ISO 18113-5:2022

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
  • Compliance with relevant electrical, safety and EMC labelling standards (e.g., IEC 61010‑1, IEC 61010‑2‑101, IEC 61326‑2‑6) and use of standardized symbols per ISO 15223-1.
• 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

• ISO 18113-1 (general labelling requirements)
• ISO 15223-1 (symbols for medical device labelling)
• ISO 14971 (risk management)
• IEC 61010 series, IEC 61326-2-6, IEC 62366-1

Keywords: ISO 18113-5:2022, IVD instruments for self-testing, labelling requirements, instructions for use, UDI, in vitro diagnostic, medical device labelling.