ISO 11843-5:2008/Amd 1:2017

Overview

ISO 11843-5:2008/Amd 1:2017 is an important international standard that focuses on the capability of detection specifically addressing the methodology in linear and non-linear calibration cases. This document serves as an amendment to the original Part 5 of the ISO 11843 series, published to refine and update methods that support reliable detection capabilities in measurement systems involving both linear and nonlinear calibrations.

Prepared by ISO’s Technical Committee ISO/TC 69, Subcommittee SC 6-specializing in statistical methods and measurement techniques-this amendment clarifies the application of statistical and measurement uncertainty principles when calibrating instruments and analytical methods. Its aim is to enhance the accuracy and reliability of detection limits crucial for quality control, laboratory analysis, and compliance testing.

Key Topics

• Detection Capability: Defines the ability of a measurement procedure to reliably detect a specific signal or quantity.
• Linear and Non-linear Calibration: Detailed methodologies for handling both types of calibration curves used in analytical measurements.
• Uncertainty Propagation: Incorporates updated formulas for calculating how uncertainties in measurement inputs propagate through calibration functions.
• Differential Method Clarifications: Updates corrections on the use of mathematical expressions critical to interpreting detection capability.
• Statistical Parameters: Introduces precise terms, such as coefficient of variation (CV) for different volumetric steps and limits of noise and absorbance variations in measurements.
• Practical Formula Adjustments: Refines equations that estimate standard deviations and error sources relevant for microplate-based assays and pipetting operations.

Applications

The amendments presented in ISO 11843-5:2008/Amd 1:2017 are widely applicable across industries and laboratories that require:

• Analytical Chemistry: Enhancing the quality and accuracy of calibration processes in chemical assays, including absorbance and fluorescence measurements.
• Pharmaceutical Testing: Improving detection limit assessments in drug formulation and quality control.
• Environmental Monitoring: Providing consistent and precise detection capabilities for pollutant measurement using calibrated instruments.
• Food Safety: Supporting detection of contaminants or analytes at trace levels through correct calibration of analytical equipment.
• Clinical Diagnostics: Ensuring reliable detection of biomarkers by refining calibration performance in biochemical assays.
• Manufacturing Quality Control: Assessing instrument detection capabilities to maintain product standards and regulatory compliance.

By integrating this amendment into calibration protocols, organizations can achieve higher confidence in detection limits, improve repeatability, and reduce the risk of errors caused by calibration uncertainties.

Related Standards

When implementing ISO 11843-5:2008/Amd 1:2017, it is useful to consider other related standards in the ISO 11843 series and supporting documents, including:

• ISO 11843-1 – Capability of detection - Part 1: Terms and definitions
• ISO 11843-2 – Capability of detection - Part 2: Methodology for the determination of the critical value for the decision threshold
• ISO 11843-3 – Capability of detection - Part 3: Methodology for the estimation of the detection capability
• ISO 5725 series – Accuracy (trueness and precision) of measurement methods and results
• ISO/IEC 17025 – General requirements for the competence of testing and calibration laboratories
• ISO Guide 98-3 (GUM) – Guide to the expression of uncertainty in measurement

These complementary standards enhance the framework for conducting reliable, reproducible, and compliant detection capability assessments in various scientific and industrial fields.

By adhering to ISO 11843-5:2008/Amd 1:2017, organizations benefit from improved methodologies to handle both linear and non-linear calibration data, reducing uncertainty and strengthening overall measurement quality. This leads to more robust decision-making processes in quality assurance, regulatory compliance, and scientific research.