ISO 20391-1:2018
Current
The latest, up-to-date edition.
Biotechnology — Cell counting — Part 1: General guidance on cell counting methods
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English
19-01-2018
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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).
| Committee |
ISO/TC 276/SC 1
|
| DevelopmentNote |
Supersedes ISO/DIS 20391-1. (01/2018)
|
| DocumentType |
Standard
|
| Pages |
16
|
| PublisherName |
International Organization for Standardization
|
| Status |
Current
|
| Standards | Relationship |
| NEN ISO 20391-1 : 2018 | Identical |
| UNI ISO 20391-1:2021 | Identical |
| BS ISO 20391-1:2018 | Identical |
| IS/ISO 20391 : Part 1 : 2018 | Identical |
| 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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