Recognized Consensus Standards: Medical Devices
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101 to 115 of 115 Results
Specialty Task Group Area: InVitro Diagnostics |
Results per Page |
Date of
Entry |
Specialty Task
Group Area |
Recognition
Number |
Extent of
Recognition |
Standards
Developing Organization |
Standard Designation Number and Date |
Standard Title (click for recognition information) |
06/07/2021 | InVitro Diagnostics | 7-306 | Complete | CLSI | EP06 2nd Edition | Evaluation of the Linearity of Quantitative Measurement Procedures |
06/07/2021 | InVitro Diagnostics | 7-307 | Complete | CLSI | POCT05 2nd Edition | Performance Metrics for Continuous Interstitial Glucose Monitoring |
12/20/2021 | InVitro Diagnostics | 7-309 | Complete | ISO | 17099 First edition 2014-11-15 | Radiological protection - Performance criteria for laboratories using the cytokinesis block micronucleus (CBMN) assay in peripheral blood lymphocytes for biological dosimetry |
12/20/2021 | InVitro Diagnostics | 7-310 | Complete | ISO | 19238 Second edition 2014-02-01 | Radiological protection - Performance criteria for service laboratories performing biological dosimetry by cytogenetics |
12/20/2021 | InVitro Diagnostics | 7-311 | Complete | CLSI | EP39, 1st Edition | A Hierarchical Approach to Selecting Surrogate Samples for the Evaluation of In Vitro Medical Laboratory Tests |
05/30/2022 | InVitro Diagnostics | 7-312 | Complete | CLSI | M39 5th Edition | Analysis and Presentation of Cumulative Antimicrobial Susceptibility Test Data |
12/19/2022 | InVitro Diagnostics | 7-313 | Complete | CLSI | EP27 2nd Edition | Constructing and Interpreting an Error Grid for Quantitative Measurement Procedures |
12/19/2022 | InVitro Diagnostics | 7-314 | Partial | CLSI | M27M44S, 3rd Edition | Performance Standards for Antifungal Susceptibility Testing of Yeasts |
05/29/2023 | InVitro Diagnostics | 7-315 | Complete | CLSI | EP12 3rd Edition | Evaluation of Qualitative, Binary Output Examination Performance |
05/29/2023 | InVitro Diagnostics | 7-316 | Complete | CLSI | NBS01 7th Edition | Dried Blood Spot Specimen Collection for Newborn Screening |
05/29/2023 | InVitro Diagnostics | 7-317 | Partial | CLSI | M100, 33rd Edition | Performance Standards for Antimicrobial Susceptibility Testing |
12/18/2023 | InVitro Diagnostics | 7-318 | Complete | CLSI | EP25 2nd Edition | Evaluation of Stability of In Vitro Medical Laboratory Test Reagents |
12/18/2023 | InVitro Diagnostics | 7-319 | Complete | CLSI | M23 6th Edition | Development of In Vitro Susceptibility Test Methods, Breakpoints, and Quality Control Parameters |
12/18/2023 | InVitro Diagnostics | 7-320 | Partial | CLSI | H62 1st Edition | Validation of Assays Performed by Flow Cytometry |
05/29/2024 | InVitro Diagnostics | 7-321 | Partial | CLSI | MM24 1st Edition | Molecular Methods for Genotyping and Strain Typing of Infectious Organisms |
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