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ANSI/AAMI/ISO 14161:2009/(R)2014 Redline (PDF)

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ANSI/AAMI/ISO 15882:2008/(R)2013

Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results.
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ANSI/AAMI/ISO 16142-2:2017 (PDF)

Medical devices - Recognized essential principles of safety and performance of medical devices - Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
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ANSI/AAMI/ISO 22442-1:2016 (PDF)

Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management.
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ANSI/AAMI/ISO 25539-1:2017 (PDF)

Cardiovascular implants— Endovascular devices—Part 1: Endovascular prostheses
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ANSI/AAMI/ISO 7198:2016 (PDF)

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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

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$195.00
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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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Endoscope Reprocessing Video

The Endoscope Reprocessing: Critical Training Steps to Promote Patient Safety video comes on a DVD. This 30-minute instructional video includes info on how endoscopes work, correct handling, guidance on reprocessing, and much more.
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$132.00
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$220.00
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eSubscription: HTM Collection

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Description Individual user access. The updated collection consisting of detailed and practical resources written by and expressly for biomedical equipment technicians, clinical engineers, and other healthcare technology professionals offers guidance on topics ranging from preparing for a Joint Commission survey to troubleshooting and maintaining equipment. Includes: ANSI/AAMI EQ56:2013, ANSI/AAMI EQ89:2015, AAMI TIR18:2010, AAMI TIR21:2017, AAMI/IEC TIR62354:2015, Electrical Safety Manual, CHTM Study Guide, and related publications and articles.
AAMI Member:
$635.00
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$885.00
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$885.00


eSubscription: ST79:2017 Individual

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Description Individual user access for eSubscription to the standard ANSI/AAMI ST79:2017. The eSusbcription renews on a 12 month basis.

Reorganized and Easier to Use

ST79 is THE go-to reference for steam sterilization and sterility assurance in all healthcare facilities, regardless of sterilizer or facility size. Developed by industry experts, regulators, and sterilization professionals, ST79:2017 will guide you through every step of the steam sterilization process. The updated standard includes the following:
  • A reorganization of the content to make it easier to use
  • New guidance on setting temperature and humidity parameters
  • New text on following manufacturers' instructions
  • Additional material in the annex about the types of cleaning equipment that may be used in a sterile processing department (SPD)
  • Guidance on the use of ultrasonic cleaners

Use ST79:2017, the best available guidance for steam sterilization and sterility assurance, to help you stay in compliance with accrediting bodies.

To preview this file click here.

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$396.00
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eSubscription: Sterilization in Healthcare Facilities

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Description Individual user subscription to Sterilization in Healthcare Facilities includes 14 sterilization standards and guidance documents, including TIR11, TIR12, TIR30, TIR34, TIR63, ST40, ST41, ST58, ST65, ST79 (plus a new self-assessment tool), ST90, ST91, and PB70.
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$535.00
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$749.00
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FDA Final Guidance for Infusion Pumps: Total Product Life Cycle and Safety Assurance Cases

The FDA recently released the final guidance for Infusion Pumps Total Product Life Cycle. With the final guidance, FDA lays out further details and clarification on safety assurance cases compared to the April 2010 draft guidance.
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$119.00
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Healthcare Technology Horizons, 2005 and 2007 editions

Buy both editions and save: Experts from AAMI and two nursing groups provide guidance on all of the critical issues facing medical technology professionals and nurses today, from technology integration to training to improving communication
AAMI Member:
$36.00
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$60.00
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$60.00
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Investigation of Sterilization Process Failures Video

This 35-minute instructional video provides information essential to the understanding of sterilization process failures.

Earn .5 credit hour CE through CBSPD and IAHCSMM.

The script was written by Rose Seavey, MBA, BS, CNOR, CRCST, CSPDT. It includes practical guidance on:
- Essential elements of sterility assurance
- Product sterilization identification and traceability
- Sterilization process monitoring tools
- Correct actions to take when physical monitors, chemical indicators, or biological indicators indicate a sterilization failure
- Available tools to clarify steps and guide the investigation of sterilization process failures
- Product recall process
- Ways to help prevent sterilization process failures
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$132.00
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$220.00
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ISO 13485:2016 Handbook (PDF)

Medical Devices - A Practical Guide. Advice from ISO/TC 210
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IT Horizons 2003 Edition

Experts provide guidance on meeting the challenges that information technology has brought to the medical device field. Learn about electronic data storage, real-time decision support, mergers, hackers, and more.
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$22.00
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$36.00
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$36.00
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IT Horizons 2004 Edition

In this 2004 publication, experts provide guidance on meeting the challenges of information technology in the medical device field. Learn about protecting networked devices from viruses, productivity, Citrix, training, indoor positioning systems, and much more.
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$22.00
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$36.00
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$36.00
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IT Horizons Collection

Buy all six editions (2003, 2004, 2006, 2008, 2010, & 2011) and save. Experts provide guidance and insight on integration of medical device and information technologies, networking technologies, electronic data storage, career issues, department mergers, standards and regulations, and much more.
AAMI Member:
$77.00
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$110.00
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$110.00
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Leading Practices - Management Responsibility

Leading Practices - Management Responsibility
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$40.00
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$68.00
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$68.00
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