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  • ISO 20391-1:2018

    Current The latest, up-to-date edition.

    Biotechnology — Cell counting — Part 1: General guidance on cell counting methods

    Available format(s):  Hardcopy, PDF, PDF 3 Users, PDF 5 Users, PDF 9 Users

    Language(s):  English

    Published date:  19-01-2018

    Publisher:  International Organization for Standardization

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    ISO 20391-1:2018 defines terms related to cell counting for biotechnology. It describes counting of cells in suspension (generally cell concentration) and cells adhered to a substrate (generally area density of cells). It provides key considerations for general counting methods (including total and differential counting, and direct and indirect counting) as well as for method selection, measurement process, and data analysis and reporting.

    ISO 20391-1:2018 is applicable to the counting of all cell types ? mammalian and non-mammalian (e.g. bacteria, yeast) cells.

    ISO 20391-1:2018 is not intended for counting of cells while in a tissue section or a biomaterial matrix.

    Several sector/application-specific international and national standards for cell counting currently exist. When applicable, the user can consult existing standards when operating within their scope (specific measurement techniques and/or applications).

    General Product Information - (Show below) - (Hide below)

    Development Note Supersedes ISO/DIS 20391-1. (01/2018)
    Document Type Standard
    Publisher International Organization for Standardization
    Status Current

    Standards Referencing This Book - (Show below) - (Hide below)

    ISO 5725-1:1994 Accuracy (trueness and precision) of measurement methods and results — Part 1: General principles and definitions
    ISO 13366-1:2008 Milk Enumeration of somatic cells Part 1: Microscopic method (Reference method)
    DIN 58932-4:2003-07 HEMATOLOGY - DETERMINATION OF THE CONCENTRATION OF BLOOD CORPUSCLES IN BLOOD - PART 4: REFERENCE PROCEDURE FOR THE DETERMINATION OF THE CONCENTRATION OF LEUCOCYTES
    CLSI H44 A2 : 2ED 2004 METHODS FOR RETICULOCYTE COUNTING (FLOW CYTOMETRY AND SUPRAVITAL DYES)
    ISO 10718:2015 Cork stoppers Characterization of a low-in-germs stopper, through the enumeration of colony-forming units of yeasts, moulds and bacteria, capable of both being extracted and growing in alcoholic medium
    ASTM F 2149 : 2016 : REDLINE Standard Test Method for Automated Analyses of Cells—the Electrical Sensing Zone Method of Enumerating and Sizing Single Cell Suspensions
    ISO 11843-1:1997 Capability of detection Part 1: Terms and definitions
    ISO 13528:2015 Statistical methods for use in proficiency testing by interlaboratory comparison
    ASTM F 2944 : 2012 Standard Test Method for Automated Colony Forming Unit (CFU) Assays—Image Acquisition and Analysis Method for Enumerating and Characterizing Cells and Colonies in Culture
    ISO 5725-3:1994 Accuracy (trueness and precision) of measurement methods and results — Part 3: Intermediate measures of the precision of a standard measurement method
    ISO Guide 33:2015 Reference materials Good practice in using reference materials
    DIN 58932-1:2012-04 Haematology - Determination of the concentration of blood corpuscles in blood - Part 1: Blood collection, sample preparation, biological influence factors, interference factors; Text in German and English
    DIN 58932-5:2007-10 HAEMATOLOGY - DETERMINATION OF THE CONCENTRATION OF BLOOD CORPUSCLES IN BLOOD - PART 5: REFERENCE METHOD FOR THE DETERMINATION OF THE CONCENTRATION OF THROMBOCYTES
    ISO 5725-6:1994 Accuracy (trueness and precision) of measurement methods and results — Part 6: Use in practice of accuracy values
    DIN 58932-2:1998-06 DETERMINATION OF THE CONCENTRATION OF BLOOD CORPUSCLES; CHARACTERISTIC QUANTITIES AND PROPERTIES FOR ERYTHROCYTES (ERYTHROCYTE INDICES)
    ISO/IEC Guide 99:2007 International vocabulary of metrology Basic and general concepts and associated terms (VIM)
    ISO 17511:2003 In vitro diagnostic medical devices Measurement of quantities in biological samples Metrological traceability of values assigned to calibrators and control materials
    DIN 58932-3:2016-01 (Draft) HAEMATOLOGY - DETERMINATION OF THE CONCENTRATION OF BLOOD CORPUSCLES IN BLOOD - PART 3: REFERENCE METHOD FOR THE DETERMINATION OF THE CONCENTRATION OF ERYTHROZYTES
    ASTM F 2739 : 2016 Standard Guide for Quantifying Cell Viability within Biomaterial Scaffolds
    ISO 5725-2:1994 Accuracy (trueness and precision) of measurement methods and results Part 2: Basic method for the determination of repeatability and reproducibility of a standard measurement method
    ISO 8196-3:2009 Milk Definition and evaluation of the overall accuracy of alternative methods of milk analysis Part 3: Protocol for the evaluation and validation of alternative quantitative methods of milk analysis
    ISO/IEC Guide 98-3:2008 Uncertainty of measurement — Part 3: Guide to the expression of uncertainty in measurement (GUM:1995)
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