterilization, Microbiological Methods, Steam Sterilization, and Quality Management Systems and Sterility Assurance.
AAMI Member:
$68.00
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$113.00
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$113.00
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