DS/EN ISO 5367:2014

Anaesthetic and respiratory equipment - Breathing sets and connectors


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 96.62
Legislation:

Please note that this standard has not yet been harmonised and thus cannot be used for CE marking. Until harmonisation of this standard has been achieved, please use one of the following standards: 


Legislation

Please note that this standard has not yet been harmonised and thus cannot be used for CE marking. Until harmonisation of this standard has been achieved, please use one of the following standards: 

Links

Scope

This International Standard specifies basic requirements for antistatic and non-antistatic breathing sets, breathing tubes, and breathing tubes supplied to be cut to length, intended to be used with anaesthetic apparatus and ventilators, humidifiers and nebulizers. It also 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 manufacturers' instructions.
This International Standard is applicable to breathing sets and breathing tubes having ends incorporating adaptors with conical connectors (assembled ends) or with plain ends (either cylindrical or tapered).
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, such as those used with ventilators having special compliance, pressure, or breathing frequency requirements.
NOTE 1 – Examples of these breathing sets may include High Frequency Oscillatory Ventilation, (HFOV), or High Frequency Jet Ventilation (HFJV).
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.
NOTE 2 – Examples of various types of breathing sets with patient end adaptors are depicted in Annex A.
Requirements for exhalation valves, exhaust valves, and adjustable pressure-limiting (APL) valves and reservoir bags, if provided, are not covered by this standard.
NOTE 3 – ISO 80601-2-12, ISO 80601-2-13 and ISO 5362 cover these.
NOTE 4 – Certain aspects of heated wire breathing tubes are discussed in ISO 8185 [1].


Number of pages: 50

Published: 2014-12-18

Date of approval: 2014-11-03

International relationships : EN ISO 5367:2014 IDT ISO 5367:2014 IDT

ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment

Item number: M260965


Committees

Committee

  • CEN/TC 215
  • ISO/TC 121/SC 2
  • ISO/TC 121/SC 2

Danish committee

DS/S-104