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
03-07-2023
Publisher
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 |
| ISO 11843-1:1997 | Capability of detection — Part 1: Terms and definitions |
| 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 |
| 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 |
| ISO 17511:2020 | In vitro diagnostic medical devices Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples |
| ISO 9000:2015 | Quality management systems — Fundamentals and vocabulary |
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