ISO 10991:2023 PDF

Overview

ISO 10991:2023 (Second edition) is the International Organization for Standardization's vocabulary standard for microfluidics and micro process engineering. It defines terms and definitions used across medical and veterinary diagnostics, chemistry, agriculture, pharmacy, biotechnology and the agrifood industry, as well as other application areas. The second edition updates and expands the first edition (2009), adding new terms to reflect the increased uptake of microfluidic technology.

Why this matters: a common vocabulary improves communication between developers, end‑users, regulators and suppliers, and supports interoperability and consistent device design across sectors.

Key Topics

The document is organized around core topic groups and provides concise definitions and notes. Key topic areas include:

• General terms relevant to microfluidics: e.g., microfluidics (manipulation of fluids confined with at least one dimension smaller than 1 mm), lab‑on‑a‑chip, biocompatibility, interoperability, wettability, macroscale and microscale.
• Flow and control: vocabulary on flow behaviour and control such as volumetric flow rate, mass flow rate, hydrodynamic resistance, dead volume, swept volume, rise/ fall/ response/ settling times, transient overshoot/undershoot and micropump (capacity lower than 1 ml/min as defined in the standard).
• Interfacing and connections: terms for physical interconnects and seals including first‑level (direct) and second‑level (indirect) connections, connector, ferrule connection, LUER connector, gasket, fluidic adapter, micro‑to‑macroscale sealing and exclusion area.
• Modularity and systems: definitions covering system, component, plug‑and‑play, open and closed systems, and concepts supporting modular microfluidic design.

Applications

ISO 10991:2023 is directly applicable to practitioners and stakeholders engaged in:

• Development of diagnostic and analytical devices (lab‑on‑a‑chip, point‑of‑care tests)
• Design and testing of microfluidic pumps, valves and interconnects
• Biotech and pharmaceutical workflows that require reproducible fluid handling
• Agrifood and chemical process miniaturization efforts

Using the standardized vocabulary reduces ambiguity in specifications, test reports and procurement documents and supports regulatory submissions and supplier integration.

Related Standards

ISO 10991:2023 was prepared by ISO/TC 48 (Laboratory equipment) and cites related terminology resources and standards such as:

• ISO 5492:2008 (classification references)
• ISO 472:2013 (wettability term source)
• SEMI MS003 and SEMI E17 references used for flow and dimension terms
• ISO Online Browsing Platform and IEC Electropedia for terminology

For implementation and updates, consult the ISO Online Browsing Platform (https://www.iso.org/obp) and national standards bodies. Adopting ISO 10991 helps teams align requirements, testing and documentation across the microfluidics value chain.