SIST EN ISO 10524-3:2019

SLOVENSKI STANDARD
oSIST prEN ISO 10524-3:2017
01-maj-2017
7ODþQLUHJXODWRUML]DPHGLFLQVNHSOLQHGHO7ODþQLUHJXODWRUMLYVNORSXYHQWLORY
MHNOHQN,62',6
Pressure regulators for use with medical gases - Part 3: Pressure regulators integrated
with cylinder valves (VIPRs) (ISO/DIS 10524-3:2017)
Druckminderer zur Verwendung mit medizinischen Gasen - Teil 3: Druckminderer in
Flaschenventilen (ISO/DIS 10524-3:2017)
Détendeurs pour l'utilisation avec les gaz médicaux - Partie 3: Détendeurs intégrés dans
les robinets des bouteilles de gaz (VIPR) (ISO/DIS 10524-3:2017)
Ta slovenski standard je istoveten z: prEN ISO 10524-3
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
23.060.40 7ODþQLUHJXODWRUML Pressure regulators
oSIST prEN ISO 10524-3:2017 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
oSIST prEN ISO 10524-3:2017

---------------------- Page: 2 ----------------------
oSIST prEN ISO 10524-3:2017
DRAFT INTERNATIONAL STANDARD
ISO/DIS 10524-3
ISO/TC 121/SC 6 Secretariat: ANSI
Voting begins on: Voting terminates on:
2017-02-17 2017-05-11
Pressure regulators for use with medical gases —
Part 3:
Pressure regulators integrated with cylinder valves (VIPRs)
Détendeurs pour l’utilisation avec les gaz médicaux —
Partie 3: Détendeurs intégrés dans les robinets des bouteilles de gaz
ICS: 11.040.10
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
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
ISO/CEN PARALLEL PROCESSING
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
Reference number
NATIONAL REGULATIONS.
ISO/DIS 10524-3:2017(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 2017

---------------------- Page: 3 ----------------------
oSIST prEN ISO 10524-3:2017
ISO/DIS 10524-3:2017(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2017, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2017 – All rights reserved

---------------------- Page: 4 ----------------------
oSIST prEN ISO 10524-3:2017
ISO/DIS 10524-3:2017(E)
1 Contents
2 Foreword 5
3 Introduction 8
4 1 * Scope 9
5 Examples of gases include oxygen, medical air and oxygen/nitrous oxide mixtures.This standard
6 applies to VIPR mounted on refillable cylinders with a working pressure up to 30 000 kPa (300
7 bar) intended to be filled in cylinder filling facilities or on self-filling systems as used in
8 homecare applications. VIPRs can be adjustable or pre-set and provided with a pressure outlet
9 and/or flow outlet. 9
10 2 Normative References 9
11 3 Terms and definitions 10
12 4 Nomenclature 12
13 5 General Requirements 12
14 5.1 Safety. 12
15 5.2 Usability . 13
16 5.3 Alternative construction . 13
17 5.4 Materials . 13
18 6 Design Requirements 14
19 6.1 General . 14
20 6.2 Integrated electronic device. 15
21 6.3 Filling port . 15
22 6.4 Connections. 16
23 6.5 * Requirements for Outlet pressure . 17
24 6.6 Indicator for cylinder pressure or cylinder content. 18
25 6.7 Flow control and indication. 18
26 6.8 Pressure-adjusting device. 18
27 6.9 * Filtration . 19
28 6.10 MAIN SHUT-OFF. 19
29 6.11 * RESIDUAL PRESSURE DEVICE. 19
30 6.12 PRESSURE RELIEF VALVE . 19
31 6.13 Leakage. 20
32 6.14 Mechanical strength . 20
33 6.15 * Resistance to ignition . 21
34 6.16 Requirements for VIPR fitted with fixed orifices. 22
35 6.17 Endurance. 22
36 7 Construction Requirements 23
37 7.1 * Cleanliness. 23
38 7.2 Lubricants. 23
39 7.3 Loosening torques . 23
40 8 Test methods for type tests 24
41 8.1 General Conditions. 24
42 8.2 Test Schedule . 25
43 8.3 Test Methods for outlet pressure. 25
44 8.4 Test method for PRESSURE RELIEF VALVE . 27
45 8.5 Test methods for leakage . 27
46 8.6 Test method for mechanical strength. 28
© ISO 2017 – All rights reserved

---------------------- Page: 5 ----------------------
oSIST prEN ISO 10524-3:2017
ISO/DIS 10524-3:2017(E)
47 8.7 Test method for resistance to ignition . 28
48 8.8 Test method for the stability and ACCURACY OF FLOW of VIPRs fitted with fixed orifices . 31
49 8.9 Test method for flow setting and loosening torques . 31
50 8.10 Endurance test method for the FILLING PORT non-return valve . 31
51 8.11 Test for integrity of the non-return valve under high flow condition . 31
52 8.12 Test method for durability of markings and colour coding. 32
53 8.13 Flow selector endurance test . 32
54 8.14 Non-return valve endurance test . 32
55 8.15 PRESSURE REGULATOR endurance test . 33
56 9 Test methods for operational tests 34
57 9.1 General Conditions. 34
58 9.2 Test method for determining outlet pressure limits for a VIPR fitted with a PRESSURE OUTLET . 35
59 9.3 Test method for stability and accuracy of flow of a VIPR fitted with fixed orifices . 36
60 9.4 Test method for RESIDUAL PRESSURE DEVICE. 36
61 10 Marking, Colour Coding, and Packaging 37
62 10.1 Marking . 37
63 10.2 Colour coding. 38
64 10.3 Packaging. 38
65 11 Information to be supplied by the manufacturer 38
66 Annex A (informative) Examples of VIPRs 41
67 Annex B (informative) Rationale 42
68 Annex C (normative) Rationale Reported regional and national deviations of colour coding and
69 nomenclature for medical gases 45
70 Annex D (informative) Terminology-Alphabetized index of defined terms 47
71 Annex ZA (informative) Relationship between this Document and the Essential Requirements of
72 EU Directive 93/42/EEC 48
73 Bibliography 49
74
4 © ISO 2017 – All rights reserved

---------------------- Page: 6 ----------------------
oSIST prEN ISO 10524-3:2017
ISO/DIS 10524-3:2017(E)
75 Foreword
76 ISO (the International Organization for Standardization) is a worldwide federation of national
77 standards bodies (ISO member bodies). The work of preparing International Standards is normally
78 carried out through ISO technical committees. Each member body interested in a subject for which a
79 technical committee has been established has the right to be represented on that committee.
80 International organizations, governmental and non-governmental, in liaison with ISO, also take part in
81 the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all
82 matters of electrotechnical standardization.
83 The procedures used to develop this document and those intended for its further maintenance are
84 described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
85 different types of ISO documents should be noted. This document was drafted in accor dance with the
86 editorial rules of the ISO/IEC Directives, Part 2. www.iso.org/directives
87 Attention is drawn to the possibility that some of the elements of this document may be the subject of
88 patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
89 any patent rights identified during the development of the document will be in the Introduction and/or
90 on the ISO list of patent declarations received. www.iso.org/patents
91 Any trade name used in this document is information given for the convenience of users and does not
92 constitute an endorsement.
93 For an explanation on the meaning of ISO specific terms and expressions related t o conformity
94 assessment, as well as information about ISO's adherence to the WTO principles in the Technical
95 Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information
96 The committee responsible for this document is ISO/TC121 Anaesthetic and Respiratory
97 Equipment/SC6 Medical Gas Systems.
98 This is the second edition of ISO 10524-3, and should be read in conjunction with ISO 10524-1, 10524-2
99 and 10524-4. This replaces standard ISO 10524-3:2005 + A1:2013.
100 ISO 10524 consists of the following parts, under the general title Pressure regulators integrated with
101 cylinder valves for use with medical gases:
102  Part 1: Pressure regulators and pressure regulators with flow-metering devices
103  Part 2: Manifold and line pressure regulators
104  Part 3: Pressure regulators integrated with cylinder valves
105  Part 4: Low-pressure regulators
106 This edition includes the following significant changes with respect to the previous edition:
107 a) Introduction of the acronym VIPR for designating the Valve with Integrated Pressure Regulator and
108 in ISO 10297 and ISO 22435.
109 b) Extension of the scope to include VIPRs with a nominal inlet pressure up to 30 000 kPa (300 bar)
110 c) Restructuring of the document to the new ISO template and associated renumbering.
© ISO 2017 – All rights reserved 5

---------------------- Page: 7 ----------------------
oSIST prEN ISO 10524-3:2017
ISO/DIS 10524-3:2017(E)
111 d) Removal of the requirements for VIPS fitted with flow metering devices and flow gauges.
112 e) Alignment of the common requirements of ISO 10524-1 and ISO 10524-2.
113 f) Cross-reference to ISO 10297 for all requirements concerning the main shut-off.
114 g) Rationalisation of impact test requirements to comply with ISO 10297 and requirements for drop
115 testing in line with ISO 11117.
116 h) Introduction of endurance testing on flow selector, non-return valve, and pressure regulator.
117 i) Introduction of operational testing with the intended gas.
118 j) Introduction of a complete test schedule.
119 k) Review of all type tests.
120 In this standard, the following print types are used:
121  Requirements and definitions: roman type.
122  Informative material appearing outside of tables, such as notes, examples and references: smaller type. Normative text of
123 tables is also in a smaller type.
124  Test specifications: italic type
125  TERMS DEFINED IN CLAUSE 3 OF THIS STANDARD OR AS NOTED: SMALL CAPITALS TYPE.
126 In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
127 combination of the conditions is true.
128 The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC
129 Directives, Part 2. For the purposes of this standard, the auxiliary verb:
130  “shall” means that compliance with a requirement or a test is mandatory for compliance with this
131 standard;
132  “should” means that compliance with a requirement or a test is recommended but is not mandatory
133 for compliance with this standard;
134  “may” is used to describe a permissible way to achieve compliance with a requirement or test.
135 An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates
136 that there is guidance or rationale related to that item in Annex B.
137 The attention of Member Bodies is drawn to the fact that equipment manufacturers and testing
138 organizations may need a transitional period following publication of a new, amended or revised ISO
139 publication in which to make products in accordance with the new requirements and to equip
140 themselves for conducting new or revised tests. It is the recommendation of the committee that the
141 content of this publication be adopted for implementation nationally not earlier than 3 years from the
142 date of publication for equipment newly designed and not earlier than 5 years from the date of
143 publication for equipment already in production.
6 © ISO 2017 – All rights reserved

---------------------- Page: 8 ----------------------
oSIST prEN ISO 10524-3:2017
ISO/DIS 10524-3:2017(E)
144 European Foreword
145 The following referenced documents are indispensable for the application of this document. For
146 undated references, the latest edition of the referenced document (including any amendments) applies.
147 For dated references, only the edition cited applies. However, for any u se of this standard “within the
148 meaning of Annex ZA", the user should always check that any referenced document has not been
149 superseded and that its relevant contents can still be considered the generally acknowledged state -of-
150 art.
151 When the ISO or IEC standard is referred to in the ISO text standard, this must be understood as a
152 normative reference to the parallel EN standard or dated ISO standard, as outlined below, including the
153 foreword and the Annexes ZZ.
154 NOTE The way in which these references documents are cited in normative requirements determines the
155 extent (in whole or in part) to which they apply.
156 Table – Correlations between normative references and dated EN and ISO/IEC standards
Equivalent dated standard
Normative references as listed
in Clause 2
EN ISO/IEC
ISO XXXXX EN ISO XXXXX ISO XXXXX
ISO XXXXX EN XXXXX ISO XXXXX
157
© ISO 2017 – All rights reserved 7

---------------------- Page: 9 ----------------------
oSIST prEN ISO 10524-3:2017
ISO/DIS 10524-3:2017(E)
158 Introduction
159 Pressure regulators integrated with cylinder valves (VIPRs) are used to reduce high cylinder pressure
160 to a lower pressure suitable for use with medical equipment or for delivery of gas directly to a patient.
161 These functions cover a wide range of inlet and outlet pressures and flows which require specific design
162 characteristics. It is important that the operating characteristics of VIPRs are specified and tested in a
163 defined manner.
164 A pressure regulator normally has coupled to it a device which controls the flow, such as a flow control
165 device or a fixed orifice. The flow can be indicated by a FLOW GAUGE.
166 It is essential that regular inspection and maintenance be undertaken to ensure that the VIPR continues
167 to meet the requirements of this part of ISO 10524.
168 This part of ISO 10524 pays particular attention to:
169  use of suitable materials;
170  safety (mechanical strength, leakage, safe relief of excess pressure and resistance to ignition);
171  gas specificity;
172  cleanliness;
173  type testing;
174  marking;
175  information supplied by the manufacturer.
176 Annex B contains rationale statements for some of the requirements of this part of ISO 10524. The
177 clauses and subclauses marked with an asterisk (*) after their number have corresponding rationale
178 included to provide additional insight into the reasoning that led to the requirements and
179 recommendations that have been incorporated into this part of ISO 10524. It is considered that
180 knowledge of the reasons for the requirements will not only facilitate the proper application of this part
181 of ISO 10524, but will expedite any subsequent revisions.
8 © ISO 2017 – All rights reserved

---------------------- Page: 10 ----------------------
oSIST prEN ISO 10524-3:2017
ISO/DIS 10524-3:2017(E)
182 Pressure regulators for use with medical gases — Part 3: Pressure
183 regulators integrated with cylinder valves (VIPR)
184 1 * Scope
185 This International Standard specifies design, type testing, and marking requirements for cylinder valves
186 with integrated pressure regulators (as defined in 3.22 and referred to hereafter as Valves with
187 Integrated Pressure regulators (VIPRs) intended for the administration of medical gases in the
188 treatment, management, diagnostic evaluation and care of patients or for gases used for driving surgical
189 tools.
190 Examples of gases include oxygen, medical air and oxygen/nitrous oxide mixtures.This standard applies
191 to VIPR mounted on refillable cylinders with a working pressure up to 30 000 kPa (300 bar) intended to
192 be filled in cylinder filling facilities or on self-filling systems as used in homecare applications. VIPRs
193 can be adjustable or pre-set and provided with a pressure outlet and/or flow outlet.
194 2 Normative References
195 The following documents, in whole or in part, are normatively referenced in this document and are
196 indispensable for its application. For dated references, only the edition cited applies. For undated
197 references, the latest edition of the referenced document (including any amendments) applies.
198 ISO 32:1977, Gas cylinders for medical use — Marking for identification of content
199 ISO 5145:2014, Cylinder valve outlets for gases and gas mixtures — Selection and dimensioning
200 ISO 7000:2014, Graphical symbols for use on equipment — Registered symbols
201 ISO 7396-1:2016, Medical gas pipeline systems — Part 1: Pipelines for compressed medical gases and vacuum (new
202 edition)
203 ISO/TR 7470:1988, Valve outlets for gas cylinders — List of provisions which are either standardized or in use
204 ISO 9170-1:2008, Terminal units for medical gas pipeline systems — Part 1: Terminal units for use with compressed
205 medical gases and vacuum
206 ISO 10156:2010, Gases and gas mixtures — Determination of fire potential and oxidizing ability for the selection of
207 cylinder valve outlets
208 ISO 10297:—1), Transportable gas cylinders — Cylinder valves — Specification and type testing
209 ISO 11117:1998, Gas cylinders — Valve protection caps and valve guards for industrial and medical gas cylinders —
210 Design, construction and tests
211 ISO 11361-1:2010, Gas cylinders — 17E and 25E taper threads for connection of valves to gas cylinders — Part 1:
212 Specifications
213 ISO 13341:1997, Transportable gas cylinders — Fitting of valves to gas cylinders
214 ISO 14971:2012, Medical devices — Application of risk management to medical devices
215 ISO 15001:2010, Anaesthetic and respiratory equipment — Compatibility with oxygen
216 ISO 15245-1:2001, Gas cylinders — Parallel threads for connection of valves to gas cylinders — Part 1: Specification
© ISO 2017 – All rights reserved 9

---------------------- Page: 11 ----------------------
oSIST prEN ISO 10524-3:2017
ISO/DIS 10524-3:2017(E)
217 ISO 15996: 2005, Gas cylinders -- Residual pressure valves -- General requirements and type testing
218 ISO 22435:2007, Gas cylinders — Cylinder valves with integrated pressure regulators — Specification and type
219 testing
220 EN 837-1:1996, Pressure gauges — Part 1: Bourdon tube pressure gauges — Dimensions, metrology, requirements
221 and testing
222 EN 13544-2:2002, Respiratory therapy equipment — Part 2: Tubing and connectors
223 IEC 60529:2013, Degrees of protection provided by enclosures (IP Code)
224 IEC 60601-1:2005+A1:2012, Medical electrical equipment — Part 1: General requirements for safety
225 IEC 62366, Usability of medical devices
226 3 Terms and definitions
227 For the purposes of this document, the following terms and definitions apply.
228 3.1
229 ACCURACY OF FLOW
230 Difference between the indicated flow and themeasured flow, expressed as a percentage
231 3.2
232 ADJUSTABLE PRESSURE REGULATOR
233 Pressure regulator that is provided with a means of operator adjustment of t he outlet pressure
234 3.3
235 CONTENT INDICATOR
236 Device that displays the amount gas remaining in the cylinder.
237 Note: the content can be expressed either in percentage of content, volume of gas or cylinder pressure.
238 3.4
239 FILLING ADAPTOR
240 The means of connecting the VIPR FILLING PORT to the filling system allowing the cylinder fitted with a
241 VIPR to be filled or vented.
242
243 Note1: this is not part of the VIPR
244 Note 2: It may also be referred to as a filling tool.
245
246 3.5
247 FILLING PORT
248 Connector on the pressure regulator through which the cylinder is filled
249 3.6
250 FLOW OUTLET
251 Outlet intended to deliver a controlled flow of gas
252
10 © ISO 2017 – All rights reserved

---------------------- Page: 12 ----------------------
oSIST prEN ISO 10524-3:2017
ISO/DIS 10524-3:2017(E)
253 3.7
254 GAS SPECIFIC
255 Having characteristics that prevent connection between different gas services
256 3.8
257 GAS SPECIFIC CONNECTION POINT
258 That part of the terminal unit which is the receptor for a GAS SPECIFIC probe
259 3.9
260 LIFETIME
261 Time period during which a VIPR can be used to refill a cylinder
262
263 NOTE TO ENTRY-the VIPR can be used after its operational lifetime up to the expiry date of the filled medical gas
264
265 3.10
266 MAIN SHUT-OFF
267 Primary mechanism which closes and opens the valve orifice and which includes the internal and
268 external sealing systems.
269 NOTE 1 to entry: In ISO 10297 the MAIN SHUT-OFF is called valve operating mechanism
270 NOTE 2 to entry: For some VIPR designs the pressure regulating valve acts as the shut-off mechanism.
271 3.11
272 NOMINAL INLET PRESSURE
273 P
1(15)
274 Upstream WORKING PRESSURE specified by the manufacturer for which the pressure regulator is
275 intended to be used
276 3.12
277 NIPPLE
278 That portion of a connector which is pushed into and secured within the bore (lumen) of a hose
279 3.13
280 NOMINAL OUTLET PRESSURE
281 P
2
282 Nominal downstream pressure under flow conditions specified by the manufacturer
283 3.14
284 OXIDISING GAS
285 Any gas or gas mixture more oxidizing than air, i.e. any gas or gas mixture that is able, at atmospheric
286 pressure, to support the combustion greater than or equal to a reference oxidizer consisting of 23,5 %
287 oxygen in nitrogen
288 [derived from ISO 10156:2010 ]
289 3.15
290 PRE-SET PRESSURE REGULATOR
291 Pressure regulator that is not provided with a means of operator adjustment of the outlet pressure
292 3.16
293 PRESSURE GAUGE
294 Device that measures and indicates pressure
© ISO 2017 – All rights reserved 11

---------------------- Page: 13 ----------------------
oSIST prEN ISO 10524-3:2017
ISO/DIS 10524-3:2017(E)
295 3.17
296 PRESSURE OUTLET
297 Outlet intended to deliver gas at a controlled pressure
298 3.18
299 PRESSURE REGULATOR
300 Device that reduces the inlet pressure and maintains the set outlet pressure within specified limits
301 3.19
302 PRESSURE RELIEF VALVE
303 Device intended to relieve excess pressure at a pre-set value
304 3.20
305 RESIDUAL PRESSURE DEVICE
306 Means for retaining a minimum pressure within a cylinder
307 3.21
308 PRESSURE REGULATOR INTEGRATED WITH CYLINDER VALVE (VIPR)
309 Combination of a PRESSURE REGULATOR and cylinder valve intended to be fitted to a medical gas cylinder
310 3.22
311 SINGLE FAULT CONDITION
312 Condition in which a single means for protection against a safety hazard in equipment is defective or a
313 single external abnormal condition is present
314 3.23
315 VALVE INLET CONNECTION
316 Threaded connection of the VIPR which connects it to the cylinder
317 NOTE 1 to entry: it can also be referred to as the valve stem
318
319 3.24
320 WORKING PRESSURE
321 Settled pressure of a compressed gas at a uniform reference temperature of 15°C in a full gas cylinder
322 NOTE This definition does not apply to liquefied gases (e.g. carbon dioxide) or dissolved gases (e.g. acetylene).
323 4 Nomenclature
324 Examples of VIPRs with terminology are given in Annex A.
325 5 General Requirements
326 5.1 Safety
327 VIPRs shall, when transported, stored, installed,
...