Overview
EN ISO 14408:2016 - “Tracheal tubes designed for laser surgery - Requirements for marking and accompanying information (ISO 14408:2016)” specifies mandatory marking, labelling and manufacturer-supplied information for cuffed and uncuffed tracheal tubes and related materials that are designed to resist ignition by a laser. The standard focuses on what information must accompany laser‑resistant tracheal tubes rather than mandating specific materials or design solutions, and it aligns with regulatory requirements in the EU (see Annex ZA / Directive 93/42/EEC).
Key topics and technical requirements
- Scope and purpose: Defines required markings, pack labelling, shelf/multi-unit container labelling and the information to be supplied by the manufacturer for laser‑resistant tracheal tubes.
- Use of symbols: Mandates use of standardized graphical symbols where applicable (reference to ISO 7000 and ISO 15223-1).
- Marking on the device: Requirements include sizing and identification marks (ID/OD conventions), optional positioning marks, and marking for cuff outer diameter where applicable.
- Labelling of packs and containers: Manufacturer name/trademark, authorized representative (if applicable), sterility indication, batch/serial/year identification and limited packing labelling rules are addressed.
- Information to be supplied: Instructions for preparation and use of laser‑resistant tracheal tubes, indications for use, warnings and precautions related to laser surgery, and cleaning/sterilization guidance (within the standard’s limited scope).
- Laser resistance reporting: Requires a standardized graph/chart showing test results produced according to the normative test methods (ISO 11990‑1 for shaft and ISO 11990‑2 for cuffs).
- Regulatory alignment: Annex ZA maps clauses to the Essential Requirements of EU Directive 93/42/EEC for medical devices, providing a presumption of conformity when implemented.
Applications and practical value
- Ensures clear, consistent labeling and information for tracheal tubes intended for use in laser procedures.
- Helps hospitals, surgical teams and anaesthesia providers understand device limitations, preparation steps and laser‑related precautions.
- Supports regulatory compliance and market access in jurisdictions recognizing EN/ISO standards (notably the EU).
- Standardizes the way laser resistance test results are reported so clinicians and procurement teams can compare products reliably.
Who uses this standard
- Medical device manufacturers and designers of tracheal tubes for laser surgery
- Test laboratories performing ISO 11990 series laser‑resistance testing
- Regulatory and quality assurance teams assessing device labeling and instructions
- Hospital procurement, anaesthetists and surgical teams evaluating products for laser procedures
Related standards
