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ANSI/AAMI/ISO 13408-3:2006/(R)2015

Aseptic processing of health care products - Part 3: Lyophilization.
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ANSI/AAMI/ISO 13408-4-2005/(R)2014

Aseptic processing of health care products - Part 4: Clean-in-place technologies
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ANSI/AAMI/ISO 13408-5-2006/(R)2015

Aseptic processing of health care products - Part 5: Sterilization in place
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ANSI/AAMI/ISO 13408-6:2005/(R)2013

Aseptic processing of health care products -- Part 6: Isolator systems. (Includes Amendment 1)
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ANSI/AAMI/ISO 13408-7:2012/(R)2018 (PDF)

Aseptic processing of health care products—Part 7: Alternative processes for medical devices and combination products
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ANSI/AAMI/ISO 13485:2016

Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes
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ANSI/AAMI/ISO 14160:2011/(R)2016 (PDF)

Sterilization of health care products—Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives—Requirements for characterization, development, validation and routine control of a sterilization process for medical devices
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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 14937:2009/(R) 2013

Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices.
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ANSI/AAMI/ISO 14971:2019-PDF

Medical devices—Application of risk management to medical devices
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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 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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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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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/UL 2800-1:2019

Standard for Safety for Medical Device Interoperability
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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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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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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.

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$220.00
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$360.00
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