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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 13408-6:2005/A1:2013

Aseptic processing of health care products -- Part 6: Isolator systems, Amendment 1.
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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 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 25539-2:2012


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ANSI/AAMI/ISO 25539-2:2012 (PDF)


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ANSI/AAMI/ISO 25539-3:2011/(R)2015

Cardiovascular implants - Endovascular devices - Part 3: Vena Cava Filters.
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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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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.

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$465.00
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$665.00
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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.

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

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eSubscription: All Sterilization Individual User

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Description Access to all sterilizaton standards and technical documents including ones such as ST58, ST79, ST91, TIR12, and TIR30. This includes automatic access to reaffirmations and updates.

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

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$820.00
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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.

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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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