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U.S. Department of Health and Human Services

Recognized Consensus Standards

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07/15/2019 General Plastic Surgery/
General Hospital
6-129 ISO 594-2 Second edition 1998-09-01 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings
07/15/2019 General Plastic Surgery/
General Hospital
6-421 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)].
07/15/2019 General Plastic Surgery/
General Hospital
6-422 AAMI TIR38:2019 Medical device safety assurance case guidance
07/15/2019 General Plastic Surgery/
General Hospital
6-423 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
07/15/2019 InVitro Diagnostics 7-287 CLSI M44-S3 (2018) Zone Diameter Interpretive Standards, Corresponding Minimal Inhibitory Concentration (MIC) Interpretive Breakpoints, and Quality Control Limits for Antifungal Disk Diffusion Susceptibility Testing of Yeasts; Third Informational Supplement
07/15/2019 InVitro Diagnostics 7-288 CLSI M24 3rd Edition Susceptibility Testing of Mycobacteria, Nocardiae and other Aerobic Actinomycetes
07/15/2019 InVitro Diagnostics 7-289 CLSI MM17 2nd Edition Verification and Validation of Multiplex Nucleic Acid Assays
07/15/2019 InVitro Diagnostics 7-290 CLSI EP34 1st Edition Establishing and Verifying an Extended Measuring Interval Through Specimen Dilution and Spiking
07/15/2019 InVitro Diagnostics 7-291 CLSI EP27-A How to Construct and Interpret an Error Grid for Quantitative Diagnostic Assays, 1st Edition
07/15/2019 InVitro Diagnostics 7-292 CLSI M62 1st Edition Performance Standards for Susceptibility Testing of Mycobacteria, Nocardia spp., and other Aerobic Actinomycetes
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