Recognized Consensus Standards: Medical Devices
-
31 to 40 of 1497 Results
|
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) |
12/23/2019 | InVitro Diagnostics | 7-295 | Complete | CLSI | M52, 1st ed. August 2015 (Reaffirmed: January 2020) | Verification of Commercial Microbial Identification and Antimicrobial Susceptibility Testing Systems. |
07/15/2019 | InVitro Diagnostics | 7-289 | Partial | CLSI | MM17 2nd Edition | Verification and Validation of Multiplex Nucleic Acid Assays |
01/30/2014 | InVitro Diagnostics | 7-210 | Partial | CLSI | H26-A2 | Validation, Verification, and Quality Assurance of Automated Hematology Analyzers; Proposed Standard - Second Edition |
01/15/2013 | Software/ Informatics |
13-33 | Complete | AAMI | TIR 36:2007 | Validation of software for regulated processes |
12/18/2023 | InVitro Diagnostics | 7-320 | Partial | CLSI | H62 1st Edition | Validation of Assays Performed by Flow Cytometry |
03/16/2012 | InVitro Diagnostics | 7-225 | Complete | CLSI | GP34-A (Replaces GP34-P) | Validation and Verfication of Tubes for Venous and Capillary Blood Specimen Collection; Approved Guidance |
01/14/2019 | InVitro Diagnostics | 7-139 | Complete | CLSI | QMS24, 3rd Edition September 2016 Replaces GP27-A2 and GP29-A2 | Using Proficiency Testing to Improve the Clinical Laboratory; Approved Guideline - Second Edition |
08/14/2015 | InVitro Diagnostics | 7-253 | Complete | CLSI | EP15-A3 (Reaffirmed: September 2019) | User Verification of Precision and Estimation of Bias; Approved Guideline - Third Edition |
01/30/2014 | InVitro Diagnostics | 7-152 | Complete | CLSI | EP12-A2 | User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline - Second Edition. |
05/05/2010 | InVitro Diagnostics | 7-207 | Complete | CLSI | GP16-A3 (Replaces GP16-A2) | Urinalysis; Approved Guideline - Third Edition |
-