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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 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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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
Available for Immediate Download
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AAMI TIR34:2014

Water for the reprocessing of medical devices
AAMI Member:
$131.00
List Price:
$222.00
Available for Immediate Download
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AAMI TIR36:2007

Validation of software for regulated processes
AAMI Member:
$146.00
List Price:
$258.00
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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/ISO TIR14969:2004

Quality management systems - Medical devices - Guidance on the application of ISO 13485:2003
AAMI Member:
$125.00
List Price:
$222.00
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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:
$146.00
List Price:
$258.00
Available for Immediate Download
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Acute Hemodialysis: Survey Readiness Handbook

AAMI Member:
$136.00
List Price:
$233.00
Available for Immediate Download
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Acute Hemodialysis: Survey Readiness Handbook Set

AAMI Member:
$207.00
List Price:
$339.00
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Alarms Part VI: Current Challenges with Ventilator Alarms (Webinar On Demand)

This webinar addresses the current state of and current challenges for ventilator alarm management. The objectives of the webinar are to: identify the problems associated with ventilator alarm safety; discuss the industry perspective, including standards and alarm hierarchy; evaluate a current quality improvement process for ventilator alarm safety; identify limitations with and barriers to responding appropriately to ventilator alarms; and consider recommendations on managing alarms at the bedside.
AAMI Member:
$0.00
List Price:
$0.00
Available for Immediate Download
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ANSI/AAMI 11663:2014

Quality of dialysis fluid for hemodialysis and related therapies.
AAMI Member:
$67.00
List Price:
$119.00
Available for Immediate Download
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ANSI/AAMI RD47:2008/(R)2013

Reprocessing of hemodialyzers.
AAMI Member:
$125.00
List Price:
$222.00
Available for Immediate Download
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ANSI/AAMI ST40:2004/(R)2010

Table-top dry heat (heated air) sterilization and sterility assurance in health care facilities.
AAMI Member:
$111.00
List Price:
$185.00 - $195.00
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ANSI/AAMI ST58:2013 (PDF)

Chemical sterilization and high-level disinfection in health care facilities.
AAMI Member:
$153.00
List Price:
$258.00
Available for Immediate Download
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ANSI/AAMI ST65:2008/(R) 2013

Processing of reusable surgical textiles for use in health care facilities.
AAMI Member:
$125.00
List Price:
$222.00
Available for Immediate Download
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ANSI/AAMI SW87:2012

Application of Quality Management System concepts to Medical Device Data Systems (MDDS).
AAMI Member:
$84.00
List Price:
$148.00
Available for Immediate Download
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ANSI/AAMI/ISO 18472:2006/(R)2010

Sterilization of health care products - Biological and chemical indicators - Test equipment
AAMI Member:
$104.00 - $118.00
List Price:
$183.00 - $208.00
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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:
$118.00
List Price:
$208.00
Available for Immediate Download
↑/↓ Full Details