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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 80601-2-35:2009/A1:2016 (PDF)

Medical electrical equipment — Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use
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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 10651-5:2006 (PDF)

Lung ventilators for medical use—Particular requirements for basic safety and essential performance-Part 5: Gas-powered emergency Resuscitators
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ANSI/AAMI/ISO 11137-2:2013

Sterilization of health care products -- Radiation -- Part 2: Establishing the sterilization dose.
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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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ANSI/AAMI/ISO 26782:2015 & Cor.1:2015 (Consolidated Txt) PDF

Anaesthetic and respiratory equipment — Spirometers intended for the measurement of time forced expired volumes in humans
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ANSI/AAMI/ISO 4135:2001 (PDF)


This document was approved and published when the U.S. TAG for TC 121 was held by ASTM, but it is now an AAMI standard. The original formatting has been maintained, so there are some variations from the typical AAMI style.
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ANSI/AAMI/ISO 5361:2012

Anaesthetic and Respiratory Equipment - Tracheal Tubes and Connectors
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ANSI/AAMI/ISO 5367:2015 PDF

Anaesthetic and respiratory equipment—Breathing sets and connectors
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ANSI/AAMI/ISO 80601-2-35:2009 (PDF)

ANSI/AAMI/ISO 80601-2-35:2009, Medical electrical equipment—Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use
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ANSI/AAMI/ISO 81060-2:2013

Non-invasive sphygmomanometers - Part 2: Clinical investigation of automated measurement type.
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BMET Study Guide: Preparing for Certification, 2015 Edition

Preparing for Certification and Sharpening Your Skills
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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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