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.

Overview

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.

ISO 18113-5:2022 PDF

Технические детали

Abstract

Overview

Key topics and requirements

Applications and who uses it

Related standards

Похожие стандарты

Abstract

Overview

Key topics and requirements

Applications and who uses it

Related standards

Похожие стандарты

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