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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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$194.00
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ANSI/AAMI/ISO 17664:2017 (PDF)

Processing of health care products—Information to be provided by the medical device manufacturer for the processing of medical devices.

Supersedes ST81
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$111.00
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$194.00
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ANSI/AAMI/ISO 17665-1:2006/(R) 2013

Sterilization of health care products - Moist heat - Part 1 Requirements for the development, validation and routine control of a sterilization process for medical devices.
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ANSI/AAMI/ISO 20857:2010/(R)2015

Sterilization of health care products - Dry heat: Requirements for the development, validation and routine control of a sterilization process for medical devices.
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$133.00
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$236.00
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Applying Novel Sterilization Processes to Healthcare Products

This webinar will explain the process for introducing a novel sterilization process to a healthcare product and will identify the regulatory hurdles that must be met. Attendees will learn how to define, validate, and ultimately routinely control a novel sterilization process such as vaporized peracetic acid; high intensity, pulse, or UV light, microwave radiation or sound waves; or nitrogen dioxide.
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$149.00
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$249.00
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Basic Concepts in Sterilization Processes: Verification, Val

This textbook reaches beyond sterilization engineers to provide personnel working in both healthcare and medical device manufacturing with the background they need to navigate the topic of sterilization processes. Discusses the science of sterilization in plain language and describes the principles on which sterilization verification, validation, and qualification are based.
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$145.00
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$248.00
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$248.00
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Basic Concepts in Sterilization Processes: Verification, Validation, and Qualification (Set of book & PDF)

Buy both the book and PDF and save!

This textbook reaches beyond sterilization engineers to provide personnel working in both healthcare and medical device manufacturing with the background they need to navigate the topic of sterilization processes. Discusses the science of sterilization in plain language and describes the principles on which sterilization verification, validation, and qualification are based.

AAMI Member:
$220.00
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$360.00
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$360.00
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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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$68.00
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$113.00
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$113.00
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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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$68.00
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$113.00
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$113.00
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Packaging for Terminally Sterilized Medical Devices: How to Find Your Way in this Globally Regulated Industry

This two-part webinar identifies the purpose of sterile packages and packaging systems, packaging requirements sources, and shipping tests. The facilitators help attendees define the requirements of packaging standards and the types of packaging.
AAMI Member:
$149.00
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$249.00
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$249.00
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Validation of a Medical Device Cleaning Process

There is increased focus by regulators around the world on medical device cleaning processes, and many medical device manufacturers find it a considerable challenge to plan and conduct a cleaning validation. The main challenges are an establishment of the cleanliness limits and an identification of the challenge conditions to be assessed during the process validation. This webinar describes logical and risk-based approaches to overcome these challenges.
AAMI Member:
$149.00
List Price:
$249.00
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$249.00
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