{
  "url": "https://openlegislation.uk/eu-decision-2002-657/annex/chapter-3.1",
  "json_url": "https://openlegislation.uk/eu-decision-2002-657/annex/chapter-3.1.json",
  "legislation": "eudn/2002/657",
  "legislation_title": "Commission Decision of 12 August 2002 implementing Council Directive 96/23/EC concerning the performance of analytical methods and the interpretation of results (notified under document number C(2002) 3044) (Text with EEA relevance) (2002/657/EC)",
  "legislation_url": "https://openlegislation.uk/eu-decision-2002-657",
  "path": "annex/chapter/3.1",
  "kind": "chapter",
  "number": "3.1.",
  "heading": "VALIDATION PROCEDURES",
  "text": "This chapter provides examples and/or references for validation procedures of analytical methods. Other approaches to demonstrate that the analytical method complies with performance criteria for the performance characteristics may be used, provided that they achieve the same level and quality of information.\nValidation can also be performed by conducting an interlaboratory study such as established by Codex Alimentarius, ISO or the IUPAC (12), or according to alternative methods such as single laboratory studies or in-house validation (13)(14). This part focuses on single laboratory studies (on in-house validation) using a modular approach. This approach consists of:\n1. a set of common performance characteristics independent of the validation model used and\n2. more specific model-dependent procedures as described in Table 10.\nTable 10\nModel-independent and model-dependent performance parameters\nValidation\nModel-independent performance parameters\nModel-dependent performance parameters\nCommon performance characteristics (3.1.1)\nConventional validation approach (3.1.2)\nIn-house validation approach (3.1.3)\nSpecificity\nRecovery\nRecovery\nTrueness\nRepeatability\nRepeatability\nRuggedness: minor changes\nWithin-laboratory reproducibility\nWithin-laboratory reproducibility\nStability\nReproducibility\nReproducibility\nDecision limit (CC α)\nDecision limit (CC α)\nDetection capability (CCβ)\nDetection capability (CCβ)\nCalibration curves\nCalibration curve\nRuggedness: major changes\nRuggedness",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudn/2002/657/annex/chapter/3.1",
    "retrieved_at": "2026-11-01T15:18:31.211349+00:00"
  },
  "licence": "Open Government Licence v3.0",
  "licence_url": "https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/",
  "attribution": "Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives."
}