ISO 13843-2017 PDF
Name in English:
St ISO 13843-2017
Name in Russian:
Ст ISO 13843-2017
Original standard ISO 13843-2017 in PDF full version. Additional info + preview on request
Full title and description
Water quality — Requirements for establishing performance characteristics of quantitative microbiological methods. This international standard specifies procedures and experimental designs to determine performance characteristics (categorical and quantitative) of microbiological methods used for water analysis, supporting method characterization, subsequent validation or single‑laboratory verification.
Abstract
ISO 13843:2017 provides guidance on how to characterize quantitative microbiological methods (microscopic counts, colony counts, MPN and similar counting‑based approaches) by defining measurable performance characteristics such as sensitivity, specificity, working range, limits of detection, repeatability and reproducibility, robustness and uncertainty of counting. It includes recommended experimental designs, worked examples and normative annexes for assessing upper/lower limits, variability and uncertainty.
General information
- Status: International Standard (published / in force).
- Publication date: June 2017.
- Publisher: International Organization for Standardization (ISO).
- ICS / categories: 07.100.20 — Microbiology of water.
- Edition / version: First edition, ISO 13843:2017.
- Number of pages: 61 pages.
Scope
ISO 13843:2017 applies to the characterization of quantitative microbiological methods for all types of water and is primarily intended for methods based on counting (direct microscopic counts, colony counts, most probable number and analogous counting approaches). The standard describes procedures to determine categorical performance (sensitivity, specificity, selectivity, false positive/negative rates) and quantitative performance (working range, upper/lower limits of detection, linearity), as well as precision, robustness and uncertainty of counting. Applicability to non‑counting or novel counting approaches should be assessed case‑by‑case.
Key topics and requirements
- Definitions and basic concepts for characterization, verification and method comparison.
- Experimental designs and sample selection criteria for determining categorical performance (sensitivity, specificity, efficiency, selectivity, false positive/negative rates).
- Determination of working range, upper limit (linearity) and consideration of the lower limit of detection.
- Assessment of precision: repeatability, intralaboratory reproducibility and interlaboratory reproducibility (collaborative studies).
- Robustness testing (operational variability: time, temperature and procedural variations).
- Uncertainty of counting for colony counts and MPN results, with normative annexes giving mathematical models and worked examples.
- Guidance for single‑laboratory verification and design of collaborative performance studies.
Typical use and users
Laboratories performing routine water microbiology testing, method developers and manufacturers of microbiological assays, accreditation bodies and quality managers (e.g., under ISO/IEC 17025), and organizations conducting interlaboratory studies or establishing method performance claims. The standard is used when documenting method performance during development, validation, verification or transfer.
Related standards
ISO 13843:2017 is connected to other water microbiology and method‑validation documents (for example ISO 17994 on comparison of methods and various ISO and CEN standards for specific microbiological test methods). It replaces earlier technical reports and guidance documents on method characterization (it cancels and replaces ISO/TR 13843:2000 and supersedes prior ENV documents in its subject area).
Keywords
Water quality; microbiological methods; quantitative methods; method characterization; validation; sensitivity; specificity; limit of detection; working range; repeatability; reproducibility; uncertainty of counting.
FAQ
Q: What is this standard?
A: ISO 13843:2017 is an international standard titled "Water quality — Requirements for establishing performance characteristics of quantitative microbiological methods" that gives procedures and designs for characterizing the performance of counting‑based microbiological methods used in water analysis.
Q: What does it cover?
A: It covers definitions, performance characteristics (categorical and quantitative), experimental designs for determining sensitivity, specificity, working range and limits of detection, precision (repeatability and reproducibility), robustness and uncertainty of counting, plus annexes with mathematical models and worked examples.
Q: Who typically uses it?
A: Water testing laboratories, method developers and manufacturers, accreditation bodies, quality managers and organizers of collaborative studies who need to establish or verify method performance.
Q: Is it current or superseded?
A: ISO 13843:2017 is the current (2017) edition; it cancelled and replaced the earlier ISO/TR 13843:2000 and updated prior technical/environmental reports on the topic. Users should check for any amendments or later revisions before relying on the standard for regulatory or compliance purposes.
Q: Is it part of a series?
A: It is part of the ISO/TC 147 family of water quality standards and relates to other ISO standards and CEN documents that address specific microbiological methods, method comparison and validation. National or regional endorsements (for example as EN ISO) exist in some jurisdictions.
Q: What are the key keywords?
A: Water quality, quantitative microbiological methods, performance characteristics, sensitivity, specificity, limit of detection, working range, repeatability, reproducibility, uncertainty.