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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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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
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)]
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
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
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