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Superseded
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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Superseded date
13-11-2025
Superseded by
€347.38
Excluding VAT
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Superseded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 |
| CLSI EP37:2018 | Supplemental Tables for Interference Testing in Clinical Chemistry |
| CLSI MM17:2018 | Validation and Verification of Multiplex Nucleic Acid Assays, 2nd Edition |
| CLSI EP07 3ED : 2018 | Interference Testing in Clinical Chemistry, 3rd Edition |
| ISO 105-E04:2013 | Textiles — Tests for colour fastness — Part E04: Colour fastness to perspiration |
| CLSI C37 A : 1ED 99 | PREPARATION AND VALIDATION OF COMMUTABLE FROZEN HUMAN SERUM POOLS AS SECONDARY REFERENCE MATERIALS FOR CHOLESTEROL MEASUREMENT PROCEDURES |
| 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 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 |
| 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 |
| CLSI EP14 A3 : 2014 | EVALUATION OF COMMUTABILITY OF PROCESSED SAMPLES |
| 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 |
| CLSI EP34:2018 | Establishing and Verifying an Extended Measuring Interval Through Specimen Dilution and Spiking, 1st Edition |
| CLSI EP25 A : 1ED 2009 | EVALUATION OF STABILITY OF IN VITRO DIAGNOSTIC REAGENTS |
| ISO/TR 24971:2020 | Medical devices — Guidance on the application of ISO 14971 |
| CLSI EP19 : 2020 | Help Validate and Verify Laboratory Developed Tests: Using EP19, A Framework for Using CLSI Documents |
| CLSI M29 A4 : 4ED 2014 | Protection of Laboratory Workers From Occupationally Acquired Infections<br> |
| CLSI C49 ED2E : 2018 | Analysis of Body Fluids in Clinical Chemistry, 2nd Edition<br> |
| CLSI EP30 A : 1ED 2010 | CHARACTERIZATION AND QUALIFICATION OF COMMUTABLE REFERENCE MATERIALS FOR LABORATORY MEDICINE |
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