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Commission Decisionof 12 August 2002implementing 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)

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  1. Introductory Text

  2. Article 1.Subject matter and scope

  3. Article 2.Definitions

  4. Article 3.Analytical methods

  5. Article 4.Minimum required performance limits

  6. Article 5.Quality control

  7. Article 6.Interpretation of results

  8. Article 7.Repeal

  9. Article 8.Transitional provisions

  10. Article 9.Date of application

  11. Article 10.Addressees

  12. Signature

    1. ANNEX I

      PERFORMANCE CRITERIA, OTHER REQUIREMENTS AND PROCEDURES FOR ANALYTICAL METHODS

      1. 1. DEFINITIONS

        1. 1.1. Accuracy means the closeness of agreement between a test result...

        2. 1.2. Alpha (ɑ) error means the probability that the tested sample...

        3. 1.3. Analyte means the substance that has to be detected, identified...

        4. 1.4. Beta (β) error means the probability that the tested sample...

        5. 1.5. Bias means the difference between the expectation of the test...

        6. 1.6. Calibration standard means a device for measurements that represents the...

        7. 1.7. Certified reference material (CRM) means a material that has had...

        8. 1.8. Co-chromatography means a procedure in which the extract prior to...

        9. 1.9. Collaborative study means analysing the same sample by the same...

        10. 1.10. Confirmatory method means methods that provide full or complementary information...

        11. 1.11. Decision limit (CCɑ) means the limit at and above which...

        12. 1.12. Detection capability (CCβ) means the smallest content of the substance...

        13. 1.13. Fortified sample material means a sample enriched with a known...

        14. 1.14. Interlaboratory study (comparison) means organisation, performance and evaluation of tests...

        15. 1.15. Internal Standard (IS) means a substance not contained in the...

        16. 1.16. Laboratory sample means a sample prepared for sending to a...

        17. 1.17. Level of interest means the concentration of substance or analyte...

        18. 1.18. Minimum required performance limit (MRPL) means minimum content of an...

        19. 1.19. Performance characteristic means functional quality that can be attributed to...

        20. 1.20. Performance criteria means requirements for a performance characteristic according to...

        21. 1.21. Permitted limit means maximum residue limit, maximum level or other...

        22. 1.22. Precision means the closeness of agreement between independent test results...

        23. 1.23. Proficiency study means analysing the same sample allowing laboratories to...

        24. 1.24. Qualitative method means an analytical method which identifies a substance...

        25. 1.25. Quantitative method means an analytical method which determines the amount...

        26. 1.26. Reagent blank determination means the complete analytical procedure applied without...

        27. 1.27. Recovery means the percentage of the true concentration of a...

        28. 1.28. Reference material means a material of which one or several...

        29. 1.29. Repeatability means precision under repeatability conditions (2).

        30. 1.30. Repeatability conditions means conditions where independent test results are obtained...

        31. 1.31. Reproducibility means precision under reproducibility conditions (2)(4).

        32. 1.32. Reproducibility conditions means conditions where test results are obtained with...

        33. 1.33. Ruggedness means the susceptibility of an analytical method to changes...

        34. 1.34. Sample blank determination means the complete analytical procedure applied to...

        35. 1.35. Screening method means methods that are used to detect the...

        36. 1.36. Single laboratory study (in-house validation) means an analytical study involving...

        37. 1.37. Specificity means the ability of a method to distinguish between...

        38. 1.38. Standard addition means a procedure in which the test sample...

        39. 1.39. Standard analyte means an analyte of known and certified content...

        40. 1.40. Substance means matter of particular or definite chemical constitution and...

        41. 1.41. Test portion means the quantity of material drawn from the...

        42. 1.42. Test sample means a sample prepared from a laboratory sample...

        43. 1.43. Trueness means the closeness of agreement between the average value...

        44. 1.44. Units means those units described in ISO 31 (20) and...

        45. 1.45. Validation means the confirmation by examination and the provision of...

        46. 1.46. Within-laboratory reproducibility means precision obtained in the same laboratory under...

      2. 2. PERFORMANCE CRITERIA AND OTHER REQUIREMENTS FOR ANALYTICAL METHODS

        1. 2.1. GENERAL REQUIREMENTS

          1. 2.1.1 Handling of samples

          2. 2.1.2 Performance of tests

          3. 2.1.2.1 Recovery

          4. 2.1.2.2 Specificity

        2. 2.2. SCREENING METHODS

        3. 2.3. CONFIRMATORY METHODS FOR ORGANIC RESIDUES AND CONTAMINANTS

          1. 2.3.1 Common performance criteria and requirements

          2. 2.3.2 Additional performance criteria and other requirements for quantitative methods of...

          3. 2.3.2.1 Trueness of quantitative methods

          4. 2.3.2.2 Precision of quantitative methods

          5. 2.3.3 Performance criteria and other requirements for mass spectrometric detection

          6. 2.3.3.1 Chromatographic separation

          7. 2.3.3.2 Mass spectrometric detection

          8. 2.3.4 Performance criteria and other requirements for chromatography coupled to infrared...

          9. 2.3.4.1 Infra-red detection

          10. 2.3.4.2 Interpretation of infra-red spectral data

          11. 2.3.5 Performance criteria and other requirements for the determination of an...

          12. 2.3.5.1 Chromatographic separation

          13. 2.3.5.2 Full-scan UV/VIS detection

          14. 2.3.5.3 Performance criteria for fluorimetric detection

          15. 2.3.5.4 Performance criteria for the determination of an analyte by an...

          16. 2.3.5.5 Determination of an analyte using LC with UV/VIS detection (single...

          17. 2.3.6 Performance criteria and other requirements for the determination of an...

          18. 2.3.7 Performance criteria and requirements for the determination of an analyte...

        4. 2.4. CONFIRMATORY METHODS FOR ELEMENTS

          1. 2.4.1 Common performance criteria and other requirements for confirmatory methods

          2. 2.4.2 Additional performance criteria and other requirements for quantitative methods of...

          3. 2.4.2.1 Trueness of quantitative methods

          4. 2.4.2.2 Precision of quantitative methods

          5. 2.4.3 Specific requirements for differential pulse anodic stripping voltametry (DPASV)

          6. 2.4.4 Specific requirements for atomic absorption spectrometry (AAS)

          7. 2.4.4.1 Specific requirements for flame AAS

          8. 2.4.4.2 Specific requirements for graphite furnace AAS

          9. 2.4.5 Specific requirements for hydride generation atomic absorption spectrometry

          10. 2.4.6 Specific requirements for cold vapour atomic absorption spectrometry

          11. 2.4.7 Specific requirements for inductively coupled plasma atomic emission spectrometry (ICP-AES)...

          12. 2.4.8 Specific requirements for inductively coupled mass spectrometry (ICP-MS)(11))

      3. 3. VALIDATION

        1. 3.1. VALIDATION PROCEDURES

          1. 3.1.1 Model-independent performance characteristics

          2. 3.1.1.1 Specificity

          3. 3.1.1.2 Trueness

          4. 3.1.1.3 Applicability/ruggedness (minor changes)

          5. 3.1.1.4 Stability

          6. 3.1.1.5 Calibration curves

          7. 3.1.2 Conventional validation procedures

          8. 3.1.2.1 Recovery

          9. 3.1.2.2 Repeatability

          10. 3.1.2.3 Within-laboratory reproducibility

          11. 3.1.2.4 Reproducibility

          12. 3.1.2.5 Decision Limit (CCɑ)

          13. 3.1.2.6 Detection capability (CCβ)

          14. 3.1.2.7 Ruggedness (major changes)

          15. 3.1.3 Validation according to alternative models

          16. 3.1.3.1 Experimental plan

          17. 3.1.3.2 Power curve

          18. 3.1.3.3 Reproducibility

        2. 3.2. GRAPHICAL REPRESENTATION OF THE DIFFERENT ANALYTICAL LIMITS

        3. 3.3. CALCULATION EXAMPLE FOR RUGGEDNESS TESTING OF MINOR CHANGES ACCORDING TO THE YOUDEN APPROACH (16)

          1. Standard deviation of the differences Di (SDi):

        4. 3.4. CALCULATION EXAMPLES FOR THE IN-HOUSE VALIDATION PROCEDURE

        5. 3.5. EXAMPLES FOR THE STANDARD ADDITION METHOD

      4. 4. ABBREVIATIONS USED

      5. 5. REFERENCES

    2. ANNEX II

      Minimum required performance limits

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