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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

€448.66
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

ISO 11843-1:1997 Capability of detection — Part 1: Terms and definitions
ISO 15189:2012 Medical laboratories — Requirements for quality and competence
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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