Overview
ISO 18113-3:2022 specifies the labelling and information requirements for in vitro diagnostic (IVD) instruments intended for professional use. It defines what manufacturers must supply with IVD instruments, apparatus, equipment and applicable accessories to ensure safe, effective use in clinical and laboratory settings. The standard complements ISO 18113-1 (general requirements) and is not applicable to instrument servicing/repair instructions, IVD reagents (including calibrators and controls), or self‑testing instruments.
Key topics and requirements
- Scope and exclusions: Applies to IVD instruments for professional use, related apparatus and some accessories; excludes servicing, reagents and self‑testing devices.
- Identification and labelling:
- IVD instrument name and any additional identifiers (catalogue or commodity numbers) when a name is not unique.
- Serial number (or batch code where serial numbering is impractical).
- Statement or symbol indicating in vitro diagnostic use when required by regulation.
- Unique Device Identifier (UDI) guidance - inclusion of UDI‑DI and UDI‑PI (with serial number or batch code) and both AIDC and human‑readable formats where regulatory rules apply.
- Instructions for use (IFU) content: Required elements include manufacturer details, full device identification (name, module/software IDs), intended use/purpose, storage/handling, warnings/precautions, installation and site preparation, theory of operation, functions and limitations, operating procedures, control procedures, calculation of results, maintenance, troubleshooting, shutdown, disposal and document control.
- Labeling standards and safety: Conformance with IEC 61010 series and IEC 61326 for labels/marking; symbol use aligned with ISO 15223‑1; risk management per ISO 14971; usability considerations per IEC 62366‑1.
- Regulatory consistency and harmonization: Designed to support IMDRF partners and jurisdictions adopting harmonized labelling rules.
Applications and users
- Who uses it:
- IVD instrument manufacturers and technical writers preparing IFUs and labels.
- Regulatory affairs and quality managers ensuring compliance with labelling requirements.
- Clinical laboratory managers and procurement teams verifying supplied documentation.
- Notified bodies and regulators assessing conformity of labelling and IFUs.
- Practical value:
- Ensures consistent, clear labelling that supports safe instrument operation and regulatory submissions.
- Reduces ambiguity in intended use, installation, operation and maintenance - improving patient safety and laboratory workflow.
- Facilitates global market access by aligning information requirements across jurisdictions.
Related standards
Keywords: ISO 18113-3:2022, IVD instruments, labelling, instructions for use, UDI, in vitro diagnostic, regulatory compliance.
Open preview (PDF)In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use
