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ANSI/AAMI/IEC 80001-1 • Successfully Launching an 80001-1-Based Program

ANSI/AAMI/IEC 80001-1:2010, Application of risk management for IT Networks incorporating medical devices - Part 1: Roles, responsibilities and activities introduces a new framework for managing safety and security when medical devices are included on a convergent, heterogeneous IT-network. This approach not only identifies the activities necessary to maintain key properties of the network (safety, effectiveness, and security), it also identifies the roles that are needed and the collaboration necessary between a healthcare delivery organization and its networked technology suppliers.
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ANSI/AAMI/ISO 10993-15:2000/(R)2011

Biological evaluation of medical devices, Part 15: Identification and quantification of degradation products from metals and alloys.
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ANSI/AAMI/ISO 10993-9:2009/(R)2014

Biological evaluation of medical devices, Part 9: Framework for identification and quantification of potential degradation products.
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ANSI/AAMI/ISO 11138-4:2017 (PDF)

Sterilization of health care products—Biological indicators—Part 4: Biological indicators for dry heat sterilization processes
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ANSI/AAMI/ISO 14161:2009/(R)2014

Sterilization of health care products - Biological indicators - Guidance for the selection, use, and interpretation of results.
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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 5361:2012

Anaesthetic and Respiratory Equipment - Tracheal Tubes and Connectors
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AAMI/ISO TIR11139:2006

Sterilization of health care products - Vocabulary
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ANSI/AAMI/UL 2800-1:2019

Standard for Safety for Medical Device Interoperability
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Battery Management and Medical Devices Video

This 60-min instructional video provides information essential to the understanding of medical device batteries and the development of a battery management plan.
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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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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.
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eSubscription: All Standards Individual User

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Description Individual user access to nearly 250 comprehensive national and international standards and technical documents covering sterilization, dialysis, biological evaluation of medical devices, quality systems, and medical equipment. Any updates are automatically available on the site. The site provides interactive tools that allow you to search, bookmark, comment and share.
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eSubscription: All Sterilization Individual User

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Description This eSubscription provides access to all sterilization standards and technical documents for hospitals and healthcare facilities, manufacturers and users of sterilization equipment and for manufacturers who ship sterile products.
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Human Factors and Ergonomics in Health Care & Patient Safety

Human Factors and Ergonomics in Health Care and Patient Safety, 2nd Edition

The 2nd edition of this book is the ultimate compendium of human factors and ergonomics issues relevant to healthcare and patient safety. It provides a practical approach with coverage of methods, interventions, and applications. Topics include work schedules, error recovery, telemedicine, workflow analysis, simulation, health IT development and design, and patient safety management. 876 pages.
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Industrial Sterilization: Research from the Field

This book presents 11 articles from leading experts on Industrial Ethylene Oxide Sterilization, Microbiological Methods, Steam Sterilization, and Quality Management Systems and Sterility Assurance.
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Industrial Sterilization: Research from the Field (PDF)

This book presents 11 articles from leading experts on Industrial Ethylene Oxide Sterilization, Microbiological Methods, Steam Sterilization, and Quality Management Systems and Sterility Assurance. PDF format.
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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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ISO 13485:2016 Handbook (PDF)

Medical Devices - A Practical Guide. Advice from ISO/TC 210
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