BS EN ISO 5367:2014

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Specific requirements
6 Prevention of electrostatic charges
7 Requirements for breathing sets and
  breathing tubes supplied sterile
8 Marking
Annex A (informative) - Rationale
Annex B (informative) - Hazard identification
        for risk assessment
Annex C (normative) - Test for security of
        attachment of plain end to conical connector
Annex D (normative) - Test for security of
        attachment of adaptor to breathing tube
Annex E (normative) - Test for leakage
Annex F (normative) - Measurement of resistance
        to flow
Annex G (normative) - Test for increase in flow
        resistance with bending
Annex H (normative) - Test for compliance
Bibliography
Annex ZA (informative) - Relationship between this
         European Standard and the Essential
         Requirements of EU Directive 93/42/EEC

Defines basic requirements for breathing sets and breathing tubes intended to be used with anaesthetic breathing systems, ventilator breathing systems, humidifiers or nebulizers.

*This International Standard specifies basic requirements for breathing sets and breathing tubes intended to be used with anaesthetic breathing systems, ventilator breathing systems, humidifiers or nebulizers. It applies to breathing sets and breathing tubes and patient end adaptors supplied already assembled and to those supplied as components and assembled in accordance with the manufacturer’s instructions.

This International Standard is applicable to breathing sets which include special components (e.g. water traps) between the patient end and machine end which are supplied already assembled.

This International Standard is not applicable to breathing sets and breathing tubes for special purposes.

EXAMPLE1 Ventilators having special compliance, pressure or breathing frequency requirements.

EXAMPLE2 High Frequency Oscillatory Ventilation, (HFOV) or High Frequency Jet Ventilation (HFJV).

EXAMPLE3 Breathing sets and breathing tubes with special connectors for neonatal ventilation.

Provision is made for coaxial and related bifurcated, double-lumen, or multiple-lumen breathing sets and breathing tubes suitable for use with patient end adaptors.

NOTE1 Examples of various types of breathing sets with patient end adaptors are depicted in AnnexA.

Requirements for exhalation valves, exhaust valves, adjustable pressure-limiting (APL) valves, heat and moisture exchangers (HMEs), breathing filters, and reservoir bags, if provided, are not covered by this International Standard.

NOTE2 ISO80601-2-12, ISO80601-2-13, ISO9360-1^[3], ISO23328-2^[4], and ISO5362^[1] cover these.

NOTE3 Certain aspects of heated-wire breathing tubes are discussed in ISO8185^[2].