Overview
ISO 18190:2025 - Anaesthetic and respiratory equipment - General requirements for airway devices and related equipment - is the second edition international standard that defines general safety and performance requirements common to airway devices and related equipment. It consolidates requirements for design, materials, packaging, marking and labelling so that device‑specific standards can focus on their unique safety needs. Where no device‑specific standard exists, ISO 18190:2025 can be used as the primary reference.
Key Topics and Requirements
The standard sets out high‑level, practical requirements and processes that manufacturers and regulators rely on:
- Risk management: Mandated use of a formal risk management process (aligned with ISO 14971) for design and lifecycle decisions.
- Clinical evaluation and investigations: Definitions and requirements for clinical evaluation and clinical investigations to demonstrate safety and performance.
- Materials and biocompatibility: Requirements for material selection, biological evaluation (including breathing gas pathways, referencing ISO 18562) and management of materials of concern.
- Environmental impact: Encourages manufacturers to consider environmental effects of device materials and packaging over the product lifetime.
- Design safety: Mechanical and electrical safety expectations, electrostatic charge prevention, expected device lifetime, shelf life, and transport/storage conditions.
- MR environment safety: Devices must be identified if they are safe, conditionally safe, or unsafe in magnetic resonance environments.
- Cleaning, disinfection and sterilization: Consolidated clause covering cleanliness, disinfection and sterility assurance, plus sterile packaging requirements.
- Interoperability and compatibility: Requirements for gas compatibility (e.g., oxygen compatibility) and interoperability with related equipment.
- Information and labelling: Manufacturer information requirements (marking, instructions for use) reference ISO 20417 and ISO 15223‑1 for symbols and required content.
Applications and Who Uses It
ISO 18190:2025 is intended for:
- Manufacturers of airway devices and related anaesthetic / respiratory equipment for product design, risk analysis and labelling.
- Regulatory and quality teams preparing technical files, clinical evaluations and conformity assessment documentation.
- Test and certification bodies that assess general safety, biocompatibility and sterilization processes.
- Procurement and biomedical engineers who specify requirements for hospital use, storage, cleaning and MR safety.
- Clinical researchers designing clinical investigations that support device performance claims.
Related Standards
Key normative references include:
Keywords: ISO 18190:2025, airway devices, anaesthetic and respiratory equipment, general requirements, clinical evaluation, risk management, biocompatibility, sterilization, MR safety, device labelling.
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