We noticed you’re not on the correct regional site. Switch to our AMERICAS site for the best experience.
  • ENV ISO 13843 : DRAFT MAY 2001

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
    Add to Watchlist
    This Standard has been added successfully to your Watchlist.
    Please visit My Watchlist to see all standards that you are watching.
    Please log in or to add this standard to your Watchlist.
    We could not add this standard to your Watchlist.
    Please retry or contact support for assistance.
    You need to be logged in to add this standard to your Watchlist.
    Please log in now or create an account to add.
    You already added this Product in the Watchlist.

    WATER QUALITY - GUIDANCE ON VALIDATION OF MICROBIOLOGICAL METHODS

    Available format(s): 

    Superseded date:  01-07-2017

    Language(s): 

    Published date:  12-01-2013

    Publisher:  Comite Europeen de Normalisation

    Add to Watchlist
    Pure ENs are not available for sale, please purchase a suitable national adoption

    Sorry this product is not available in your region.

    Add To Cart

    Table of Contents - (Show below) - (Hide below)

    Foreword
    1 Scope
    2 Terms and definitions
    3 Arrangement of the document
    4 Basic concepts
       4.1 Basic concepts
       4.2 Validation
       4.3 Detectors
       4.4 Performance characteristics
       4.5 Specifications
    5 Limitations and characteristics features of
       microbiological methods
       5.1 Recovery of the analyte
       5.2 Sample variance
       5.3 Particle distribution and over dispersion
       5.4 Interactions in the detector
       5.5 Robustness
       5.6 Spurious errors
       5.7 Control and guidance charts
    6 Mathematical models of variation
       6.1 Unavoidable basic variation - The Poisson
            distribution
       6.2 Over dispersion - The negative binomial model
       6.3 Statistical and practical limits
       6.4 General tests for randomness - Detection of
            over dispersion
    7 Specifications - Current practice
    8 Specifications - Recommended approach
    9 Determination and expression of performance
       characteristics
       9.1 General
       9.2 Categorical characteristics related to specifity
            and selectivity
       9.3 Working limits
       9.4 Working range of MPN procedures
       9.5 Precision
    10 Procedures and steps of validation
       10.1 General
       10.2 Primary validation
       10.3 Secondary validation
    11 Designs for determining specifications
       11.1 A general model for basic quantitative
            specifications
       11.2 Precision of the entire analytical procedure
       11.3 Categorical characteristics
       11.4 Unplanned data
    Annex A Statistical procedures and computer programs
    Annex B Numerical examples
    Annex C Example of a validation experiment
    Bibliography

    Abstract - (Show below) - (Hide below)

    Deals with the validation of microbiological methods, with particular emphasis on selective quantitative methods in which the quantitative estimate is based on counting of particles either directly, with the aid of a microscope, or indirectly, on the basis of growth into colonies or turbidity.

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

    Comment Closes On
    Committee TC 230
    Document Type Draft
    Publisher Comite Europeen de Normalisation
    Status Superseded

    Standards Referenced By This Book - (Show below) - (Hide below)

    BS PD CEN/TR 16193 : 2013 SLUDGE, TREATED BIOWASTE AND SOIL - DETECTION AND ENUMERATION OF ESCHERICHIA COLI
    S.R. CEN/TR 16193:2013 SLUDGE, TREATED BIOWASTE AND SOIL - DETECTION AND ENUMERATION OF ESCHERICHIA COLI
    CEN/TR 16193 : 2013 SLUDGE, TREATED BIOWASTE AND SOIL - DETECTION AND ENUMERATION OF ESCHERICHIA COLI
    VDI 4256-1 : 2010 BIOAEROSOLS AND BIOLOGICAL AGENTS - DETERMINATION OF PERFORMANCE CHARACTERISTICS - CULTURE-BASED COUNTING METHODS
    • Access your standards online with a subscription

      Features

      • Simple online access to standards, technical information and regulations
      • Critical updates of standards and customisable alerts and notifications
      • Multi - user online standards collection: secure, flexibile and cost effective