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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 TIR34:2014/(R)2017

Water for the reprocessing of medical devices
AAMI Member:
$135.00
List Price:
$229.00
Available for Immediate Download
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AAMI TIR36:2007 (PDF)

AAMI Member:
$150.00
List Price:
$266.00
Available for Immediate Download
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AAMI TIR72:2017 (PDF Format)

Dialysis fluid chemical composition
AAMI Member:
$69.00
List Price:
$123.00
Available for Immediate Download
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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:
$150.00
List Price:
$266.00
Available for Immediate Download
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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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ANSI/AAMI 11663:2014

Quality of dialysis fluid for hemodialysis and related therapies.
AAMI Member:
$69.00
List Price:
$123.00
Available for Immediate Download
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ANSI/AAMI RD47:2008/(R)2013

Reprocessing of hemodialyzers.
AAMI Member:
$129.00
List Price:
$229.00
Available for Immediate Download
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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
AAMI Member:
$122.00
List Price:
$214.00
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ANSI/AAMI ST58:2013/(R)2018 (PDF)

Chemical sterilization and high-level disinfection in health care facilities
AAMI Member:
$150.00
List Price:
$266.00
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ANSI/AAMI ST65:2008/(R)2018 (PDF)

Processing of reusable surgical textiles for use in health care facilities
AAMI Member:
$129.00
List Price:
$229.00
Available for Immediate Download
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ANSI/AAMI/ISO 13485:2016

Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes
AAMI Member:
$129.00
List Price:
$229.00
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ANSI/AAMI/ISO 18472:2006/(R)2015 (PDF)

Sterilization of health care products — Biological and chemical indicators — Test equipment
AAMI Member:
$107.00
List Price:
$188.00
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Building for the Future: Construction and Renovation of Sterile Processing Facilities, Part II: Renovation

The second of three presentations, this program outlines several important planning elements required to manage and execute successful renovation projects in an existing sterile processing facility.
AAMI Member:
$20.00
List Price:
$35.00
Available for Immediate Download
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Design Control Guidance for Medical Device Manufacturers

FDA’s guidance on how to comply with the design control requirements of the Quality System regulation.
AAMI Member:
$23.00
List Price:
$38.00
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Design Control-Integrating The Quality System Regulation and ANSI/AAMI/ISO 13485 Requirements

images/Events/901-Glebe.jpg
Description: This intensive 3 - day course provides complete coverage of design control requirements for FDA Quality System Regulation, ANSI/AAMI/ISO 13485:2016, and the Medical Device Single Audit Program (MDSAP). With the participation of FDA representatives during the entire course, attendees have the unique opportunity to participate in a shared learning experience. An optional exam is available online for 2 weeks following the end of the program.

Start Date:
Monday, December 10, 2018
End Date:
Wednesday, December 12, 2018
Time:
8:00 AM - 5:00 PM Eastern Standard Time
Address:
AAMI Training Center
901 North Glebe Road
Arlington, VA 22203
UNITED STATES
AAMI Member
$950.00 - $2,235.00
List Price
$950.00 - $2,535.00


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
List Price:
$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:
$136.00
List Price:
$233.00
Available for Immediate Download
↑/↓ Full Details