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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Recognition Number: 19-38
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12/21/2020 General II (ES/
EMC)		 19-38 Partial IEC 60601-1-11 Edition 2.1 2020-07 CONSOLIDATED VERSION Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
 
 
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