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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Title of Standard
 
 
12/21/2020 Anesthesiology 1-148 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
12/21/2020 Biocompatibility 2-287 USP 43-NF38:2020 <151> Pyrogen Test (USP Rabbit Test)
12/21/2020 General I (QS/
RM)
5-131 IEC 60601-1-8 Edition 2.2 2020-07 CONSOLIDATED VERSION Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
12/21/2020 General I (QS/
RM)
5-132 IEC 60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
12/21/2020 General II (ES/
EMC)
19-36 IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
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