EN ISO 5361:2016

European foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements for tracheal tubes and
  tracheal tube connectors
5 Specific requirements for tracheal tubes and
  tracheal tube connectors
6 Additional requirement for tracheal tubes
  with a Murphy eye
7 Requirements for tracheal tubes with tracheal
  tube connectors supplied sterile
8 Marking
Annex A (informative) - Rationale
Annex B (normative) - Determination of cuff
        diameter
Annex C (normative) - Test method for cuffed
        tube collapse
Annex D (normative) - Test method for cuff
        herniation
Annex E (informative) - Guidance on design of
        tracheal tube connectors
Annex F (informative) - Hazard identification
        for risk assessment
Annex G (normative) - Test method for tracheal
        seal
Annex H (normative) - Test method to determine
        kink resistance
Bibliography
Annex ZA (informative) - Relationship between this
         European Standard and the Essential
Requirements of EU Directive 93/42/EEC

ISO 5361:2016 provides essential performance and safety requirements for oro-tracheal and naso-tracheal tubes and tracheal tube connectors. Tracheal tubes with walls reinforced with metal or nylon, tracheal tubes with shoulders, tapered tracheal tubes, tracheal tubes with means for suctioning, monitoring or delivery of drugs or other gases, and the many other types of tracheal tubes devised for specialized applications are included in this International Standard, as many specialized tracheal tubes are now commonly used, and all share similar essential requirements as defined in this International Standard.Endobronchial (including tracheobronchial) tubes, tracheostomy tubes, and supralaryngeal airways are excluded from the scope of ISO 5361:2016.Tracheal tubes intended for use with flammable anaesthetic gases or agents, lasers, or electrosurgical equipment are outside the scope of ISO 5361:2016.