Overview
ISO 18113-5:2022 - part of the ISO 18113 series - specifies requirements for information supplied by the manufacturer (labelling) for in vitro diagnostic (IVD) instruments intended for self-testing. Published in 2022 (second edition), it covers labels, marking and the content and structure of instructions for use (IFU) for self-test instruments, associated apparatus/equipment and applicable accessories. It does not apply to instrument servicing/repair instructions, IVD reagents (including calibrators/control materials), or IVD instruments intended for professional use.
Key topics and requirements
The standard focuses on clear, risk‑based labelling and user information to ensure safe and effective self-testing. Key technical topics include:
- Identification and traceability
- Instrument name/trade name, additional identifiers (catalogue numbers), unique serial numbers or batch codes, and Unique Device Identifier (UDI) requirements (UDI-DI and UDI-PI including serial/batch).
- Labels and marking
- Instructions for use (IFU) content elements:
- Manufacturer identification, intended use/purpose, storage/handling, warnings/precautions, installation and commissioning, measurement principles, instrument performance and limitations, preparation and operating procedures, control procedures, reading results, special functions, shut-down, maintenance, troubleshooting, disposal and document control.
- Risk and usability considerations
- Alignment with ISO 14971 (risk management) and IEC/ISO usability guidance (e.g., IEC 62366‑1) to reduce user error in self-testing scenarios.
- Regulatory alignment
- Guidance to harmonize labelling expectations across jurisdictions and support IMDRF convergence.
Applications and who uses it
ISO 18113-5:2022 is practical for:
- IVD manufacturers designing or marketing instruments for self-testing (home use) to prepare compliant labelling and IFUs.
- Regulatory affairs and quality teams ensuring conformity with labelling requirements and UDI obligations.
- Technical writers and usability engineers developing user-friendly IFUs that meet risk-management and accessibility needs.
- Notified bodies, conformity assessors and regulators reviewing documentation for market approval.
- Distributors and healthcare providers verifying product information for safe consumer use.
Using this standard helps manufacturers reduce user errors, meet global labelling expectations, and speed regulatory review for consumer-facing IVD instruments.
Related standards
Keywords: ISO 18113-5:2022, IVD instruments for self-testing, labelling requirements, instructions for use, UDI, in vitro diagnostic, medical device labelling.