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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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ANSI/AAMI/UL 2800-1:2019

Standard for Safety for Medical Device Interoperability
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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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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
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$665.00
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$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.

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$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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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.

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$490.00
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$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.
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$535.00
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$749.00
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eSubscription:Sterilization Equip Design and Use: Individual

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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
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$660.00
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$660.00


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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Healthcare Technology Management Manual

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$155.00
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$232.00
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Healthcare Technology Management Manual

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$155.00
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$232.00
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$232.00
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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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Medical Device Cybersecurity

A Guide for HTM Professionals
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$155.00
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$232.00
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$232.00
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