Category: AAMI

AAMI

Posted in AAMI

AAMI TIR61:2014/(R)2019

Generating reports for human factors design validation results for external cardiac defibrillators
standard by Association for the Advancement of Medical Instrumentation, 10/24/2014

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AAMI TIR 27

Sterilization of health care products – Radiation sterilization – Substantiation of 25 kGy as a sterilization dose – Method VD max
standard by Association for the Advancement of Medical Instrumentation, 10/09/2001

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AAMI ST91:2015

Flexible and semi-rigid endoscope processing in health care facilities
standard by Association for the Advancement of Medical Instrumentation, 04/10/2015

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AAMI HA60601-1-11:2015 (IEC 60601-1-11:2015, MOD)

Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment (IEC 60601-1-11:2015, MOD)
standard by Association for the Advancement of Medical Instrumentation, 08/25/2015

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AAMI ST8:2008

Hospital steam sterilizers
standard by Association for the Advancement of Medical Instrumentation, 12/04/2008

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AAMI MEM4

Medical Equipment Management Manual, 2004
Handbook / Manual / Guide by Association for the Advancement of Medical Instrumentation, 01/01/2004

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AAMI TIR102:2019

U.S. FDA 21 CFR mapping to the applicable regulatory requirement references in ISO 13485:2016 Quality Management Systems
standard by Association for the Advancement of Medical Instrumentation, 08/30/2019

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AAMI RD16-96

Hemodialyzers
standard by Association for the Advancement of Medical Instrumentation, 03/08/1996

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AAMI BF64:2012

Leukocyte reduction filters
standard by Association for the Advancement of Medical Instrumentation, 11/29/2012

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AAMI RD47:2008/(R)2013

Reprocessing of Hemodialyzers
standard by Association for the Advancement of Medical Instrumentation, 05/08/2008

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AAMI BEBK5-2

AAMI Standards and Recommended Practices – Volume 2.2 – Biomedical Equipment, Part 2: Monitoring and Diagnostic Equipment
standard by Association for the Advancement of Medical Instrumentation, 12/01/1995

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AAMI ST58-96

Safe Use and Handling of Glutaraldehyde-Based Products in Health Care Facilities
standard by Association for the Advancement of Medical Instrumentation, 08/01/1996