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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.
AAMI Member:
$96.00
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$168.00
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$168.00
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ANSI/AAMI/ISO 25539-1:2017 (PDF)

Cardiovascular implants— Endovascular devices—Part 1: Endovascular prostheses
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$111.00
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$194.00
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$194.00
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ANSI/AAMI/ISO 7198:2016 (PDF)

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$133.00
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$236.00
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$236.00
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ANSI/AAMI/UL 2800-1:2019

Standard for Safety for Medical Device Interoperability
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$240.00
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$402.00
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$402.00
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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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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.
AAMI Member:
$132.00
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$220.00
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$220.00
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eSubscription - Sterilization in Healthcare: Individual User

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Description Individual subscription to Sterilization in Health Care Facilities that includes 14 sterilization standards and guidance documents, including ST79. Plus, you'll received automatic access to reaffirmations and updates.

To learn about eSubscription options for organizations, please visit Enterprise eSubscriptions.

AAMI Member:
$465.00
List Price:
$665.00
Your Price:
$665.00


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.

To learn about eSubscription options for organizations, please visit Enterprise eSubscriptions.

AAMI Member:
$635.00
List Price:
$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.

AAMI Member:
$346.00
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$396.00
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$396.00


eSubscription: Sterilization - Industrial Process Control Individual Subscription

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Description Individual Subscription to Sterilization - Industrial Process Control Collection includes 50 standards and guidance documents and is intended primarily for manufacturers who ship sterile products.

To learn about eSubscription options for organizations, please visit Enterprise eSubscriptions.

AAMI Member:
$490.00
List Price:
$660.00
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$660.00


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.
AAMI Member:
$535.00
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$749.00
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$749.00


eSubscription:Sterilization Equip Design and Use Indiv. user

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Description This sterilization collection for manufacturers and users of sterilization equipment includes 40 AAMI standards and guidance documents.

To learn about eSubscription options for organizations, please visit Enterprise eSubscriptions.

AAMI Member:
$490.00
List Price:
$660.00
Your Price:
$660.00


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
AAMI Member:
$132.00
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$220.00
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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
AAMI Member:
$96.00
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$134.00
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$134.00
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Leading Practices - Management Responsibility

Leading Practices - Management Responsibility
AAMI Member:
$40.00
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$68.00
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$68.00
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Medical Device Cybersecurity

A Guide for HTM Professionals
AAMI Member:
$155.00
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$232.00
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$232.00
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Medical Device Cybersecurity (PDF)

A Guide for HTM Professionals
AAMI Member:
$155.00
List Price:
$232.00
Your Price:
$232.00
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Personnel Safety in Sterile Processing Departments Video

This 60-minute instructional video provides information essential to the promotion of personnel safety in sterile processing departments.

Earn 1 credit hour CE through CBSPD and IAHCSMM.

The script was written by P. Richard Warburton, PhD, JD; CTO & General Counsel, ChemDAQ, Inc. It includes practical guidance on:
- Legal duties and who's who among the relevant regulatory agencies and professional organizations
- Common hazards encountered in the sterile processing department
- Bloodborne pathogens and infection prevention
- Proper selection, use, and disposal of personal protective equipment (PPE)
- Relevant standards that pertain to the use of PPE, steam and chemical sterilization, and ethylene oxide
- Safe storage, handling, and disposal of contaminated items and chemical agents
- Key elements of engineering controls that promote safe handling of sterilants and high-level disinfectants
- Appropriate labelling of chemicals
- Responsibilities of employers and staff in preventing, managing, and reporting accidents in the workplace
AAMI Member:
$132.00
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$220.00
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$220.00
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The Quality System Compendium: CGMP Requirements and Industry Practice, Third Edition

Since the 2007 publication of the second edition, there have been substantial changes in medical device technology, medical device regulatory approaches, and FDA and international guidances and standards. This new third edition has been developed to provide accurate and useful information to the medical device community, updated to reflect the current status of the many rapidly evolving areas of the medical device environment.

AAMI Member:
$390.00
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$650.00
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$650.00
This item is on backorder.
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