SIST EN ISO 5367:2015

SLOVENSKI STANDARD
oSIST prEN ISO 5367:2012
01-junij-2012
$QHVWH]LMVNDLQGLKDOQDRSUHPD'LKDOQLVHWLLQSULNOMXþNL,62',6
Anaesthetic and respiratory equipment - Breathing sets and connectors (ISO/DIS
5367:2012)
Anästhesie- und Beatmungsgeräte - Atemsets und Verbindungsstücke (ISO/DIS
5367:2012)
Matériel d'anesthésie et de réanimation respiratoire - Circuits respiratoires et de
connecteurs (ISO/DIS 5367:2012)
Ta slovenski standard je istoveten z: prEN ISO 5367
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
oSIST prEN ISO 5367:2012 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
oSIST prEN ISO 5367:2012

---------------------- Page: 2 ----------------------
oSIST prEN ISO 5367:2012


EUROPEAN STANDARD
DRAFT
prEN ISO 5367
NORME EUROPÉENNE

EUROPÄISCHE NORM

February 2012
ICS 11.040.10
English Version
Anaesthetic and respiratory equipment - Breathing sets and
connectors (ISO/DIS 5367:2012)
Matériel d'anesthésie et de réanimation respiratoire - Anästhesie- und Beatmungsgeräte - Atemsets und
Circuits respiratoires et de connecteurs (ISO/DIS Verbindungsstücke (ISO/DIS 5367:2012)
5367:2012)
This draft European Standard is submitted to CEN members for parallel enquiry. It has been drawn up by the Technical Committee
CEN/TC 215.

If this draft becomes a European Standard, CEN members are bound to comply with the CEN/CENELEC Internal Regulations which
stipulate the conditions for giving this European Standard the status of a national standard without any alteration.

This draft European Standard was established by CEN in three official versions (English, French, German). A version in any other language
made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.

Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are aware and to
provide supporting documentation.

Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.


EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2012 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN ISO 5367:2012: E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------
oSIST prEN ISO 5367:2012
prEN ISO 5367:2012 (E)
Contents Page
Foreword .3

2

---------------------- Page: 4 ----------------------
oSIST prEN ISO 5367:2012
prEN ISO 5367:2012 (E)
Foreword
This document (prEN ISO 5367:2012) has been prepared by Technical Committee ISO/TC 121 "Anaesthetic
and respiratory equipment" in collaboration with Technical Committee CEN/TC 215 “Respiratory and
anaesthetic equipment” the secretariat of which is held by BSI.
This document is currently submitted to the parallel Enquiry.
Endorsement notice
The text of ISO/DIS 5367:2012 has been approved by CEN as a prEN ISO 5367:2012 without any
modification.

3

---------------------- Page: 5 ----------------------
oSIST prEN ISO 5367:2012

---------------------- Page: 6 ----------------------
oSIST prEN ISO 5367:2012

DRAFT INTERNATIONAL STANDARD ISO/DIS 5367
ISO/TC 121/SC 2 Secretariat: ANSI
Voting begins on Voting terminates on

2012-02-23 2012-07-23
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION  •  МЕЖДУНАРОДНАЯ ОРГАНИЗАЦИЯ ПО СТАНДАРТИЗАЦИИ  •  ORGANISATION INTERNATIONALE DE NORMALISATION


Anaesthetic and respiratory equipment — Breathing sets and
connectors
Matériel d'anesthésie et de réanimation respiratoire — Circuits respiratoires et de connecteurs
[Revision of fourth edition (ISO 5367:2000)]
ICS 11.040.10




ISO/CEN PARALLEL PROCESSING
This draft has been developed within the International Organization for Standardization (ISO), and
processed under the ISO-lead mode of collaboration as defined in the Vienna Agreement.
This draft is hereby submitted to the ISO member bodies and to the CEN member bodies for a parallel
five-month enquiry.
Should this draft be accepted, a final draft, established on the basis of comments received, will be
submitted to a parallel two-month approval vote in ISO and formal vote in CEN.

In accordance with the provisions of Council Resolution 15/1993 this document is circulated in
the English language only.
Conformément aux dispositions de la Résolution du Conseil 15/1993, ce document est
distribué en version anglaise seulement.

To expedite distribution, this document is circulated as received from the committee
secretariat. ISO Central Secretariat work of editing and text composition will be undertaken at
publication stage.
Pour accélérer la distribution, le présent document est distribué tel qu'il est parvenu du
secrétariat du comité. Le travail de rédaction et de composition de texte sera effectué au
Secrétariat central de l'ISO au stade de publication.



THIS DOCUMENT IS A DRAFT CIRCULATED FOR COMMENT AND APPROVAL. IT IS THEREFORE SUBJECT TO CHANGE AND MAY NOT BE
REFERRED TO AS AN INTERNATIONAL STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS BEING ACCEPTABLE FOR INDUSTRIAL, TECHNOLOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN NATIONAL REGULATIONS.
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT, WITH THEIR COMMENTS, NOTIFICATION OF ANY RELEVANT PATENT RIGHTS OF WHICH
THEY ARE AWARE AND TO PROVIDE SUPPORTING DOCUMENTATION.
©  International Organization for Standardization, 2012

---------------------- Page: 7 ----------------------
oSIST prEN ISO 5367:2012
ISO/DIS 5367

Copyright notice
This ISO document is a Draft International Standard and is copyright-protected by ISO. Except as permitted
under the applicable laws of the user’s country, neither this ISO draft nor any extract from it may be
reproduced, stored in a retrieval system or transmitted in any form or by any means, electronic,
photocopying, recording or otherwise, without prior written permission being secured.
Requests for permission to reproduce should be addressed to either ISO at the address below or ISO’s
member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Reproduction may be subject to royalty payments or a licensing agreement.
Violators may be prosecuted.

ii © ISO 2012 – All rights reserved

---------------------- Page: 8 ----------------------
oSIST prEN ISO 5367:2012
ISO/DIS 5367

Contents Page
Foreword . v
Introduction . vi
1 Scope . 1
2 1BNormative references . 1
3 Terms and definitions . 2
4 3BGeneral requirements . 4
4.1 8BRisk management . 4
4.2 Usability . 5
4.3 Clinical evaluation . 5
4.4 Biophysical or modelling research . 5
4.5 9BTest Methods . 5
4.6 10BRecommended service life . 5
5 Specific requirements . 5
5.1 11BMaterials . 5
5.2 14BLength . 6
5.3 Means of connection . 6
5.4 17BLeakage . 7
5.5 18BResistance to flow . 8
5.6 19BCompliance . 9
6 4BPrevention of electrostatic charges . 9
7 5BRequirements for breathing sets and breathing tubes supplied sterile . 10
7.1 20BSterility assurance . 10
7.2 21BPackaging of breathing sets and breathing tubes supplied sterile . 10
8 6BMarking . 10
8.1 22BGeneral . 10
8.2 23BMarking of breathing sets and breathing tubes . 10
8.3 24BMarking of packages . 10
8.4 Information to be supplied by the manufacturer . 12
Annex A (informative) Rationale . 13
Annex B (informative) Hazard identification for risk assessment . 20
Annex C (normative) Test for security of attachment of plain end to conical connector . 21
Annex D (normative) Test for security of attachment of adaptor to breathing tube . 22
Annex E (normative) Test for leakage . 23
Annex F (normative) Measurement of resistance to flow . 25
Annex G (normative) Test for increase in flow resistance with bending . 28
Annex H (normative) Test for compliance . 30
Bibliography . 32
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC . 33


© ISO 2011 – All rights reserved iii

---------------------- Page: 9 ----------------------
oSIST prEN ISO 5367:2012
ISO/DIS 5367

Figures
Figure 1 — Axial length of plain end of breathing tube . 7
Figure A.1 — Example of a basic anaesthesia breathing set . 13
Figure A.2 — Example of a basic coaxial anaesthesia breathing set (i.e. Mapleson D-Bain) . 13
Figure A.3 — Example of a basic single tube breathing set with exhalation valve . 14
Figure A.4 — Example of a critical care ventilator breathing set with water traps and connections to a
humidifier (H) and ventilator (V) . 14
Figure A.5 — Example of a multiple lumen coaxial breathing set with gas sampling tubing . 15
Figure A.6 — VBS leakage limits by breathing system standard . 16
Figure A.7 — VBS leakage limits evaluated at the new pressure level . 17
Figure F.1 — Typical apparatus for measuring resistance to air flow . 26

Tables
*Table 1 — Leakage limit by patient category . 8
*Table 2 —Flow resistance limit by patient category . 8
Table 3 — Compliance limit per metre by intended delivered volume . 9
Table 4 — Compliance limit by intended delivered volume . 9
Table 5 — Patient categories . 12
Table F.1 — Test Flow Rates . 27
Table G.1 Test flow for flow resistance to bending . 28
Table ZA 1 — Correspondence between this European Document and Directive 93/42/EEC . 33

iv © ISO 2011 – All rights reserved

---------------------- Page: 10 ----------------------
oSIST prEN ISO 5367:2012
ISO/DIS 5367

1 Foreword
2 ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
3 (ISO member bodies). The work of preparing International Standards is normally carried out through ISO
4 technical committees. Each member body interested in a subject for which a technical committee has been
5 established has the right to be represented on that committee. International organizations, governmental and
6 non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
7 International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
8 International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
9 The main task of technical committees is to prepare International Standards. Draft International Standards
10 adopted by the technical committees are circulated to the member bodies for voting. Publication as an
11 International Standard requires approval by at least 75 % of the member bodies casting a vote.
12 Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
13 rights. ISO shall not be held responsible for identifying any or all such patent rights.
14 ISO 5367 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment,
15 Subcommittee SC 2, Airways and related equipment, Working Group (WG 3) which consisted of experts from
16 ISO/TC 121 subcommittees SC 1, SC 2, and SC 3.
17 This fifth edition cancels and replaces the fourth edition (ISO 5367:2000), which has been technically revised.
18 The following major changes were made:
19 - title and scope;
20 - additional normative references;
21 - additional terms and definitions;
22 - additional general requirements, including risk management, usability, clinical and biophysical research;
23 - requirements for coaxial tubing, revised leakage limits, and testing for flow resistance and compliance;
24 - revised limits for prevention of electrostatic charges;
25 - revised requirements for marking of packaging, including use of symbols, disclosure of intended patient
26 category, flow resistance, and compliance;
27 - added an annex for a rationale;
28 - added annex for hazard identification for risk assessment;
29 - revised test method annexes for resistance to flow, security of attachments, leakage, and compliance;
30 - added annex for compliance with the EU Directives.
31
32
© ISO 2011 – All rights reserved v

---------------------- Page: 11 ----------------------
oSIST prEN ISO 5367:2012
ISO/DIS 5367

33 Introduction
34 This International Standard contains requirements for breathing sets, breathing tubes, and connectors that are
35 intended to function as accessories to anaesthetic and respiratory equipment. Breathing sets and breathing
36 tubes are characterized by certain design requirements such as a means of connection and leakage limits.
37 Disclosure requirements for compliance and flow resistance values and labelling allow the user to make an
38 informed choice when connecting these accessories to a breathing system. These design requirements are
39 intended to allow operation within the limits of system performance of the anaesthetic breathing systems and
40 ventilator breathing systems with which the accessories are intended to operate.
41 This International Standard includes requirements for both single-use and reusable breathing sets and
42 breathing tubes. Re-usable breathing sets and breathing tubes are intended to comply with the requirements
43 of this International Standard for the recommended service life.
44 Certain tests are performed under constant pressure to simplify the test methodology. It is recognized that this
45 does not reflect clinical use, where pressure is intermittent and peak pressures occur for short periods. The limits
46 in the test methods take this into account. Whilst such test methods do not address product variability, the limits
47 required also take this into account.
48 Terms defined in this document are set in bold type.
49 Throughout this standard, text for which a rationale is provided in Annex A is indicated by an asterisk (*).
50 Throughout this standard, all pressures are denoted in SI units of hPa with corresponding cmH O equivalent
2
51 values rounded to the nearest whole cmH O.
2
52 NOTE The unit cmH O is not in SI notation and is not allowed in ISO documents; rounded cmH O values are given
2 2
53 for information only to allow comparison to medical literature and related breathing system standards.
54
55
vi © ISO 2011 – All rights reserved

---------------------- Page: 12 ----------------------
oSIST prEN ISO 5367:2012

DRAFT INTERNATIONAL STANDARD ISO/DIS 5367

56 Anaesthetic and respiratory equipment — Breathing sets and
57 connectors
58 1 Scope
59 * This International Standard specifies basic requirements for antistatic and non-antistatic breathing sets,
60 breathing tubes, and breathing tubes supplied to be cut to length, intended to be used with anaesthetic
61 apparatus and ventilators, humidifiers and nebulizers. It also applies to breathing sets and breathing tubes and
62 patient end adaptors supplied already assembled and to those supplied as components and assembled in
63 accordance with the manufacturers' instructions.
64 This International Standard is applicable to breathing sets and breathing tubes having ends incorporating
65 adaptors with conical connectors (assembled ends) or with plain ends (either cylindrical or tapered).
66 This International Standard is applicable to breathing sets which include special components (e.g. water traps)
67 between the patient end and machine end which are supplied already assembled.
68 This International Standard is not applicable to breathing sets and breathing tubes for special purposes, such
69 as those used with ventilators having special compliance, pressure, or breathing frequency requirements.
70 NOTE 1 Examples of these breathing sets may include High Frequency Oscillatory Ventilation, (HFOV), or High
71 Frequency Jet Ventilation (HFJV).
72 Provision is made for coaxial and related bifurcated, double lumen, or multiple lumen breathing sets and
73 breathing tubes suitable for use with patient end adaptors.
74 NOTE 2 Examples of various types of breathing sets with patient end adaptors are depicted in Annex A.
75 Requirements for exhalation valves, exhaust valves, and adjustable pressure-limiting (APL) valves and
76 reservoir bags, if provided, are not covered by this standard.
77 NOTE 3 ISO 80601-2-12, ISO 80601-2-13 and ISO 5362 cover these.
[1]
78 NOTE 4 Certain aspects of heated wire breathing tubes are discussed in ISO 8185 .
79 2 1BNormative references
80 The following referenced documents are indispensable for the application of this document. For dated
81 references, only the edition cited applies. For undated references, the latest edition of the referenced
82 document (including any amendments) applies.
83 ISO 5356-1, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets.
84 ISO 7000, Graphical symbols for use on equipment — Index and synopsis
85 ISO 10993-1, Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk
86 management process
© ISO 2011 – All rights reserved
1

---------------------- Page: 13 ----------------------
oSIST prEN ISO 5367:2012
ISO/DIS 5367

87 ISO 11607-1, Packaging for terminally sterilized medical devices -- Part 1: Requirements for materials, sterile
88 barrier systems and packaging systems
89 ISO 14971, Medical devices – Application of risk management to medical devices.
90 ISO 15223-1, Medical devices — Symbols to be used with medical device labels, labelling and information to
91 be supplied — Part 1: General requirements
92 IEC 60417, Graphical symbols for use on equipment
93 IEC 60601-1, Medical electrical equipment — Part 1: General requirements for safety.
94 IEC 60601-1-6, Medical electrical equipment – Part 1-6: General requirements for basic safety and essential
95 performance – Collateral Standard: Usability
96 IEC 62366, Medical devices – Application of usability engineering to medical devices
97 ISO 80601-2-12, Medical Electrical Equipment — Part 2-12: Particular requirements for basic safety and
98 essential performance of critical care ventilators
99 ISO 80601-2-13, Medical electrical equipment — Part 2-13: Particular requirements for basic safety and
100 essential performance of an anaesthetic workstation
101 EN 556-1, Sterilization of medical devices. Requirements for medical devices to be designated "STERILE".
102 Requirements for terminally sterilized medical devices
103 EN 980, Symbols for use in the labelling of medical devices
104 EN 1041, Information supplied by the manufacturer with medical devices
105 3 Terms and definitions
106 For the purposes of this International Standard, the following terms and definitions apply.
107 3.1
108 accessory
109 additional part for use with equipment in order to:
110 – achieve the INTENDED USE,
111 – adapt it to some special use,
112 – facilitate its use,
113 – enhance its performance, or
114 – enable its functions to be integrated with those of other equipment
115 [IEC 60601-1]
116 3.2
117 adaptor
118 specialized connector to establish functional continuity between otherwise disparate or incompatible components,
119 one end of which is intended to be inserted into the end of a breathing tube, the other end having a conical
120 connector complying with ISO 5356-1
[2]
121 [Adapted from ISO 4135 ]
122 3.3
123 anaesthetic breathing system
124 inspiratory and expiratory gas pathways through which anaesthetic gas flows at respiratory pressure between
125 the fresh-gas inlet, the patient connection port and an exhaust valve or exhaust port
© ISO 2011 – All rights reserved
2

---------------------- Page: 14 ----------------------
oSIST prEN ISO 5367:2012
ISO/DIS 5367

126 [ISO 80601-2-13]
127 3.4
128 antistatic
129 A property of material or a procedure that disperses or inhibits the accumulation of electostatic charges
130 3.5
131 APL valve
132 adjustable pressure-limiting valve
133 pop-off valve
134 pressure-limiting valve which releases gas over an adjustable range of pressures
135 [Adapted from ISO 4135]
136 3.6
137 assembled end
138 end of a breathing tube incorporating an adaptor
139 3.7
140 breathing set
141 assembly of breathing tubes, connectors and components that form the inspiratory and expiratory limbs of the
142 gas pathways of an anaesthetic or ventilator breathing system between the ventilator and the patient's
143 airway device
144 NOTE 1 The exhaust valve is not included
145 NOTE 2 The patient connection port is included
146 [Adapted from ISO 4135:2001, definitions 3.1.6 and 4.1.1, ISO 80601-2-12, definition 201.3.221, and ISO
147 80601-2-13, definition 201.3.203]
148 3.8
149 breathing tube
150 non-rigid tube used to convey gases and/or vapours between components of a breathing system
151 [ISO 4135]
152 3.9
153 compliance
154 volume added per unit pressure increase when gas is added to an enclosed space, expressed at the temperature
155 and humidity of that enclosed space and at an ambient atmospheric pressure
156 [ISO 4135]
157 3.10
158 machine end
159 that end of the breathing set or breathing tube which is intended to be connected to the anaesthetic workstation,
160 ventilator or other breathing system accessory furthest from the patient
161 3.11
162 patient connection port
163 opening at the patient end of a breathing system intended for connection of an airway device such as a tracheal
164 or tracheostomy tube connector, a face mask, a supralaryngeal airway or a test apparatus
165 [Adapted from ISO 4135:2001, 4.2.1.2.]
© ISO 2011 – All rights reserved
3

---------------------- Page: 15 ----------------------
oSIST prEN ISO 5367:2012
ISO/DIS 5367

166 3.12
167 patient end
168 that end of the breathing set or breathing tube which is intended to be connected to the patient end
169 adaptor, Y-piece or other appropriate component near the patient
170 3.13
171 *patient end adaptor
172 tubular connector with multiple ports, one of which is a patient connection port
173 [ISO 4135]
174 NOTE Examples of patient end adaptors include a Y-piece, a swivel adaptor, and other specialized adaptors for
175 coaxial, multiple tubes, and bifurcated tubes. See also Annex A Figures A.1 – A.5)
176 3.14
177 plain end
178 end of a breathing tube designed to fit directly over a male conical connector complying with ISO 5356-1
179 3.15
180 swivel adaptor
181 specialized connector which allows variation in the position of its ports relative to each other
182 [ISO 4135]
183 3.16
184 Y-piece
185 patient end adaptor as a 3-way connector with a patient connection port and two ports for connection to
186 breathing tubes
187 [ISO 4135]
188 3.17
189 VBS
190 ventilator breathing system
191 inspiratory or expiratory gas pathways through which gas flows at respiratory pressures and bounded by the
192 through which fresh gas enters, the patient-connection port and the exhaust port
193 [ISO 80601-2-12]
194 4 3BGeneral requirements
195 4.1 8BRisk management
196 4.1.1 This standard specifies requirements that are generally applicable to risks associated with breathing
197 sets and breathing tubes. An established risk management process shall be applied to the design of the
198 device.
199 NOTE An informative list of identified hazard
...