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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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12/23/2019 Radiology 12-309 Complete IEC 60601-2-28 Edition 3.0 2017-06 Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
08/06/2013 Radiology 12-211 Complete IEC 60601-2-29 Edition 3.0 2008-06 Medical electrical equipment - Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators
07/06/2020 Cardiovascular 3-123 Partial IEC 80601-2-30: Edition 2.0 2018-03 Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
ANSI AAMI IEC 80601-2-30:2018 Medical electrical equipment - Part 2-30: Particular requirements for basic safety and essential performance of automated type non-invasive sphygmomanometers
06/27/2016 Radiology 12-295 Partial IEC 60601-2-33 Ed. 3.2 b:2015 Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
05/29/2023 Radiology 12-347 Complete IEC 60601-2-33 Edition 4.0 2022-08 Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
08/06/2013 Cardiovascular 3-115 Complete IEC 60601-2-34 Edition 3.0 2011-05 Medical electrical equipment - Part 2-34: Particular requirements for the basic safety, including essential performance, of invasive blood pressure monitoring 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
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
06/27/2016 Radiology 12-293 Complete IEC 60601-2-37 Edition 2.1 2015 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
12/21/2020 Cardiovascular 3-169 Partial IEC 60601-2-4 Edition 3.1 2018-02 CONSOLIDATED VERSION Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators
ANSI AAMI IEC 60601-2-4:2010/A1:2018 (Consolidated Text) Medical electrical equipment Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators, including Amendment 1
12/23/2019 Radiology 12-329 Complete IEC 60601-2-43 Edition 2.2 2019-10 CONSOLIDATED VERSION Medical electrical equipment - Part 2-43: Particular requirements for the safety and essential performance of X-ray equipment for interventional procedures
05/29/2023 Radiology 12-351 Complete IEC 60601-2-43 Edition 3.0 2022-12 Medical electrical equipment - Part 2-43: Particular requirements for the safety and essential performance of X-ray equipment for interventional procedures
06/27/2016 Radiology 12-302 Partial IEC 60601-2-44 Edition 3.2: 2016 Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of x-ray equipment for computed tomography
06/27/2016 Radiology 12-294 Complete IEC 60601-2-45 Edition 3.1 2015 Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices
07/06/2020 Cardiovascular 3-155 Complete IEC 60601-2-47 Edition 2.0 2012-02 Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performanceof ambulatory electrocardiographic systems
ANSI AAMI IEC 60601-2-47:2012/(R)2016 Medical electrical equipment -- Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems
08/06/2013 Radiology 12-205 Complete IEC 60601-2-5: Edition 3.0 2009-07 Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment
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
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)]
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
12/18/2023 Radiology 12-348 Partial IEC 60601-2-54 Edition 2.0 2022-09 Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
07/15/2019 General Plastic Surgery/
General Hospital		 6-421 Complete 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. [Including: Amendment 1 (2018)].
03/16/2012 Radiology 12-242 Complete IEC 60601-2-57 Edition 1.0 2011-01 Medical Electrical Equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
05/29/2024 Radiology 12-355 Complete IEC 60601-2-57 Edition 2.0 2023-07 Medical Electrical Equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring, cosmetic and aesthetic use
05/29/2024 Ophthalmic 10-136 Complete IEC 80601-2-58 Edition 3.0 2024-03 Medical electrical equipment - Part 2-58: Particular requirements for basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery
06/07/2021 Ophthalmic 10-126 Complete IEC 80601-2-58 Edition 2.0 2014-09 Medical electrical equipment - Part 2-58: Particular requirements for basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery [Including AMENDMENT 1 (2016)]
ANSI AAMI IEC 80601-2-58:2014 Medical electrical equipment - Part 2-58: Particular requirements for basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery [Including AMENDMENT 1 (2016)]
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
12/23/2019 Dental/
ENT		 4-262 Complete IEC 80601-2-60 Edition 2.0 2019-06 Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment
09/17/2018 Anesthesiology 1-139 Partial ISO 80601-2-61 Second edition 2017-12 (Corrected version 2018-02) Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
07/09/2014 Radiology 12-281 Complete IEC 60601-2-62 Edition 1.0 2013-07 Medical electrical equipment - Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment
06/07/2021 Radiology 12-339 Complete IEC 60601-2-63 Edition 1.2 2021-05 CONSOLIDATED VERSION Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment
09/17/2018 Radiology 12-318 Complete IEC 60601-2-64 Edition 1.0 2014-09 Medical electrical equipment - Part 2-64: Particular requirements for the basic safety and essential performance of light ion beam medical electrical equipment
06/07/2021 Radiology 12-340 Complete IEC 60601-2-65 Edition 1.2 2021-05 CONSOLIDATED VERSION Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral-X-ray equipment
09/17/2018 Radiology 12-319 Complete IEC 60601-2-68 Edition 1.0 2014-09 Medical electrical equipment - Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment
12/21/2020 Anesthesiology 1-148 Complete ISO 80601-2-69 Second edition 2020-11 Medical electrical equipment - Part 2-69: Particular requirements for the basic safety and essential performance of oxygen concentrator equipment
06/07/2021 Anesthesiology 1-151 Complete ISO 80601-2-70 Second edition 2020-11 Medical electrical equipment - Part 2-70: Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment
04/04/2016 Anesthesiology 1-115 Complete ISO 80601-2-70 First Edition 2015-01-15 Medical electrical equipment - Part 2-70: Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment
08/14/2015 Anesthesiology 1-105 Complete 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
12/18/2023 Anesthesiology 1-163 Complete ISO 80601-2-72 Second edition 2023-06 Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients
01/14/2019 Anesthesiology 1-138 Complete 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
05/29/2024 Anesthesiology 1-177 Complete ISO 80601-2-74 Second edition 2021-07 Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment
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
12/20/2021 Physical Medicine 16-232 Complete IEC 80601-2-78 Edition 1.0 2019-07 Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation
07/15/2019 Anesthesiology 1-143 Complete ISO 80601-2-79 First edition 2018-07 Medical electrical equipment - Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment
06/27/2016 Radiology 12-301 Complete IEC 60601-2-8 Edition 2.1 b:2015 Medical electrical equipment - Part 2-8: Particular requirements for the safety of therapeutic X-ray equipment operating in the range 10 kV to 1 MV
07/15/2019 Anesthesiology 1-144 Complete ISO 80601-2-80 First edition 2018-07 Medical electrical equipment - Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency
12/19/2022 Anesthesiology 1-160 Complete ISO 80601-2-84 First edition 2020-07 Medical electrical equipment - Part 2-84: Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment
05/29/2024 Neurology 17-19 Partial ISO 80601-2-85 Edition 1.0 2021-03 Medical electrical equipment - Part 2-85: Particular requirements for the basic safety and essential performance of cerebral tissue oximeter equipment
05/30/2022 Anesthesiology 1-152 Complete ISO 80601-2-87 First edition 2021-04 Medical electrical equipment - Part 2-87: Particular requirements for basic safety and essential performance of high-frequency ventilators
09/17/2018 General II (ES/
EMC)		 19-19 Partial 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
05/29/2024 General II (ES/
EMC)		 19-50 Partial IEC TS 60601-4-2 Edition 1.0 2024-03 Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
 
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