SIST EN ISO 18113-1:2024 PDF

Overview

EN ISO 18113-1:2024 (identical to ISO 18113-1:2022) is the harmonized European adoption of an international standard that defines terms, concepts and general requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) medical devices. It sets the foundational vocabulary and high‑level principles used across the EN ISO 18113 labelling series and supports manufacturer labelling, instructions for use (IFU) and technical documentation for IVDs. The standard explicitly excludes language requirements (left to national/regional law) and does not apply to: IVDs for performance evaluation (investigational use), shipping documents, material safety data sheets / SDS, or marketing materials.

Key topics and requirements

The standard focuses on definitions and general labelling principles, including:

• Terms and definitions for IVD devices and performance characteristics (core vocabulary for manufacturers, regulators and test labs).
• General requirements for information supplied by the manufacturer, including scope and structure of IFUs.
• Language, symbols and identification colours - guidance on use of symbols and colour coding (note: specific language obligations are outside the standard).
• Values and nomenclature - how to present numeric results, units and nomenclature consistently.
• Microbiological state - labelling related to sterile/non‑sterile product state.
• Instructions for use (IFU) - content and presentation principles for safe and effective use.
• Change management - communicating device changes that affect labelling or use.
• Disclosure of residual risks and identification of kit components.
• Assistance - instructions on how users obtain technical support or additional information.
• Informative Annex A on performance characteristics and a bibliography for further reference.

Practical applications and users

This document is essential for:

• IVD manufacturers preparing labelling, IFUs and technical documentation.
• Regulatory affairs and quality managers mapping labelling to regulatory frameworks (e.g., IVDR / Regulation (EU) 2017/746).
• Technical writers and usability engineers who author IFUs and on‑product labelling.
• Notified bodies, conformity assessors and laboratories assessing documentation and post‑market information.

Use cases:

• Drafting consistent IFUs and on‑label information for IVDs.
• Aligning labelling practices with EU IVDR expectations (see Annex ZA mapping to Regulation (EU) 2017/746).
• Integrating with ISO 13485, ISO 14971, ISO 15223‑1 and IEC 62366‑1 for comprehensive compliance.

Related standards

This part is the foundational element of the EN ISO 18113-series and is intended to be used alongside:

• ISO 13485 (QMS for medical devices)
• ISO 14971 (risk management)
• ISO 15223‑1 (symbols for medical device labelling)
• IEC 62366‑1 (usability engineering)

Keywords: EN ISO 18113-1:2024, IVD labelling standard, instructions for use (IFU), in vitro diagnostic devices, labelling requirements, IVDR, manufacturer information, performance characteristics, symbols and colours.