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U.S. Department of Health and Human Services

Recognized Consensus Standards

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1 to 13 of 13 Results
Standards Designation Number: 80601
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06/07/2018 Anesthesiology 1-138 ISO 80601-2-74 First edition 2017-05 Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment
06/07/2018 General Plastic Surgery/
General Hospital
6-403 ISO 80601-2-56 Second edition 2017-03 Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement.
06/07/2018 General Plastic Surgery/
General Hospital
6-405 IEC 80601-2-59 Edition 2.0 2017-09 Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening
08/21/2017 General Plastic Surgery/
General Hospital
6-390 IEC 80601-2-35 Edition 2.1 2016-04 CONSOLIDATED VERSION 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 [Including: Amendment 1 (2016)]
12/23/2016 Dental/
ENT
4-229 IEC 80601-2-60 Edition 1.0 2012-02 Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment
04/04/2016 Anesthesiology 1-115 ISO 80601-2-70 First Edition 2015-01-15 Medical Electrical Equipment - Part 2-70: Particular Requirements for Basic Safety and Essential Performance of Sleep Apnoea Breathing Therapy Equipment
08/14/2015 Anesthesiology 1-104 ISO 80601-2-13 First edition 2011-08-11 Medical electrical equipment -- Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation [Including: Amendment 1 (2015)]
08/14/2015 Anesthesiology 1-105 ISO 80601-2-72 First edition 2015-04-11 Medical electrical equipment -- Part 2-72: Particular requirements for basic safely and essential performance of home healthcare environment ventilators for ventilator-dependent patients
01/27/2015 Anesthesiology 1-102 ISO 80601-2-69 First edition 2014-07-15 Medical electrical equipment - Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment
07/09/2014 Cardiovascular 3-123 ANSI AAMI IEC 80601-2-30:2009 & A1:2013 Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers
IEC 80601-2-30 Edition 1.1 2013-07 Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
01/30/2014 Anesthesiology 1-96 ISO 80601-2-55 First edition 2011-12-15 Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
01/30/2014 Anesthesiology 1-98 ISO 80601-2-12 First edition 2011-04-15 Medical electrical equipment - Part 2-12: Particular requirements for the safety of lung ventilators - Critical care ventilators [Including: Technical Corrigendum 1 (2011)]
08/02/2011 Anesthesiology 1-85 ISO 80601-2-61 First edition 2011-04-01 Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
 
 
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