Overview
ISO 18190:2016 - Anaesthetic and respiratory equipment - General requirements for airways and related equipment specifies the general safety, performance, design, marking and packaging requirements that are common across airway devices. It is a central, harmonized reference intended to reduce repetition in device-specific standards. Device‑specific standards take priority over ISO 18190 where conflicts occur. The standard applies to devices that provide an interface to the patient’s airways, either by direct contact or as intermediate components to other anaesthetic and respiratory equipment.
Key topics and technical requirements
ISO 18190:2016 organizes general requirements into clear technical areas. Major topics include:
- Risk management: Requires systematic risk analysis, assessment and documentation in line with ISO 14971 principles.
- Usability and clinical evaluation: Emphasizes human factors, user instructions and clinical evidence to support safe use (links to IEC 62366 / IEC 60601‑1‑6).
- Materials & biological safety: Calls for biological evaluation (ISO 10993), controls on leachables, phthalates, latex content and gas compatibility (ISO 15001).
- Design and mechanical safety: Covers mechanical, electrical and pneumatic safety, protection against inadvertent adjustments, device lifetime and resistance to deterioration (including MRI considerations).
- Sterility and sterilization: Requirements for sterility assurance, packaging for sterile products and validation of sterilization processes (ISO 11135, ISO 11137, ISO 11607).
- Cleaning, disinfection and reprocessing: Expectations for validated cleaning/disinfection instructions and compatibility with common agents.
- Packaging, marking and labelling: Durable marking, symbols (ISO 15223 series, ISO 7000), and comprehensive Instructions for Use to ensure traceability and safe clinical application.
- Special considerations: Prevention of electrostatic charge, radiopacity testing references and annexes that cover rationale and hazard identification for risk assessment.
Applications - who uses this standard
ISO 18190:2016 is used by:
- Medical device manufacturers of airways and related equipment to establish compliance with general safety and performance requirements.
- Regulatory bodies and conformity assessors evaluating device documentation and risk files.
- Test laboratories and notified bodies performing verification of sterility, labelling and materials testing.
- Clinical engineering, procurement and hospital safety officers relying on standard-based specifications for acquisition and safe use.
Related standards (examples)
Normative references linked in ISO 18190 include ISO 14971 (risk management), ISO 10993 (biocompatibility), ISO 11607 (sterile packaging), IEC 60601 series (electrical safety), ISO 15223 (symbols) and ISO 15001 (oxygen compatibility). ISO 18190 serves as a foundational general‑requirements catalogue that complements device‑specific standards.
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