SIST EN ISO 22916:2023 PDF

Overview

EN ISO 22916:2022 - Microfluidic devices: Interoperability requirements for dimensions, connections and initial device classification - specifies minimum interface requirements to enable seamless integration of microfluidic components (chips, sensors, actuators, connectors). Adopted by CEN as EN ISO 22916:2022, this standard targets interoperability in the microfluidics ecosystem so devices from different suppliers can be connected, tested and deployed with reduced custom engineering effort.

Key topics

• Scope and applicability: Requirements for devices in the field of microfluidics that require microfluidic interconnections.
• Reference and terminology: Uses ISO 10991 vocabulary for consistent definitions.
• Chip topology and reference point: Guidance on chip layout, naming and a defined reference point to enable repeatable positioning and interfacing.
• Dimensional requirements: General tolerances plus specific guidance for chip thickness and outer dimensions aligned to common formats (microplate compatibility, microscope slide format, credit-card-like formats).
• Building blocks: Standardized microfluidic building-block concepts to simplify design reuse and modularity.
• Top and side connections: Specifications for port pitch, port diameter/shape, distances from edges, port nomenclature, interfacing areas and clamping zones to ensure reliable mechanical and fluidic connections.
• Application classes: Initial device classification with temperature and pressure boundary conditions that inform standardized testing (e.g., leakage, burst pressure, flow throughput) and product readiness.

Applications and users

EN ISO 22916:2022 is practical for:

• Device designers and OEMs creating microfluidic chips, cartridges and connectors - to design components that plug into existing systems.
• System integrators and instrument manufacturers who need predictable interfaces for pumps, sensors and peripheral modules.
• Research labs and academia seeking to swap or combine chips from multiple sources without redesigning fixtures.
• Test laboratories and quality teams using the application-class boundaries to develop cross‑technology tests and validation protocols.
• Regulatory and procurement teams evaluating interoperability and second‑source availability.

Adoption of this standard reduces custom tooling, accelerates prototyping, and simplifies scale-up and manufacturing transitions.

Related standards

• ISO 10991 - Micro process engineering - Vocabulary (normative reference for terms).
• IWA 23:2016 - Earlier guidance that has been technically revised and integrated into ISO 22916:2022.

Keywords: EN ISO 22916:2022, microfluidic devices, interoperability, microfluidic chips, connectors, device classification, microfluidics standard.