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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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international electrotechnical commission
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05/29/2023 ObGyn/
Gastroenterology/
Urology		 9-149 Complete IEC 60601-2-39 Edition 3.0 2018-04 Medical electrical equipment Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment
09/09/2008 ObGyn/
Gastroenterology/
Urology		 9-7 Complete IEC 61846 First edition 1998-04 Ultrasonics - Pressure pulse lithotripters - Characteristics of fields
09/17/2018 ObGyn/
Gastroenterology/
Urology		 9-119 Complete IEC 60601-2-36 Edition 2.0 2014-04 Medical electrical equipment - Part 2-36: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy
06/07/2018 ObGyn/
Gastroenterology/
Urology		 9-114 Complete IEC 60601-2-18: Edition 3.0 2009-08 Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
06/07/2018 Neurology 17-16 Complete IEC 60601-2-10 Edition 2.1 2016-04 Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
07/15/2019 General Plastic Surgery/
General Hospital		 6-423 Complete IEC 60601-2-6 Edition 2.1 2016-04 CONSOLIDATED VERSION Medical electrical equipment - Part 2-6: Particular requirements for the basic safety and essential performance of microwave therapy equipment
06/07/2021 General Plastic Surgery/
General Hospital		 6-461 Complete IEC 60601-2-19 Edition 3.0 2020-09 Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
12/21/2020 General Plastic Surgery/
General Hospital		 6-450 Complete IEC 60601-2-50 Edition 3.0 2020-09 Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment
12/19/2022 General Plastic Surgery/
General Hospital		 6-483 Complete IEC 60601-2-35 Edition 2.0 2020-09 Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use
06/07/2021 General Plastic Surgery/
General Hospital		 6-389 Partial IEC 60601-2-2 Edition 6.0 2017-03 Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
ANSI AAMI IEC 60601-2-2:2017 Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
12/23/2019 General Plastic Surgery/
General Hospital		 6-438 Complete IEC 80601-2-77 Edition 1.0 2019-07 Medical electrical equipment - Part 2-77: Particular requirements for the BASIC SAFETY and essential performance of ROBOTICALLY ASSISTED SURGICAL EQUIPMENT
ANSI AAMI IEC 80601-2-77:2020 Medical electrical equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment
06/07/2018 General Plastic Surgery/
General Hospital		 6-405 Complete 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
05/29/2023 General Plastic Surgery/
General Hospital		 6-489 Complete IEC 60601-2-52 Edition 1.1 2015-03 CONSOLIDATED VERSION Medical electrical equipment - Part 2-52: Particular requirements for the basic safety and essential performance of medical beds
01/30/2014 General Plastic Surgery/
General Hospital		 6-321 Complete IEC 60601-2-52 Edition 1.0 2009-12 Medical electrical equipment - Part 2-52: Particular requirements for basic safety and essential performance of medical beds [Including: Technical Corrigendum 1 (2010)]
06/07/2021 General Plastic Surgery/
General Hospital		 6-462 Complete IEC 60601-2-20 Edition 3.0 2020-09 Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators
06/07/2021 General Plastic Surgery/
General Hospital		 6-463 Complete IEC 60601-2-21 Edition 3.0 2020-09 Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers
05/29/2024 General Plastic Surgery/
General Hospital		 6-500 Complete IEC 63045 Edition 1.0 2020-05 Ultrasonics - Non-focusing short pressure pulse sources including ballistic pressure pulse sources - Characteristics of fields
12/21/2020 General II (ES/
EMC)		 19-39 Complete IEC 60601-1-12 Edition 1.1 2020-07 CONSOLIDATED VERSION Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment
ANSI AAMI IEC 60601-1-12:2016 [Including AMD 1:2021] Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency [Including Amendment 1(2021)]
08/21/2017 General II (ES/
EMC)		 19-25 Complete 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)		 19-27 Complete IEC 62485-3 Edition 2.0 2014-07 Safety requirements for secondary batteries and battery installations - Part 3: Traction batteries
12/23/2019 General II (ES/
EMC)		 19-33 Complete IEC 62133-2 Edition1.0 2017-02 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems
12/23/2019 General II (ES/
EMC)		 19-32 Complete IEC 62133-1 Edition 1.0 2017-02 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 1: Nickel systems
08/21/2017 General II (ES/
EMC)		 19-24 Complete 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)		 19-26 Complete 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)		 19-28 Complete 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
 
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