ISO 18190-2025 PDF

Full title and description

ISO 18190:2025 — Anaesthetic and respiratory equipment — General requirements for airway devices and related equipment. This second-edition International Standard specifies general, cross‑cutting requirements that apply to airway devices and related equipment used in anaesthesia and respiratory care.

Abstract

This document sets out the general requirements common to airway devices and related equipment. It is intended to be referenced by device‑specific standards; where a device‑specific standard exists, its requirements take priority over the general requirements in ISO 18190:2025.

General information

• Status: Published.
• Publication date: 12 February 2025 (edition 2, published February 2025).
• Publisher: International Organization for Standardization (ISO), prepared by ISO/TC 121/SC 2.
• ICS / categories: 11.040.10 (Anaesthetic, respiratory and resuscitation equipment).
• Edition / version: Edition 2 (2025). Revises and replaces ISO 18190:2016.
• Number of pages: Retail metadata commonly lists 16 pages for the ISO 18190:2025 PDF; some aggregated sellers/show listings report different page counts (e.g., 67 pages for a tracked‑changes or national adoption document). Purchasers should confirm page count with their national standards body or the ISO product listing.

Scope

ISO 18190:2025 specifies the general requirements common to airway devices and related equipment used in anaesthetic and respiratory care. The scope covers general design, safety and information requirements that are applicable across device‑specific standards for airways and related products. Device‑specific standards take precedence where they exist.

Key topics and requirements

• General safety and performance principles applicable to airway devices and related equipment.
• Requirements for identification, marking and labelling to ensure safe use and traceability.
• Design and materials considerations relevant to breathing gas pathways (including attention to biocompatibility where applicable, cross‑referencing biocompatibility standards).
• Information for use (instructions, warnings and essential performance information) to be provided by the manufacturer.
• Interoperability and connector compatibility considerations (cross‑references to small‑bore connector standards where relevant).

Typical use and users

Primary users are manufacturers and designers of airway and related anaesthetic/respiratory devices, conformity assessment bodies, clinical engineering and hospital procurement teams, regulatory authorities, and testing laboratories. The standard is used to inform product technical files, design controls and labeling for airway‑related medical devices.

Related standards

Standards commonly referenced alongside ISO 18190:2025 include ISO 18562 (biocompatibility evaluation of breathing gas pathways), ISO 80369 (small‑bore connectors for liquids and gases in healthcare), ISO 23372 (air entrainment devices), ISO 27427 (nebulizing systems), and relevant parts of ISO 80601 series for medical electrical equipment. Users should consult device‑specific standards for additional requirements.

Keywords

airway devices; anaesthetic equipment; respiratory equipment; general requirements; labelling; biocompatibility; breathing gas pathway; ISO/TC 121/SC 2.

FAQ

Q: What is this standard?

A: ISO 18190:2025 is the second edition of an ISO International Standard that defines general requirements common to airway devices and related anaesthetic/respiratory equipment.

Q: What does it cover?

A: It covers cross‑cutting requirements such as safety and performance principles, marking/labeling, information for use, and material/design considerations for airway devices; device‑specific standards take precedence for detailed requirements.

Q: Who typically uses it?

A: Device manufacturers, regulatory and conformity assessment bodies, clinical engineers, testing laboratories and procurement teams use ISO 18190:2025 to guide design, documentation and compliance activities for airway‑related devices.

Q: Is it current or superseded?

A: Current — ISO 18190:2025 (edition 2, published February 2025) is the active standard and supersedes ISO 18190:2016.

Q: Is it part of a series?

A: It is a general‑requirements standard within the anaesthetic and respiratory equipment family managed by ISO/TC 121/SC 2 and is commonly cross‑referenced by device‑specific standards (for example standards addressing nebulizers, connectors, breathing circuits and biocompatibility).

Q: What are the key keywords?

A: Airway, airway devices, anaesthetic equipment, respiratory equipment, general requirements, labelling, breathing gas pathway, biocompatibility.