{"id":364228,"date":"2024-10-20T01:49:38","date_gmt":"2024-10-20T01:49:38","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bsi-pd-cen-ts-168002020\/"},"modified":"2024-10-26T02:53:24","modified_gmt":"2024-10-26T02:53:24","slug":"bsi-pd-cen-ts-168002020","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bsi-pd-cen-ts-168002020\/","title":{"rendered":"BSI PD CEN\/TS 16800:2020"},"content":{"rendered":"

This document describes an approach for the validation of physico-chemical analytical methods for environmental solid matrices and water.<\/p>\n

The guidance in this document addresses the initial description of the method and two different validation approaches, in increasing order of complexity. These are:<\/p>\n

    \n
  1. \n

    method development, if the method is developed by the laboratory, or conditions of adoption, if the method is a standardized protocol adopted by the laboratory;<\/p>\n<\/li>\n

  2. \n

    validation at the level of single laboratories (within-laboratory validation);<\/p>\n<\/li>\n

  3. \n

    method validation at the level of several laboratories (between-laboratory or inter-laboratory validation), with a focus on methods that are sufficiently mature and robust to be applied not only by a few expert laboratories but by laboratories operating at the routine level.<\/p>\n<\/li>\n<\/ol>\n

    The concept is strictly hierarchical, i.e. a method shall fulfil all criteria of within-laboratory validation before it can enter the validation protocol of the between-laboratory.<\/p>\n

    This document is applicable to the validation of a broad range of quantitative physico-chemical test methods for the analysis of water (including drinking water, surface water, groundwater, waste water, marine water), and of solid environmental matrices, such as soil, sludge, liquid and solid waste, sediment and biota. It is intended for standardized protocols adopted by a laboratory, and either for test methods aiming at substances that have recently become of interest or for test methods applying recently developed technologies.<\/p>\n

    The minimal requirements that are indispensable for the characterization of the fitness for the intended purpose of an analytical method are: selectivity, precision, trueness, performances characteristics and measurement uncertainty. The aim of validation is to prove that these requirements are met.<\/p>\n

    In this document after the definitions (Clause 3<\/span>) and description of the principles (Clause 4<\/span>) a toolbox is given describing the relevant performance characteristics in the validation process.<\/p>\n

    Clause 7<\/span> and 8<\/span> focus on the within laboratory validation process (V1) and Clause 9<\/span> on the interlaboratory validation process (V2). Clause 7<\/span> and 8<\/span> describe largely the same processes, but differ in approach for establishing the LOQ.<\/p>\n

    Reporting of the results of the validation studies is addressed in Clause 10<\/span>.<\/p>\n

    PDF Catalog<\/h4>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
    PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
    2<\/td>\nNational foreword <\/td>\n<\/tr>\n
    6<\/td>\nEuropean foreword <\/td>\n<\/tr>\n
    7<\/td>\nIntroduction <\/td>\n<\/tr>\n
    8<\/td>\n1 Scope
    2 Normative references
    3 Terms and definitions <\/td>\n<\/tr>\n
    15<\/td>\n4 Principle <\/td>\n<\/tr>\n
    16<\/td>\n5 Characterization toolbox: performance characteristics
    5.1 Introduction
    5.2 Characteristics
    5.2.1 Selectivity <\/td>\n<\/tr>\n
    17<\/td>\n5.2.2 Sensitivity
    5.2.3 Robustness
    5.2.4 Trueness <\/td>\n<\/tr>\n
    19<\/td>\n5.2.5 Precision
    5.2.6 Limit values <\/td>\n<\/tr>\n
    20<\/td>\n5.2.7 Calibration
    5.2.8 Application range
    5.2.9 Measurement uncertainty <\/td>\n<\/tr>\n
    21<\/td>\n6 Method development <\/td>\n<\/tr>\n
    22<\/td>\n7 Intra-laboratory validation (V1) \u2013 option 1, basic procedure
    7.1 General
    7.1.1 Validation 1
    7.1.2 Adoption of a standardized method <\/td>\n<\/tr>\n
    23<\/td>\n7.1.3 Extension of the application domain of an intra-laboratory validated method
    7.1.4 Complete in-house development
    7.2 Intra-laboratory performance characteristics
    7.2.1 General
    7.2.2 Trueness <\/td>\n<\/tr>\n
    24<\/td>\n7.2.3 Precision <\/td>\n<\/tr>\n
    25<\/td>\n7.2.4 LOD, LOQ <\/td>\n<\/tr>\n
    26<\/td>\n7.2.5 Measurement uncertainty
    8 Intra-laboratory validation (V1) \u2013 option 2, including verification of the LOQ
    8.1 General
    8.2 LOQ-V <\/td>\n<\/tr>\n
    27<\/td>\n9 Interlaboratory validation 2 (V2)
    9.1 General <\/td>\n<\/tr>\n
    28<\/td>\n9.2 Procedure
    9.2.1 Participating laboratories <\/td>\n<\/tr>\n
    29<\/td>\n9.2.2 Materials: selection, preparation and pre-testing of samples
    9.2.3 Replicates <\/td>\n<\/tr>\n
    30<\/td>\n9.2.4 Characteristics of the inter-laboratory study
    9.2.5 Assigned values
    9.2.6 Statistical evaluation and calculation of the results <\/td>\n<\/tr>\n
    31<\/td>\n10 Validation report
    10.1 General <\/td>\n<\/tr>\n
    32<\/td>\n10.2 Module A: Test method definition, documentation and general requirements
    10.3 Module B: Applicability domain validation <\/td>\n<\/tr>\n
    33<\/td>\n10.4 Module C: Intra-laboratory performance
    10.5 Inter-laboratory validation
    10.5.1 General <\/td>\n<\/tr>\n
    34<\/td>\n10.5.2 Documentation, publication and standardization <\/td>\n<\/tr>\n
    35<\/td>\nAnnex A (normative) Intra-laboratory validation <\/td>\n<\/tr>\n
    39<\/td>\nAnnex B (normative) Module C: Intra-laboratory performance <\/td>\n<\/tr>\n
    40<\/td>\nAnnex C (normative) Module D: Requirements on the study for inter-laboratory validation <\/td>\n<\/tr>\n
    43<\/td>\nAnnex D (informative) Structure and content of a validation study documentation (V2) <\/td>\n<\/tr>\n
    47<\/td>\nAnnex E (informative) Robustness testing by systematic variation of influencing factors <\/td>\n<\/tr>\n
    49<\/td>\nAnnex F (informative) Protocol for spiking of solid matrices <\/td>\n<\/tr>\n
    50<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

    Guideline for the validation of physico-chemical analytical methods<\/b><\/p>\n\n\n\n\n
    Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
    BSI<\/b><\/a><\/td>\n2021<\/td>\n52<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":364237,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[216,2641],"product_tag":[],"class_list":{"0":"post-364228","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-13-060-50","7":"product_cat-bsi","9":"first","10":"instock","11":"sold-individually","12":"shipping-taxable","13":"purchasable","14":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/364228","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media\/364237"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=364228"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=364228"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=364228"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}