Overview
ISO 14408:2016 specifies marking, labelling and accompanying information that manufacturers must supply for cuffed and uncuffed tracheal tubes and related materials designed to resist ignition by a laser. The standard focuses on clear product identification, user instructions, warnings and test-result reporting for tracheal tubes intended for laser airway surgery. It references laser-resistance test methods (ISO 11990‑1 and ISO 11990‑2) and harmonizes symbol use with ISO 7000 and ISO 15223‑1.
Key topics and requirements
- Scope and definitions - Covers laser‑resistant tracheal tubes, tube treatments, cuffs and laser‑resistant portions; defines terms such as “laser‑resistant tracheal tube”.
- Marking on the device - Permanent, legible, non‑toxic markings required (manufacturer name/trademark, nominal inside diameter, model identification). For cuffed tubes, a reference to any essential preparatory step (e.g. “inflate the cuff with saline or water before use”) must be marked.
- Identification of laser‑resistant portions - If not visually obvious, the laser‑resistant area must be marked; any marks on the laser‑resistant area are subject to laser‑resistance testing.
- Labeling of packs and containers - Pack labels must include content description, sterility status, single‑use statement (if applicable), product code, outside/inside diameters, traceability (batch/serial), storage instructions and a directive to consult laser‑resistance information.
- Information supplied by manufacturer - Clear instructions for preparation, use and maintenance (including set‑up steps for treatments), recommended cleaning/sterilization (unless single‑use), presence of natural rubber (latex), indications/contraindications including laser types and nominal wavelengths, and warnings about damage modes other than ignition.
- Test reporting - A graphical presentation of laser‑resistance test results (per ISO 11990‑1/2) must be provided for each laser type deemed appropriate by the manufacturer.
- Symbol use and normative references - Encourages standardized symbols per ISO 7000 and ISO 15223‑1; references EN 1041 for markings on packaging and inserts.
Applications and users
ISO 14408:2016 is used by:
- Medical device manufacturers - to design compliant labels, markings and instructions for laser‑resistant tracheal tubes and treatments.
- Regulatory and compliance teams - to verify conformity with labeling and information requirements.
- Testing laboratories - when reporting laser resistance per ISO 11990 series and producing the required graphs.
- Hospitals and procurement specialists - to assess safe selection, storage and use of laser‑resistant airway devices.
- Operating room clinicians and OR nurses - to follow required preparatory steps and warnings during laser airway procedures.
Related standards
- ISO 11990‑1 / ISO 11990‑2 - laser resistance test methods for tracheal tube shafts and cuffs
- ISO 15223‑1 - symbols for medical device labelling
- ISO 7000 - graphical symbols for equipment
- EN 1041 - information supplied by the manufacturer
Keywords: ISO 14408:2016, tracheal tubes, laser surgery, laser‑resistant tracheal tube, labelling, marking, medical device standards, ISO 11990.