CLSI EP12:2023
Current
Current
The latest, up-to-date edition.
Evaluation of Qualitative, Binary Output Examination Performance
Available format(s)
Hardcopy , PDF
Language(s)
English
Published date
07-03-2023
Publisher
€347.38
Excluding VAT
This guideline includes descriptions of the types of qualitative, binary output examinations and procedures for evaluating their performance.
| DocumentType |
Standard
|
| ISBN |
978-1-68440-176-5
|
| Pages |
140
|
| PublisherName |
Clinical Laboratory Standards Institute
|
| Status |
Current
|
| Supersedes |
| CLSI H20:2026 | Reference Leukocyte Differential Count (Proportional) and Evaluation of Instrumental Methods |
| CLSI EP37:2018 | Supplemental Tables for Interference Testing in Clinical Chemistry |
| CLSI MM17:2018 | Validation and Verification of Multiplex Nucleic Acid Assays, 2nd Edition |
| ISO 11843-1:1997 | Capability of detection — Part 1: Terms and definitions |
| CLSI EP07 3ED : 2018 | Interference Testing in Clinical Chemistry, 3rd Edition |
| ISO 15189:2012 | Medical laboratories — Requirements for quality and competence |
| CLSI EP35 : 2019 | Assessment of Equivalence or Suitability of Specimen Types for Medical Laboratory Measurement Procedures, 1st Edition |
| CLSI EP05-A3:2014(R2019) | Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline—Third Edition |
| ISO 18153:2003 | In vitro diagnostic medical devices — Measurement of quantities in biological samples — Metrological traceability of values for catalytic concentration of enzymes assigned calibrators and control materials |
| CLSI MM22 A : 1ED 2014 | MICROARRAYS FOR DIAGNOSIS AND MONITORING OF INFECTIOUS DISEASES |
| ISO 17511:2020 | In vitro diagnostic medical devices — Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples |
| CLSI EP19:2022 | A Framework for Using CLSI Documents to Evaluate Medical Laboratory Test Methods |
| ISO 9000:2015 | Quality management systems — Fundamentals and vocabulary |
| CLSI EP15 A3 : 2014(R2019) | User Verification of Precision and Estimation of Bias; Approved Guideline—Third Edition |
| CLSI EP26 ED2:2022 | User Evaluation of Acceptability of a Reagent Lot Change |
| CLSI EP25 A : 1ED 2009 | EVALUATION OF STABILITY OF IN VITRO DIAGNOSTIC REAGENTS |
| CLSI EP39 ED1:2021 | A Hierarchical Approach to Selecting Surrogate Samples for the Evaluation of In Vitro Medical Laboratory Tests |
| CLSI M29 A4 : 4ED 2014 | Protection of Laboratory Workers From Occupationally Acquired Infections<br> |
Summarise
€347.38
Excluding VAT
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