Recognized Consensus Standards: Medical Devices
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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) |
05/29/2023 | InVitro Diagnostics | 7-317 | Partial | CLSI | M100, 33rd Edition | Performance Standards for Antimicrobial Susceptibility Testing |
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 | 7-315 | Complete | CLSI | EP12 3rd Edition | Evaluation of Qualitative, Binary Output Examination Performance |
12/19/2022 | InVitro Diagnostics | 7-313 | Complete | CLSI | EP27 2nd Edition | Constructing and Interpreting an Error Grid for Quantitative Measurement Procedures |
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 |
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 | 7-309 | 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 |
06/07/2021 | InVitro Diagnostics | 7-306 | Complete | CLSI | EP06 2nd Edition | Evaluation of the Linearity of Quantitative Measurement Procedures |
12/21/2020 | InVitro Diagnostics | 7-304 | Complete | CLSI | M23 5th Edition | Development of In Vitro Susceptibility Testing Criteria and Quality Control Parameters |
12/21/2020 | InVitro Diagnostics | 7-299 | Complete | CLSI | POCT14 2nd Edition | Point-of-Care Coagulation Testing and Anticoagulation Monitoring |