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ANSI/AAMI/IEC 60601-2-19:2009/(R)2014 & A1:2016 (PDF)

Medical Electrical Equipment—Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
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ANSI/AAMI/IEC 60601-2-2:2017 (PDF)

Medical electrical equipment—Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
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ANSI/AAMI/IEC 60601-2-25:2011/(R)2016

Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs.
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ANSI/AAMI/IEC 60601-2-27:2011/(R)2016

Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment.
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ANSI/AAMI/IEC 60601-2-4:2010/A1:2018 (Consolidated Text)

Medical electrical equipment—Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators, including Amendment 1
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ANSI/AAMI/IEC 60601-2-4:2010/A1:2018 (Redline Version)

Medical electrical equipment—Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators, including Amendment 1
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ANSI/AAMI/IEC 80601-2-30:2018

Medical electrical equipment—Part 2-30: Particular requirements for basic safety and essential performance of automated type non-invasive sphygmomanometers
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ANSI/AAMI/IEC 80601-2-58:2014/A1:2016 (PDF)

Amendment 1 to Medical Electrical Equipment Part 2-58
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ANSI/AAMI/ISO 11658:2012

Cardiovascular implants and extracorporeal systems - Blood/tissue contact surface modifications for extracorporeal perfusion systems.
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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 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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BMET Study Guide: Preparing for Certification, 2019 Edition

Preparing for Certification & Sharpening Your Skills
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Building for the Future: Construction and Renovation of Sterile Processing Facilities, Part III: New Equipment Planning and Staff Development/Training

The third of three presentations, this program discusses the importance of planning and selecting the appropriate equipment mix for a healthcare sterile processing environment.
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Core Competencies for the HTM Entry-level Tech

A Guide for Curriculum Development in Academic Institutions
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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: 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.

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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 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.

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