CLSI EP39 ED1:2021
Superseded
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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A Hierarchical Approach to Selecting Surrogate Samples for the Evaluation of In Vitro Medical Laboratory Tests
Available format(s)
Hardcopy , PDF
Language(s)
English
Published date
11-11-2021
Publisher
Superseded date
11-13-2025
Superseded by
US$304.00
Excluding Tax where applicable
This guideline establishes a definition of “surrogate sample” and an approach for selecting, preparing, and using these samples.
| DocumentType |
Standard
|
| ISBN |
978-1-68440-130-7
|
| Pages |
144
|
| ProductNote |
THIS STANDARD IS REFERS TO : ISO 14971:2019,CLSI EP05-A3:2014
|
| PublisherName |
Clinical Laboratory Standards Institute
|
| Status |
Superseded
|
| SupersededBy |
| CLSI EP12:2023 | Evaluation of Qualitative, Binary Output Examination Performance |
| CLSI EP47:2024 | Evaluation of Reagent Carryover Effects on Test Results |
| ISO 15194:2009 | In vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Requirements for certified reference materials and the content of supporting documentation |
| ISO 105-E04:2013 | Textiles — Tests for colour fastness — Part E04: Colour fastness to perspiration |
| ISO 15193:2009 | In vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Requirements for content and presentation of reference measurement procedures |
| ISO 18113-1:2009 | In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements |
| ISO 15189:2012 | Medical laboratories — Requirements for quality and competence |
| ISO 10993-12:2021 | Biological evaluation of medical devices — Part 12: Sample preparation and reference materials |
| CLSI EP06 ED2:2020 | Evaluation of Linearity of Quantitative Measurement Procedures, 2nd Edition |
| ISO 23640:2011 | In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents |
| 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 22367:2020 | Medical laboratories — Application of risk management to medical laboratories |
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