SIST EN ISO 5361:2016

SLOVENSKI STANDARD
oSIST prEN ISO 5361:2014
01-julij-2014
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Anaesthetic and respiratory equipment - Tracheal tubes and connectors (ISO/DIS
5361:2014)
Anästhesieund Beatmungsgeräte - Trachealtuben und Verbindungsstücke (ISO/DIS
5361:2014)
Matériel d'anesthésie et de réanimation respiratoire - Sondes trachéales et raccords
(ISO/DIS 5361:2014)
Ta slovenski standard je istoveten z: prEN ISO 5361 rev
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
oSIST prEN ISO 5361:2014 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 5361:2014

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oSIST prEN ISO 5361:2014
DRAFT INTERNATIONAL STANDARD
ISO/DIS 5361
ISO/TC 121/SC 2 Secretariat: ANSI
Voting begins on: Voting terminates on:
2014-03-27 2014-08-27
Anaesthetic and respiratory equipment — Tracheal tubes
and connectors
Matériel d’anesthésie et de réanimation respiratoire — Sondes trachéales et raccords
[Revision of second edition (ISO 5361:2012)]
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
THIS DOCUMENT IS A DRAFT CIRCULATED
formal vote in CEN.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
To expedite distribution, this document is circulated as received from the
IN ADDITION TO THEIR EVALUATION AS
committee secretariat. ISO Central Secretariat work of editing and text
BEING ACCEPTABLE FOR INDUSTRIAL,
composition will be undertaken at publication stage.
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
Reference number
NATIONAL REGULATIONS.
ISO/DIS 5361:2014(E)
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. ISO 2014

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oSIST prEN ISO 5361:2014
ISO/DIS 5361:2014(E)

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
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Reproduction may be subject to royalty payments or a licensing agreement.
Violators may be prosecuted.
ii © ISO 2014 – All rights reserved

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oSIST prEN ISO 5361:2014
ISO/DIS 5361
Contents Page
Foreword . 4
Introduction . 5
1 *Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 *General requirements for tracheal tubes and tracheal tube connectors . 5
4.1 Risk assessment. 5
4.2 Safety . 6
5 Specific requirements for tracheal tubes and tracheal tube connectors . 6
5.1 Size designation . 6
5.2 Dimensions . 6
5.3 *Materials . 16
5.4 Tracheal tube bevel . 16
5.5 *Tracheal tube cuffs . 16
5.6 Inflating system for cuffs . 17
5.7 Curvature of the tube . 17
5.8 *Radiopaque marker . 19
5.9 *Kink resistance . 19
6 Additional requirement for tracheal tubes with a Murphy eye . 20
6.1 Size of the Murphy eye . 20
6.2 Location of the Murphy eye . 20
6.3 Resistance to kinking or collapse of the Murphy eye . 20
6.4 Surface characteristics of the Murphy eye . 20
7 Requirements for tracheal tubes with tracheal tube connectors supplied sterile . 21
7.1 Sterility assurance . 21
7.2 Packaging for tracheal tubes and tracheal tube connectors supplied sterile . 21
8 Marking . 21
8.1 Use of symbols . 21
8.2 Tracheal tubes . 21
8.3 Marking on the tracheal tube individual pack or any insert . 22
8.4 Marking on tracheal tube connectors . 24
Annex A (informative) Rationale . 25
Annex B (normative) Determination of cuff diameter . 29
Annex C (normative) Test method for cuffed tube collapse. 30
Annex D (normative) *Test method for cuff herniation . 33
Annex E (informative) Guidance on design of tracheal tube connectors . 35
Annex F (informative) Hazard identification for risk assessment . 36
Annex G (normative) *Test method for tracheal seal . 39
Annex H (normative) Test method to determine kink resistance . 42
Annex ZA (informative) Relationship between this document and the Essential Requirements of
EU Directive 93/42/EEC . 44
Bibliography . 47
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oSIST prEN ISO 5361:2014
ISO/DIS 5361
Foreword
1 ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
2 (ISO member bodies). The work of preparing International Standards is normally carried out through ISO
3 technical committees. Each member body interested in a subject for which a technical committee has been
4 established has the right to be represented on that committee. International organizations, governmental and
5 non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
6 International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
7 International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
8 The main task of technical committees is to prepare International Standards. Draft International Standards
9 adopted by the technical committees are circulated to the member bodies for voting. Publication as an
10 International Standard requires approval by at least 75 % of the member bodies casting a vote.
11 Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
12 rights. ISO shall not be held responsible for identifying any or all such patent rights.
13 ISO 5361 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment,
14 Subcommittee SC 2, Airways and related equipment.
15 This third edition cancels and replaces the second edition (ISO 5361:2012), which has been technically
16 revised.
17 Major changes in this International Standard are highlighted in a BLUE box during the Enquiry phase only.
18 These highlights will be removed during the approval and publication phases.
19 Throughout this Particular Standard, terms defined in Clause 3 or in ISO 4135 appear in bold type.
20 Throughout this Particular Standard, text for which a rationale is provided in Annex A is indicated by an
21 asterisk (*).
22 The attention of Member Bodies and National Committees is drawn to the fact that equipment
23 MANUFACTURERS and testing organizations may need a transitional period following publication of a new,
24 amended or revised ISO or IEC publication in which to make products in accordance with the new
25 requirements and to equip themselves for conducting new or revised tests. It is the recommendation of the
26 committee that the content of this publication not be adopted for mandatory implementation nationally earlier
27 than 3 years from the date of publication for equipment newly designed and not earlier than 5 years from the
28 date of publication for equipment already in production.
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oSIST prEN ISO 5361:2014
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29 Introduction
30 This International Standard provides the essential performance and safety requirements for the design of
31 tracheal tubes and tracheal tube connectors. Tracheal tubes are intended to be inserted through the
32 larynx into the trachea to convey gases and vapours to and from the trachea.
33 Tracheal tubes with cuffs are intended to seal and protect the trachea from aspiration of secretions and to
34 provide an unobstructed airway in patients during spontaneous, assisted, or controlled ventilation for short or
35 prolonged durations.
36 A variety of cuff designs are available to meet particular clinical requirements. Cuff performance requirements
37 with associated test methodsremain unchanged from the second editoin.
38 Requirements for paediatric tracheal tubes with and without cuffs, have been have been updated from the
39 second edition to include revised length marks and new provisions for glottic depth marks have been added
40 in this edition because these are commercially available and in common use.
41 Tracheal tubes are also intended to conform as closely as possible to human anatomy when in position.
42 Clinical considerations have also dictated the specified length of tracheal tubes because long tracheal
43 tubes, sometimes of relatively narrow diameter, may be required and therefore should be readily available.
44 Provision has also been included for pre-cut tracheal tubes.
45 Kink resistance requirements with associated test methods remain unchanged from the second edition, to
46 measure the ability of the shaft of the tracheal tube to resist collapse and increased breathing resistance
47 when bent or curved.
48 Radiopacity requirements and test methods remain unchanged from the second edition, to characterize the
49 visibility of tracheal tubes in X-rays used to determine proper placement of the tube. The requirements of this
50 International Standard were developed using the hazard identification for risk assessment in Annex F.
51
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oSIST prEN ISO 5361:2014
DRAFT INTERNATIONAL STANDARD ISO/DIS 5361

52 Anaesthetic and respiratory equipment — Tracheal tubes and
53 connectors
54 1 *Scope
55 This International Standard provides essential performance and safety requirements for oro-tracheal and
56 naso-tracheal tubes and tracheal tube connectors. Tracheal tubes with walls reinforced with metal or
57 nylon, tracheal tubes with shoulders, tapered tracheal tubes, tracheal tubes with means for suctioning or
58 monitoring or delivery of drugs or other gases, and the many other types of tracheal tubes devised for
59 specialized applications are included in this International Standard, as many specialized tracheal tubes are
60 now commonly used, and all share similar essential requirements as defined in this International Standard.
61 Tracheobronchial (endobronchial) tubes, tracheostomy tubes and supralaryngeal airways are excluded from
62 the scope of this International Standard.
63 Tracheal tubes intended for use with flammable anaesthetic gases or agents, lasers or electrosurgical
64 equipment are outside the scope of this International Standard.
[1][2][3][4]
65 NOTE ISO/TR 11991, ISO 11990-1, ISO 11990-2, and ISO 14408 cover this .
66 2 Normative references
67 The following referenced documents are indispensable for the application of this document. For dated
68 references, only the edition cited applies. For undated references, the latest edition of the referenced
69 document (including any amendments) applies.
70 ISO 594-1, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment
71 — Part 1: General requirements
72 ISO 5356-1, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets
1
73 ISO 7000, Graphical symbols for use on equipment – Index and synopsis
74 ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
75 management process
76 ISO 11135-1, Sterilization of health care products – Ethylene oxide – Part 1: Requirements for development,
77 validation and routine control of a sterilization process for medical devices
78 ISO 11137-1, Sterilization of health care products – Radiation – Part 1: Requirements for development,
79 validation and routine control of a sterilization process for medical devices
80 ISO 11607-1, Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile
81 barrier systems and packaging systems

1
The graphical symbols in ISO 7000 are also available on line in the ISO web store. For more information, consult
http://www.iso.org/iso/publications_and_e-products/databases.htm?=.
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82 ISO 14155, Clinical investigation of medical devices for human subjects – Good clinical practice
83 ISO 14971, Medical Devices - Application of risk management to medical devices
84 ISO 15223-1, Medical devices – Symbols to be used with medical device labels, labelling and information to
85 be supplied – Part 1: General requirements
86 ISO 15223-2, Medical devices – Symbols to be used with medical device labels, labelling, and information to
87 be supplied – Part 2: Symbol development, selection and validation
88 EN 556-1:2001, Sterilization of medical devices - Requirements for medical devices to be designated
89 “STERILE” -Part 1: Requirements for terminally sterilized medical devices
90 EN 1041, Terminology, symbols and information provided with medical devices: Information supplied by the
91 manufacturer of medical devices
92 ASTM F640-2007, Standard test methods for radiopacity for medical use
93 ASTM D3002-2007, Standard guide for evaluation of coatings applied to plastics
94 3 Terms and definitions
[5]
95 For the purposes of this document, the terms and definitions given in ISO 4135 and ISO 14971 and the
96 following apply.
97 3.1
98 angle of bevel
99 acute angle between the plane of the bevel and the longitudinal axis of the tracheal tube at the patient end
100 [ISO 4135:2001, definition 6.3.5]
101 See Figures 1 a), 1 b) and 4.
102 3.2
103 bevel
104 slanted portion at the patient end of a tracheal tube
105 [ISO 4135:2001, definition 6.3.4]
106 See Figures 1 a), 1 b) and 4.
107 3.3
108 Cole-type tracheal tube
109 tracheal tube combining a short laryngo-tracheal portion of small diameter and a longer oral portion of
110 larger diameter with transition from one to the other resulting in a shoulder
111 See Figure 1 c).
112 3.4
113 cuff
114 inflatable balloon permanently attached around the tracheal tube near the patient end and used to provide
115 an effective seal between the tube and the trachea
116 See Figures 1 a) and 1 b).
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117 3.5
118 glottic depth mark
119 an indicator on the tracheal tube to assist in determining the insertion beyond the vocal chords
120 3.6
121 inflating tube
122 tube through which the cuff is inflated
123 [ISO 4135:2001, definition 6.3.6.1]
124 See Figures 1 a) and 1 b).
125 3.7
126 inflation lumen
127 lumen within the wall of the tracheal tube for inflating the cuff
128 3.8
129 laryngo-tracheal portion
130 that portion of a Cole-type tracheal tube of small diameter and extending from the bevel tip to the point at
131 which there is an increase in the outside diameter
132 3.9
133 machine end
134 that end of a tracheal tube which is intended to project from a patient
135 [ISO 4135:2001, definition 6.3.3]
136 See Figures 1 a), 1 b) and 4.
137 3.10
138 machine end of the tracheal tube connector
139 that portion of the tracheal tube connector intended to mate with an anaesthetic breathing system (ABS) or
140 ventilator breathing system (VBS)
141 3.11
142 Magill-type tracheal tube
143 curved tracheal tube with a radius without a Murphy eye and having a bevel at the patient end
144 See 5.7.2 and Figures 1 a), 1 b) and 4.
145 3.12
146 Murphy eye
147 hole through the wall of a tracheal tube near the patient end and on the side opposite to the bevel
148 See Figure 6.
149 3.13
150 naso-tracheal tube
151 tracheal tube for insertion through the nose into the trachea
152 [ISO 4135:2001, definition 6.3.1.2]
153 3.14
154 oral portion
155 that portion of a Cole-type tracheal tube of a larger diameter extending from the machine end to the point at
156 which there is a decrease in the outside diameter
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157 3.15
158 oro-tracheal tube
159 tracheal tube for insertion through the mouth into the trachea
160 [ISO 4135:2001, definition 6.3.1.1]
161 3.16
162 patient end
163 that end of a tracheal tube which is intended to be inserted into the trachea
164 [ISO 4135:2001, definition 6.3.2]
165 See Figures 1 a), 1 b) and 4.
166 3.17
167 patient end of the connector
168 that end of the tracheal tube connector intended to be inserted into the tracheal tube
169 3.18
170 pilot balloon
171 balloon fitted to an inflating tube to indicate inflation of the cuff
172 [ISO 4135:2001, definition 6.3.6.2]
173 See Figure 1 b).
174 3.19
175 risk
176 combination of the probability of occurrence of harm and the severity of that harm
177 [ISO 14971:2007, definition 2.16]
178 3.20
179 risk analysis
180 systematic use of available information to identify hazards and to estimate the risk
181 [ISO 14971:2007, definition 2.17]
182 NOTE Risk analysis includes examination of different sequences of events that can produce hazardous situations
183 and harm (see Annex F and ISO 14971:2007, Annex E).
184 3.21
185 risk assessment
186 overall process comprising a risk analysis and a risk evaluation
187 [SO 14971:2007, definition 2.18]
188 3.22
189 risk evaluation
190 process of comparing the estimated risk against given risk criteria to determine the acceptability of the risk
191 [ISO 14971:2007, definition 2.21]
192 3.23
193 risk management
194 systematic application of management policies, procedures and practices to the tasks of analysing,
195 evaluating, controlling and monitoring risk
196 [ISO 14971:2007, definition 2.22]
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197 3.24
198 risk management file
199 set of records and other documents that are produced by risk management
200 [ISO 14971:2007, definition 2.23]
201 3.25
202 shoulder
203 that portion of a Cole-type tracheal tube at which transition from the oral portion to the laryngo-tracheal
204 portion occurs
205 3.26
206 single-fault condition
207 condition in which a single means for reducing a risk is defective or a single abnormal condition is present
208 3.27
209 tracheal tube
210 tube designed for insertion through the larynx into the trachea to convey gases and vapours to and from the
211 trachea
212 [ISO 4135:2001, definition 6.3.1]
213 3.28
214 tracheal tube connector
215 tubular component that fits directly into the machine end of a tracheal tube
216 [ISO 4135:2005, definition 6.3.8]
217 See Figures 2 and 3.
218 4 *General requirements for tracheal tubes and tracheal tube connectors
219 This International Standard specifies requirements that are generally applicable to risks associated with
220 tracheal tubes and tracheal tube connectors.
221 4.1 Risk assessment
222 4.1.1 An established risk assessment process shall be applied to the design of the device.
223 EXAMPLE ISO 14971.
224 Check compliance by inspection of the risk management file. If clinical studies are performed, these studies
225 shall document measurements taken during the conditions for which performance is claimed. The clinical
226 studies shall comply with the requirements of ISO 14155.
227 NOTE See Annex F.
228 4.1.2 Tracheal tubes shall, when transported, stored, installed, operated in normal use and maintained
229 according to the instructions of the manufacturer, present no risks that are not reduced to an acceptable level
230 using risk management procedures in accordance with ISO 14971 and which are connected with their
231 intended application, in normal and in single fault condition.
232 NOTE A situation in which a fault is not detected is considered a normal condition. Fault conditions/hazardous
233 situations might remain undetected over a period of time and, as a consequence, might lead to an unacceptable risk. In
234 that case, a subsequent detected fault condition needs to be considered as a single fault condition. Specific risk control
235 measures need to be determined within the risk management process to deal with such situations.
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236 4.1.3 Where requirements in this International Standard refer to freedom from unacceptable risk, the
237 acceptability or unacceptability of this risk shall be determined by the manufacturer in accordance with the
238 manufacturer’s policy for determining acceptable risk.
239 Check compliance by inspection of the risk management file.
240 4.1.4 If required by a competent authority, the manufacturer shall address in a usability engineering process
241 the risk resulting from poor usability (see IEC 62366).
242 Check compliance by inspection of the usability engineering file.
243 4.1.5 If required by a competent authority, a clinical evaluation shall be performed and documented in the
244 technical documentation of the device.
245 Check compliance by inspection of the technical documentation.
246 4.1.6 If required by a competent authority, and where appropriate, validated biophysical or modelling
247 research shall be carried out.
248 Check compliance by inspection of the technical documentation.
249 4.2 Safety
250 *4.2.1 Tracheal tubes, when transported, stored, installed, operated in their normal intended use, and
251 maintained according to the instructions of the manufacturer, shall minimize safety hazards which could
252 reasonably be foreseen to occur, in normal and single-fault conditions.
253 Check compliance by inspection of the risk management file.
254 NOTE Attention is drawn to any intended use that may deviate from the currently accepted medical practice. See
255 Annex A for examples.
256 4.2.2 The manufacturer may use type tests different from those detailed within this International Standard, if
257 an equivalent degree of safety is obtained. Alternative test methods shall be validated against the test
258 methods specified in this International Standard.
259 5 Specific requirements for tracheal tubes and tracheal tube connectors
260 5.1 Size designation
261 The size of tracheal tubes and tracheal tube connectors shall be designated in accordance with Table 1a
262 for tracheal tubes, Table 1b for Cole-type tracheal tubes, and Table 2 for tracheal tube connectors.
263 5.2 Dimensions
264 5.2.1 Tracheal tubes
265 5.2.1.1 The basic dimensions of Magill-type tracheal tubes shall be in accordance with Tables 1a and 1b.
266 5.2.1.2 The basic dimensions of Cole-type tracheal tubes shall be in accordance with Table 1b.
267 5.2.1.3 The designated size of the tracheal tube shall be the marked inside diameter subject to a tolerance of
268  0,15 mm for sizes 6,0 and smaller, and subject to a tolerance of  0,20 mm for sizes 6,5 and larger.
269 NOTE The lumen of the tracheal tube should be essentially circular in a plane at right angles to the long axis.
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270 5.2.1.4 For Magill-type tracheal tubes, the nominal outside diameter (OD) shall be the marked outside
271 diameter (OD) subject to a tolerance of  0,15 mm for sizes 6,0 and smaller, or subject to a tolerance of  0,20
272 mm for sizes 6,5 and larger [see 8.2.1.1 b) 1)]. For Cole-type tracheal tubes, the maximum outside diameter
273 of the laryngo-tracheal portion (OD) shall be the marked outside diameter (OD) [see 8.2.1.1 b) 2)].
274 5.2.1.5 For Cole-type tracheal tubes, the axial length of the outside surface of the shoulder region, S S
1 2
275 [see Figure 1 c)], shall not exceed 4 mm for sizes up to and including size 3.
276
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277 Table 1a —*Basic dimensions of tracheal tubes
278 (see Figures 1a and 1b)
279 Dimensions in millimetres
Dimension A Dimension C
a, b
Dimension S
1
Minimum length of tube Maximum distance from
Minimum
...