ISO 8196-3:2022 PDF

Milk — Definition and evaluation of the overall accuracy of alternative methods of milk analysis — Part 3: Protocol for the evaluation and validation of alternative quantitative methods of milk analysis

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Title (English):

ISO 8196-3:2022

Document status:: Active
Format:: Electronic (PDF)
Number of pages:: 36
Publication date:: May 11, 2022
Edition:: ISO IS 8196 edition 2 version 1
ICS:: 67.100.10

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Description (English):

This document specifies a protocol for the evaluation and validation of alternative quantitative methods of milk analysis. This document is also applicable for the validation of new alternative methods where, due to a limited number of operational instruments, the execution of an interlaboratory study and ISO 8196-1 | IDF 128-1 is not feasible. The protocol is applicable to milk parameters such as, for example, fat, protein, lactose, urea and somatic cells in milk. It can also be extended to other parameters. This document also establishes the general principles of a procedure for granting international approvals for the performance of the alternative methods. These principles are based on the validation protocol defined in this document.

Technical details

Technical committee: ISO/TC 34/SC 5 - Milk and milk products
SKU: ISO 8196-3:2022

Abstract

Overview

ISO 8196-3:2022 (IDF 128-3:2022) specifies a harmonized protocol for the evaluation and validation of alternative quantitative methods of milk analysis. It is intended where classical interlaboratory studies (ISO 8196-1 | IDF 128-1) are not feasible-for example when only a limited number of operational instruments are available. The standard covers validation steps, performance criteria and a route to national and international approval for methods measuring milk parameters such as fat, protein, lactose, urea and somatic cells (and can be extended to other measurands).

Keywords: ISO 8196-3:2022, milk analysis, validation protocol, alternative methods, quantitative methods, milk parameters.

Key topics and technical requirements

Two-phase validation protocol
- Phase I - Methods comparison study: Expert laboratory compares the alternative method against the reference method or a validated instrument under test-bed conditions; assesses performance characteristics.
- Phase II - Method confirmation study: Confirms precision and performance in routine testing conditions after successful Phase I.
Performance characteristics and assessment: The protocol lists compulsory assessments and additional informative investigations, with guidance for statistical compliance.
Roles and competence
- Expert laboratory: Qualified staff and equipment; should conform to ISO/IEC 17025 and have relevant experience.
- Organizing laboratory: Responsible for interlaboratory studies when applicable and for sample homogeneity checks.
Approval principles: General principles for granting national and international approvals are established, based on the validation protocol.
Supporting materials: Annexes contain measurement-process descriptions, indicative performance limits for raw milk, calculation examples and procedures (e.g., linearity sample preparation).

Practical applications and users

Who uses it:
- Dairy testing laboratories developing or adopting alternative analytical instruments (e.g., milk payment analyzers, milk recording devices).
- Manufacturers seeking official validation/approval for new milk analysis instruments.
- Regulatory bodies and approval organizations evaluating methods for official use.
Typical use cases:
- Validating a new instrument generation when only a few units exist.
- Demonstrating method accuracy, trueness and precision for routine milk testing (fat, protein, lactose, urea, somatic cell count).
- Supporting applications for national or international approval of alternative quantitative milk analysis methods.

Related standards

ISO 8196-1 | IDF 128-1 - Analytical attributes of alternative methods (complementary)
ISO 8196-2 | IDF 128-2 - Calibration and quality control in the dairy laboratory
ISO/IEC 17025 - Competence of testing and calibration laboratories

This standard provides a practical, criteria-based approach to validate alternative milk analysis methods where full interlaboratory studies are impractical, enabling consistent approvals and reliable routine testing.

Related standards

Standards mentioned in the description

Abstract

Overview

Keywords: ISO 8196-3:2022, milk analysis, validation protocol, alternative methods, quantitative methods, milk parameters.

Key topics and technical requirements

Two-phase validation protocol
- Phase I - Methods comparison study: Expert laboratory compares the alternative method against the reference method or a validated instrument under test-bed conditions; assesses performance characteristics.
- Phase II - Method confirmation study: Confirms precision and performance in routine testing conditions after successful Phase I.
Performance characteristics and assessment: The protocol lists compulsory assessments and additional informative investigations, with guidance for statistical compliance.
Roles and competence
- Expert laboratory: Qualified staff and equipment; should conform to ISO/IEC 17025 and have relevant experience.
- Organizing laboratory: Responsible for interlaboratory studies when applicable and for sample homogeneity checks.
Approval principles: General principles for granting national and international approvals are established, based on the validation protocol.
Supporting materials: Annexes contain measurement-process descriptions, indicative performance limits for raw milk, calculation examples and procedures (e.g., linearity sample preparation).

Practical applications and users

Who uses it:
- Dairy testing laboratories developing or adopting alternative analytical instruments (e.g., milk payment analyzers, milk recording devices).
- Manufacturers seeking official validation/approval for new milk analysis instruments.
- Regulatory bodies and approval organizations evaluating methods for official use.
Typical use cases:
- Validating a new instrument generation when only a few units exist.
- Demonstrating method accuracy, trueness and precision for routine milk testing (fat, protein, lactose, urea, somatic cell count).
- Supporting applications for national or international approval of alternative quantitative milk analysis methods.

Related standards

ISO 8196-1 | IDF 128-1 - Analytical attributes of alternative methods (complementary)
ISO 8196-2 | IDF 128-2 - Calibration and quality control in the dairy laboratory
ISO/IEC 17025 - Competence of testing and calibration laboratories

ISO 8196-3:2022 PDF

Technical details

Abstract

Overview

Key topics and technical requirements

Practical applications and users

Related standards

Related standards

Abstract

Overview

Key topics and technical requirements

Practical applications and users

Related standards

Related standards

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