National foreword

This British Standard is the UK implementation of ISO 24421:2023.

The UK participation in its preparation was entrusted to Technical Committee BTI/1, Biotechnologies.

A list of organizations represented on this committee can be obtained on request to its committee manager.

Contractual and legal considerations

This publication has been prepared in good faith, however no representation, warranty, assurance or undertaking (express or implied) is or will be made, and no responsibility or liability is or will be accepted by BSI in relation to the adequacy, accuracy, completeness or reasonableness of this publication. All and any such responsibility and liability is expressly disclaimed to the full extent permitted by the law.

This publication is provided as is, and is to be used at the recipient’s own risk.

The recipient is advised to consider seeking professional guidance with respect to its use of this publication.

This publication is not intended to constitute a contract. Users are responsible for its correct application.

Compliance with a British Standard cannot confer immunity from legal obligations.

This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 July 2023.

Foreword

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This document was prepared by Technical Committee ISO/TC 276, Biotechnology.

Any feedback or questions on this document should be directed to the user’s national standards body. A complete listing of these bodies can be found at www.iso.org/members.html.

Introduction

This document defines terms and provides general guidance for accurate measurement of optical signals used for analysis of biological samples in photometric methods. These photometric methods can use optical signal measurements, including bioluminescence, chemiluminescence, fluorescence or absorption measurement, that can be applied in the fields of biotechnology, life science and medicine. A measured optical signal value is applied for evaluating biological parameters qualitatively or quantitatively, including cellular and metabolic activities, and gene expressions. Photometric methods are used in applications such as toxicity testing, environmental risk assessment, biomanufacturing, drug development, regenerative medicine and biobanking.

There are significant needs for both manufacturers and users for high quality optical signal measurement in photometric methods in industry to increase confidence in the repeatability, intermediate precision and reproducibility for analysis of biological samples. While repeatability of the photometric method is already sufficient for qualitative characterization of biological samples, quantitative characterization requires more accurate intermediate precision and reproducibility of optical signal measurement. It requires proper optical signal measurements, and it also requires assessment of deviations from the ideal proportionality of the optical signal and the output of the photometric method. Requirements for proper optical signal measurement are an important component of the description of specific applications of photometric methods.

This document provides a general framework to support proper measurement of an optical signal in a photometric method. It focuses on the utilization of optical references and relevant technical issues for optical signal measurement in photometric methods, including procedures for verification of instruments, continual performance monitoring of instruments and photometric method validation. Optical references can be used to verify instruments to increase confidence in the repeatability, intermediate precision, and reproducibility of optical signal measurement. For example, an optical signal emitted from biological samples can be compared on a common measurement scale within a laboratory, between manufacturer and manufacturer, manufacturer and user, or user and user.

1 Scope

This document specifies minimum requirements to support accurate measurement of optical signals in photometric methods used for qualitative or quantitative characterization of biological samples.

This document is applicable to optical signals that are generated, for example, by bioluminescence, chemiluminescence and fluorescence, and optical signals that are detected as changes of light due to absorption.

This document addresses the verification of optical signal measurement instruments used in photometric methods for measurement of biological samples including considerations for the use of optical references.

This document does not provide sector- or application-specific performance criteria for the workflow of measuring biological samples. When applicable, users can also consult existing sector- or application- specific standards, or both.

2 Normative references

3 Terms and definitions

4 Principles

4.1 General

4.2 Instruments and measurements

4.3 Optical references

5 Minimum requirements to support optical signal measurement

5.1 Elements of photometric methods

5.2 Verification of optical signal measurement instruments

5.3 Optical signal measurement of biological samples

5.4 Data analysis and reporting

Bibliography

BS ISO 24421:2023

Biotechnology. Minimum requirements for optical signal measurements in photometric methods for biological samples

Current

Published:

31 Jul 2023