ISO 7376-2:2025

Overview

ISO 7376-2:2025 - Anaesthetic and respiratory equipment - Part 2: Video laryngoscopes defines safety and performance requirements for electrically powered video laryngoscopes. The standard applies to systems that include a handle, a rigid blade, an integrated light source, a camera and an image display that together provide a clear view of the larynx to assist tracheal intubation. It covers essential accessories and device lifecycle considerations (cleaning, storage, batteries, instructions). It explicitly excludes laryngoscopes without a camera (see ISO 7376), endoscopes (ISO 8600‑1), surgical laryngoscopes and image quality requirements for third‑party displays not supplied as part of the system.

Key Topics and Technical Requirements

ISO 7376-2:2025 focuses on device-specific performance, testing and information requirements, including:

• General requirements & risk management aligned with ISO 14971.
• Materials and external surface considerations for patient safety and cleaning.
• Design requirements covering components, mechanical performance and durability:
  • Strength, rigidity and drop testing.
  • Illumination performance and prevention of camera lens condensation.
• Image quality specifications and testable parameters:
  • Limiting resolution, distortion, latency, contrast.
  • Image display performance and field of view (FOV) requirements.
• System communication, temperature, batteries, transportation and storage constraints.
• Cleaning, disinfection and sterilization instructions and manufacturer-supplied processing information (ISO 17664 references).
• Information for users: markings, labelling and Instructions for Use (IFU).
• Normative and informative annexes providing test methods (illumination, FOV), hazard identification and example designs.

Practical Applications and Users

ISO 7376-2:2025 is useful for:

• Manufacturers and product designers developing electrically powered video laryngoscopes to meet recognized performance and safety criteria.
• Regulatory and quality teams preparing technical files, conformity assessments and clinical evaluation for market approval.
• Test laboratories and compliance engineers executing specified mechanical and image-quality tests (annex test methods).
• Hospital procurement, clinical educators and airway management teams (anaesthesiologists, intensivists, emergency physicians, paramedics, respiratory therapists) seeking devices that conform to standardized performance and safety expectations.

Adoption of the standard promotes improved patient safety (especially for difficult intubations), consistent device performance and clear manufacturer guidance on cleaning and use.

Related Standards

Key related documents referenced by ISO 7376-2:2025:

• ISO 7376:2020 (laryngoscopes without camera)
• ISO 14971 (risk management)
• IEC 60601 series (medical electrical equipment)
• IEC 60601-2-18 (endoscopic equipment)
• ISO 18190 (general requirements for airway devices)
• ISO 17664 (processing/IFU requirements)

Keywords: ISO 7376-2:2025, video laryngoscopes, anaesthetic and respiratory equipment, image quality, field of view, medical device standard, risk management.