Overview
EN ISO 23783-3:2023 (adopted from ISO 23783-3:2022) is a CEN European standard for automated liquid handling systems (ALHS) that defines requirements and guidance for the determination, specification and reporting of volumetric performance. The document covers how to collect, index, analyze and report volumetric delivery data for complete, installed liquid handling devices (including tips and other delivery components) that operate without human intervention into labware. It is part of the ISO 23783 series and supersedes prior guidance in IWA 15:2015.
Key Topics and Requirements
- Volumetric performance assessment: Guidance on measuring delivered volumes and evaluating results to assess trueness and precision.
- Data collection and examination: Requirements for how volumetric data should be collected, including necessary contextual information (e.g., test liquid properties).
- Indexing and tracking: Methods to index data for traceability from both the channel perspective and the microplate perspective, enabling systematic tracking over time.
- Descriptive statistics: Prescribed statistics for evaluation at multiple levels:
- Individual channel statistics (average volume, systematic error, random error)
- Run-order based statistics
- Whole data set summaries and inter-channel differences
- Considerations for volume increments
- Reporting requirements: Standardized content for test reports and calibration certificates, including as-found / as-left reporting and recommendations for calibration intervals.
- Test liquid specification: Reports must describe the test liquid (e.g., aqueous vs solvent, additives) because physical properties affect volumetric performance.
- Qualified personnel: Tests and assessments are intended to be performed by trained staff.
Applications and Who Uses It
- Laboratories: Validation, routine verification and quality control of ALHS used in life sciences, clinical, pharmaceutical and analytical labs.
- Manufacturers: Acceptance testing, production quality control and specification of device performance.
- Calibration/test houses and certification bodies: Standardized protocols for third‑party calibration, certification and reporting.
- Process engineers and lab automation specialists: Use the statistical and indexing guidance to monitor system stability, identify channel drift, and plan maintenance or recalibration.
Related Standards
- ISO 23783-1 - Terminology and general requirements for ALHS (referenced for definitions).
- ISO 23783-2 - Measurement procedures for determination of volumetric performance (procedural methods).
Keywords: EN ISO 23783-3:2023, automated liquid handling systems, ALHS, volumetric performance, calibration, descriptive statistics, reporting requirements, laboratory automation.
