Source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/results.cfm?start_search=1&productcode=&category=&type=&title=&organization=&referencenumber=80601&regulationnumber=&effectivedatefrom=&effectivedateto=&PAGENUM=500
Timestamp: 2018-08-15 09:08:04
Document Index: 52794572

Matched Legal Cases: ['art 2', 'art 2', 'art 2', 'art 2', 'art 2', 'art 2', 'art 2', 'art 2']

Standards Designation Number: 80601
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.
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
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
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
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)]