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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Standard Designation
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Title of Standard
 
 
08/21/2017 General II (ES/
EMC)
19-29 ANSI IEEE C63.27-2017 American National Standard for Evaluation of Wireless Coexistence
08/21/2017 General II (ES/
EMC)
19-28 IEC 62485-4 Edition 1.0 2015-01 Safety requirements for secondary batteries and battery installations - Part 4: Valve-regulated lead-acid batteries for use in portable appliances
08/21/2017 General II (ES/
EMC)
19-27 IEC 62485-3 Edition 2.0 2014-07 Safety requirements for secondary batteries and battery installations - Part 3: Traction batteries
08/21/2017 General II (ES/
EMC)
19-26 IEC 62485-2 Edition 1.0 2010-06 Safety requirements for secondary batteries and battery installations - Part 2: Stationary batteries.
08/21/2017 General II (ES/
EMC)
19-25 IEC 62485-1 Edition 1.0 2015-04 Safety requirements for secondary batteries and battery installations - Part 1: General safety information.
08/21/2017 General II (ES/
EMC)
19-24 IEC 60086-5 Edition 4.0 2016-07 Primary batteries - Part 5: Safety of batteries with aqueous electrolyte
08/21/2017 General II (ES/
EMC)
19-23 IEC 60086-4 Edition 4.0 2014-09 Primary batteries - Part 4: Safety of lithium batteries
08/21/2017 General II (ES/
EMC)
19-22 AAMI TIR69: 2017 Technical Information Report Risk management of radio-frequency wireless coexistence for medical devices and systems.
12/23/2016 General II (ES/
EMC)
19-20 ANSI IEEE C63.16-2016 (Revision of ANSI C63.16-1993) American National Standard Guide for Electrostatic Discharge Test Methodologies and Acceptance Criteria for Electronic Equipment
09/17/2018 General II (ES/
EMC)
19-19 IEC /TR 60601-4-2 Edition 1.0 2016-05 Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
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