BS EN ISO 5367:2014
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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
Hardcopy , PDF
26-07-2023
English
31-12-2014
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.
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Superseded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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