Overview
EN ISO 10991:2023 / ISO 10991:2023 - Microfluidics - Vocabulary defines standard terms and definitions used in micro process engineering and microfluidics. This second edition (approved September 2023) supersedes the 2009 edition and was prepared by ISO/TC 48 in collaboration with CEN/TC 332. The scope covers microfluidics applied in medical and veterinary diagnostics, chemistry, agriculture, pharmacy, biotechnology and the agrifood industry, and other application areas. EN ISO 10991:2023 is adopted across CEN member bodies as a harmonized European standard.
Key topics and technical terms
This document is a vocabulary standard - it does not set test methods but provides consistent terminology to support design, documentation and regulation. Major topic groups include:
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General microfluidics terms
- microfluidics, microscale, macroscale, miniaturization, lab-on-a-chip (LoC), system, end-user, interested party
- material/interface attributes: biocompatibility, hydrophilic / hydrophobic, wettability, biomarker
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Flow and performance terms
- flow rate, actual flow rate, mass flow rate, capacity, micropump
- dead volume, hold-up volume, internal volume, compliance, hydrodynamic resistance, hydrostatic pressure, pressure drop
- dynamic response concepts: rise time, fall time, response time, reaction time, settling time, relative flow stability
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Microfluidic modalities & architectures
- centrifugal microfluidics, digital microfluidics, droplet microfluidics, lab-on-a-chip
- open vs closed systems, plug-and-play, interoperability, modularity
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Measurement and control
- resolution, sensing resolution, actuating resolution, set point
The standard cites established sources for some definitions (e.g., ISO 5492, ISO 9000, SEMI documents) and explicitly contains no normative references.
Practical applications - who uses it and why
EN ISO 10991:2023 is intended for:
- Manufacturers and designers of microfluidic devices and lab-on-a-chip systems - for clear product specifications and datasheets.
- Test laboratories and quality teams - to harmonize measurement language (flow rates, dead volume, response times).
- Regulatory and procurement professionals - to ensure consistent terminology in submissions and contracts.
- Researchers and integrators - to enable interoperability and clear communication across multidisciplinary teams (chemistry, biotech, diagnostics, agrifood).
- Standards committees and technical writers - as the authoritative vocabulary for subsequent standards and guidance documents.
Practical uses include writing technical specifications, system interoperability requirements, test protocols descriptions, user manuals, and regulatory dossiers.
Related standards
- ISO 10991:2023 was prepared by ISO/TC 48 and endorsed as EN ISO 10991:2023 by CEN.
- The vocabulary draws on and cross-references existing terminology standards such as ISO 5492 and ISO 9000 and semiconductor/industry glossaries (SEMI). Note: the document itself states there are no normative references.
Keywords: ISO 10991:2023, EN ISO 10991, microfluidics vocabulary, lab-on-a-chip terms, micro process engineering terminology, hydrodynamic resistance, dead volume, micropump.
