Overview
EN ISO 23783-1:2023 defines essential terminology and general requirements for automated liquid handling systems (ALHS). Applicable across all laboratory ALHS that are fully assembled and equipped to deliver precise liquid volumes without human intervention, this standard is foundational for ensuring consistency and quality in automated laboratory processes. It supports manufacturers, users, and certification bodies in establishing a common language and understanding, enhancing calibration, validation, and operational reliability in chemical, clinical, and research laboratories.
Key Topics
- Standardized Vocabulary: Establishes clear terms and definitions specific to ALHS, covering concepts like accuracy, precision, calibration, air displacement, liquid classes, and system components.
- Types of ALHS: Describes main categories, including piston-operated, pump-operated, inkjet-type, and acoustic droplet ejection systems. Also provides guidance on pipette tips (air-displacement, positive displacement, fixed tips).
- General Requirements: Outlines specifications for installation, operation, adjustment, and maintenance of ALHS. Provides guidance on cleaning reusable components and managing exchangeable system parts.
- Environmental Conditions: Sets environmental requirements and site-specific considerations to ensure the correct functioning and performance of ALHS.
- Testing and Calibration: Details required practices for calibration, routine testing, metrological confirmation, and performance reporting, emphasizing the importance of adherence to defined procedures for result consistency.
Applications
The standard has broad applications across industries that rely on high-throughput, precise, and reproducible liquid handling, such as:
- Clinical Diagnostics: Supports automation in sample preparation, reagent dispensing, and assay setup, critical for high-volume and regulated laboratory environments.
- Pharmaceutical Research: Facilitates drug discovery workflows by standardizing liquid handling for compound dispensing, dilution, and mixing.
- Molecular Biology and Genomics: Ensures reliability in pipetting small volumes for PCR, NGS library preparation, and qPCR assays.
- Chemical Analysis: Enhances consistency and traceability in chemical laboratories performing routine testing or complex analyses.
- Quality Control: Offers a benchmark for manufacturers and testing organizations, aiding in acceptance testing, routine maintenance, and calibration protocols.
By adhering to EN ISO 23783-1:2023, laboratories and manufacturers benefit from improved data integrity, reduced variability, and harmonized adoption of automated technology.
Related Standards
- ISO 23783-2: Provides detailed measurement procedures for the determination of volumetric performance in ALHS.
- ISO 23783-3: Outlines the specification, determination, and reporting of volumetric performance, building upon the definitions and processes introduced in Part 1.
- ANSI/SLAS Microplate Standards: Establishes dimensions and tolerances for microplates used with many ALHS.
- ISO/IEC Guide 99: Reference for standardized measurement and calibration terminology.
- ISO/IEC Guide 98-3: Guidance on the estimation of measurement uncertainty relevant to ALHS performance.
Practical Value
- Improved Communication: Enables consistent terminology for users, manufacturers, and test bodies, facilitating clear communication and efficient technology transfer.
- Regulatory Compliance: Aids in meeting national and international laboratory accreditation and quality assurance requirements.
- Operational Efficiency: Promotes best practices for installation, operation, and maintenance, boosting reliability and uptime for automated systems.
- Benchmarking and Interoperability: Establishes a reference framework for comparing ALHS capabilities, supporting the integration of equipment from different suppliers.
By implementing EN ISO 23783-1:2023, organizations enhance the robustness and consistency of automated liquid handling processes, leading to better results and streamlined laboratory operations.