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BS EN ISO 5367:2014

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by

Anaesthetic and respiratory equipment. Breathing sets and connectors

Available format(s)

Hardcopy , PDF

Superseded date

26-07-2023

Superseded by

BS EN ISO 5367:2023

Language(s)

English

Published date

31-12-2014

€306.17
Excluding VAT

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.

Committee
CH/121/5
DevelopmentNote
Supersedes BS EN 12342 & 12/30210881 DC. (11/2014)
DocumentType
Standard
Pages
48
ProductNote
This standard is identical to EN ISO 5367 : 2014
PublisherName
British Standards Institution
Status
Superseded
SupersededBy
Supersedes

*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].

Standards Relationship
EN ISO 5367:2014 Identical
ISO 5367:2014 Identical

ISO 80601-2-13:2011 Medical electrical equipment Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation
IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-6:2010+AMD1:2013 CSV Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
ISO 5356-1:2015 Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets
IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
ISO 10414-2:2011 Petroleum and natural gas industries Field testing of drilling fluids Part 2: Oil-based fluids
ISO 80601-2-12:2011 Medical electrical equipment Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
ISO 5362:2006 Anaesthetic reservoir bags
ISO 15403:2000 Natural gas Designation of the quality of natural gas for use as a compressed fuel for vehicles
EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
ISO 8185:2007 Respiratory tract humidifiers for medical use Particular requirements for respiratory humidification systems
ISO 23328-2:2002 Breathing system filters for anaesthetic and respiratory use — Part 2: Non-filtration aspects
ISO 6142:2001 Gas analysis Preparation of calibration gas mixtures Gravimetric method
ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO/IEC Guide 21-1:2005 Regional or national adoption of International Standards and other International Deliverables — Part 1: Adoption of International Standards
ISO 9360-1:2000 Anaesthetic and respiratory equipment — Heat and moisture exchangers (HMEs) for humidifying respired gases in humans — Part 1: HMEs for use with minimum tidal volumes of 250 ml
ISO 14971:2007 Medical devices Application of risk management to medical devices
ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 4135:2001 Anaesthetic and respiratory equipment Vocabulary
ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements

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