prEN ISO 10524-3

SLOVENSKI STANDARD
01-maj-2025
Tlačni regulatorji za medicinske pline - 3. del: Tlačni regulatorji v sklopu
cilindričnih ventilov jeklenk (ISO/DIS 10524-3:2025)
Pressure regulators for use with medical gases - Part 3: Pressure regulators integrated
with cylinder valves (VIPRs) (ISO/DIS 10524-3:2025)
Druckminderer zur Verwendung mit medizinischen Gasen - Teil 3: Druckminderer in
Flaschenventilen (ISO/DIS 10524-3:2025)
Détendeurs pour l'utilisation avec les gaz médicaux - Partie 3: Détendeurs intégrés dans
les robinets des bouteilles à gaz (VIPR) (ISO/DIS 10524-3:2025)
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 Tlačni regulatorji Pressure regulators
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

DRAFT
International
Standard
ISO/DIS 10524-3
ISO/TC 121/SC 6
Pressure regulators for use with
Secretariat: ANSI
medical gases —
Voting begins on:
Part 3: 2025-03-10
Pressure regulators integrated with
Voting terminates on:
2025-06-02
cylinder valves (VIPRs)
Détendeurs pour l'utilisation avec les gaz médicaux —
Partie 3: Détendeurs intégrés dans les robinets des bouteilles à
gaz (VIPR)
ICS: 11.040.10
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Reference number
ISO/DIS 10524-3:2025(en)
DRAFT
ISO/DIS 10524-3:2025(en)
International
Standard
ISO/DIS 10524-3
ISO/TC 121/SC 6
Pressure regulators for use with
Secretariat: ANSI
medical gases —
Voting begins on:
Part 3:
Pressure regulators integrated with
Voting terminates on:
cylinder valves (VIPRs)
Détendeurs pour l'utilisation avec les gaz médicaux —
Partie 3: Détendeurs intégrés dans les robinets des bouteilles à
gaz (VIPR)
ICS: ISO ics
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2025
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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Published in Switzerland Reference number
ISO/DIS 10524-3:2025(en)
ii
ISO/DIS 10524-3:2025(en)
14 Contents
15 Introduction . 8
16 1 Scope . 9
17 2 Normative references . 9
18 3 Terms and definitions . 10
19 4 Nomenclature . 13
20 5 General requirements. 13
21 5.1 Safety . 13
22 5.2 Usability . 14
23 5.3 Materials . 14
24 5.4 Potential contamination of the gas pathway . 15
25 5.5 Cleaning and disinfection . 15
26 6 Design requirements . 15
27 6.1 Environmental conditions . 15
28 6.1.1 Road transport and storage . 16
29 6.1.2 VIPR transient operating conditions . 16
30 6.1.3 VIPR clinical use . 16
31 6.2 Integrated electronic device . 16
32 6.3 Filling port . 17
33 6.4 Connections . 18
34 6.4.1 Valve inlet connection . 18
35 6.4.2 Flow outlet . 18
36 6.4.3 Pressure outlet . 18
37 6.5 Content indicator . 18
38 6.6 Filtration . 19
39 6.7 Primary valve operating mechanism . 19
40 6.7.1 General . 19
41 6.7.2 Resistance to excessive torques . 19
42 6.8 Residual pressure . 19
43 6.8.1 Residual pressure device. 19
44 6.8.2 Means of venting the residual pressure . 20
45 6.9 Pressure-relief device. 20
46 6.9.1 General . 20
47 6.9.2 Leakage . 20
48 6.9.3 Opening pressure . 20
49 6.9.4 Closing pressure . 20
50 6.9.5 Minimum discharge capacity . 21
51 6.10 Additional features . 21
52 6.11 Leakage . 21
53 6.11.1 Leakage in transport and storage conditions . 21
54 6.11.2 Internal leak tightness. 21
55 6.11.3 External leak tightness . 21
56 6.11.4 Internal leakage through the pressure regulator valve . 22
57 6.12 Mechanical strength . 22
58 6.12.1 Resistance of the high-pressure side. 22
59 6.12.2 Resistance of the low-pressure side to excessive pressure . 22
60 6.12.3 Resistance of the low-pressure side to P1 . 22
61 6.12.4 Impact test . 22
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ISO/DIS 10524-3:2025(en)
62 6.13 Resistance to ignition . 22
63 6.14 Requirements for VIPR fitted with an integral flow control device . 23
64 6.15 Guard . 23
65 6.16 Endurance . 23
66 6.16.1 Integral flow control device . 23
67 6.16.2 Filling port non-return valve . 23
68 6.16.3 Isolating valve fitted to the filling port . 24
69 6.16.4 Primary valve operating mechanism . 24
70 6.16.5 Pressure regulator . 24
71 7 Performance requirements . 25
72 7.1 VIPRs fitted with a pressure outlet . 25
73 7.1.1 Outlet pressure (P ) limits . 25
74 7.1.2 Multiple pressure outlets . 25
75 7.2 VIPRs fitted with an integral flow control device . 25
76 7.2.1 Flow outlet pressure . 25
77 7.2.2 Stability and accuracy of flow . 25
78 8 Construction requirements . 25
79 8.1 Cleanliness . 25
80 8.2 Lubricants . 26
81 8.3 Loosening torques . 26
82 8.3.1 Filling port . 26
83 8.3.2 Outlet connector . 26
84 8.3.3 Integral flow control device . 26
85 8.3.4 Content indicator. 26
86 8.3.5 Inlet connection . 27
87 9 Marking, and packaging . 27
88 9.1 Marking . 27
89 9.1.1 General . 27
90 9.1.2 Marked information . 27
91 9.2 Packaging . 27
92 10 Instructions for use and technical description . 28
93 10.1 General . 28
94 10.2 Specific requirements for VIPRs . 28
95 10.2.1 Technical description . 28
96 10.2.2 Use of the VIPR . 28
97 10.2.3 Performance information . 28
98 10.2.4 Guard . 28
99 10.2.5 Valve fitting. 28
100 10.2.6 Filling operation . 29
101 10.2.7 Inspection and maintenance operation . 29
102 11 Test methods for non-gas specific type tests . 29
103 11.1 General conditions . 29
104 11.1.1 Ambient conditions . 29
105 11.1.2 Test gas. 29
106 11.1.3 Reference conditions . 30
107 11.2 Test schedule . 30
108 11.3 Test methods for outlet pressure . 32
109 11.3.1 Purpose . 34
110 11.3.2 Test equipment . 34
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111 11.3.3 Test methods for determining outlet pressure limits for VIPRs fitted with a
112 pressure outlet . 35
113 11.3.4 Test method for determining outlet pressure limits for a VIPR only fitted
114 with a flow outlet . 36
115 11.4 Test method for pressure-relief device . 36
116 11.4.1 Purpose . 36
117 11.4.2 Test procedure . 36
118 11.5 Test methods for internal leakage through the pressure regulator valve . 37
119 11.5.1 Purpose . 37
120 11.5.2 Test procedure . 37
121 11.6 Test method for mechanical strength . 37
122 11.6.1 Purpose . 37
123 11.6.2 Test procedure . 37
124 11.7 Test method for resistance to ignition through the valve inlet connection . 38
125 11.7.1 Purpose . 38
126 11.7.2 General . 38
127 11.7.3 Test procedure . 38
128 11.8 Test methods for the stability and accuracy of flow of VIPRs fitted with an
129 integral flow control device . 39
130 11.8.1 Purpose . 39
131 11.8.2 Test procedure . 39
132 11.9 Test method for flow setting torque . 39
133 11.9.1 Purpose . 39
134 11.9.2 Test procedure . 39
135 11.10 Test method for loosening torques. 39
136 11.10.1 Purpose . 39
137 11.10.2 Test procedure . 39
138 11.11 Test for integrity of the filling port non-return valve under high flow
139 condition . 39
140 11.11.1 Purpose . 39
141 11.11.2 Test procedure . 40
142 11.12 Integral flow control device endurance test . 41
143 11.12.1 Purpose . 41
144 11.12.2 Test procedure . 42
145 11.13 Pressure regulator endurance test for VIPRs type A . 42
146 11.13.1 Purpose . 42
147 11.13.2 Test procedure . 42
148 12 Gas-specific type tests . 43
149 12.1 Purpose . 43
150 12.2 Apparatus . 44
151 12.3 General test conditions . 45
152 12.3.1 Test conditions . 45
153 12.4 Test procedure . 45
154 12.4.1 Test method for determining outlet pressure limits for a VIPR fitted with a
155 pressure outlet . 45
156 12.4.2 Test method for stability and accuracy of flow of a VIPR fitted with an
157 integral flow control device . 46
158 12.4.3 Test method for residual pressure device . 46
159 (informative) Example of VIPRs . 47
160 (Normative) Specific requirements for VIPRs intended to supply air or
161 nitrogen for driving surgical tools . 49
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162 B6.4.2 Flow outlet . 49
163 B.6.9 Pressure-relief device. 49
164 (informative) Rationale . 50
165 (informative) How to qualify a VIPR for use in an air (according to EN
[4] [5]
166 13718-1 ) / road (according to EN 1789 ) ambulance . 54
[2]
167 (informative) ASTM G175-24 (Pill Test - Phase 2) Promoted ignition test
168 . 55
169 Bibliography . 56
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171 Foreword
172 ISO (the International Organization for Standardization) is a worldwide federation of national
173 standards bodies (ISO member bodies). The work of preparing International Standards is
174 normally carried out through ISO technical committees. Each member body interested in a subject
175 for which a technical committee has been established has the right to be represented on that
176 committee. International organizations, governmental and non-governmental, in liaison with ISO,
177 also take part in the work. ISO collaborates closely with the International Electrotechnical
178 Commission (IEC) on all matters of electrotechnical standardization.
179 The procedures used to develop this document and those intended for its further maintenance
180 are described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria
181 needed for the different types of ISO documents should be noted. This document was drafted in
182 accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
183 ISO draws attention to the possibility that the implementation of this document may involve the
184 use of (a) patent(s). ISO takes no position concerning the evidence, validity or applicability of any
185 claimed patent rights in respect thereof. As of the date of publication of this document, ISO had
186 not received notice of (a) patent(s) which may be required to implement this document. However,
187 implementers are cautioned that this may not represent the latest information, which may be
188 obtained from the patent database available at www.iso.org/patents. ISO shall not be held
189 responsible for identifying any or all such patent rights.
190 Any trade name used in this document is information given for the convenience of users and does
191 not constitute an endorsement.
192 For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
193 expressions related to conformity assessment, as well as information about ISO's adherence to
194 the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
195 www.iso.org/iso/foreword.html.
196 This document was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory
197 equipment, Subcommittee SC 6, Medical gas supply systems.
198 This third edition cancels and replaces the second edition (ISO 10524-3:2019), which has been
199 technically revised.
200 The main changes are as follows:
201 — reorganisation of the structure of the document
202 — Alignment on the requirements of ISO 10297:2024, Gas cylinders — Cylinder valves —
203 Specification and type testing
204 — Alignment of terms with ISO 10297 and ISO 15002
205 — New requirement regarding the potential contamination of the gas pathway
206 — New requirement regarding cleaning and disinfection
207 — Definition of three temperature ranges
208 — References to colour coding have been removed
209 — Specific requirements for VIPRs intended to supply air or nitrogen for driving surgical
210 tools moved to an normative annex
211 — New informative annex on qualification of a VIPR for use in an air / road ambulance
212 — New informative annex on the promoted ignition test (ASTM G175-24)
213 A list of all parts in the ISO 10524 series can be found on the ISO website.
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214 Any feedback or questions on this document should be directed to the user’s national standards
215 body. A complete listing of these bodies can be found at www.iso.org/members.html.
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ISO/DIS 10524-3:2025(en)
217 Introduction
218 Medicinal gases can be supplied in cylinder fitted with Valves with Integrated Pressure
219 regulators (VIPRs). High pressure cylinders fitted with a VIPR offers the patient and the
220 healthcare professional with a safe and convenient package to administer the gas without
221 having to connect a separate pressure regulator.
222 The VIPR is normally fitted with an integral flow control device incorporating a flow outlet to
223 allow the prescribed flow to be administered and can be fitted with a pressure outlet, using a
224 gas-specific terminal outlet, as used for medical gas pipeline systems.
225 In order for the medicinal gas to be administered safely to the patient, the design
226 specifications and characteristics of the VIPR need to be controlled to ensure that the flows
227 and pressures are compatible with any medical devices used with the cylinder package.
228 This standard describes basic requirements for the VIPRs used with medical gas cylinder
229 packages including:
230 • Suitable materials of construction, compatible with the medicinal gases
231 • Safe design principles, including requirements for:
232 • usability and handling;
233 • mechanical strength,
234 • operational characteristics (flowrates and pressures);
235 • pressure relief systems;
236 • product integrity (leakage);
237 • resistance to ignitions.
238 • Gas-specificity
239 • Cleanliness
240 • Marking
241 • Information for safe usage by the medical gas supplier and the end user
242 The standard describes the approved tests for the type testing of the VIPR and the acceptance
243 limits for the tests.
244 VIPRs also act as the “closure” of gas cylinders, and both gas cylinders and closures are subjected
245 to transport regulations. ISO 10297, Gas cylinders — Cylinder valves — Specification and type
246 testing standard, developed by ISO/TC 58/SC 2 is the ISO cylinder valve (closure) standard
247 referenced in these regulations. ISO 10297 includes industrial and medical VIPRs within its scope
248 and was recently revised,
249 Medical VIPRs are classified as medical devices and have to comply with the medical device
250 regulations. As a medical device standard, ISO 10524-3 is intended to demonstrate conformity
251 with the safety and performance requirements as defined in medical devices regulations and
252 recognised guidelines. As, ISO 10524-3 strives to comprehensively cover all aspects related to
253 safety and performances of the medical VIPR, it makes having a general reference to ISO 10297
254 impractical.
255 In order to reconcile these regulatory constraints and minimize burden on manufacturers, the
256 chosen approach is to replicate the applicable “medical” requirements common to both standards
257 within ISO 10524-3, along with a note indicating alignment with ISO 10297:2024. Some of the
258 requirements of ISO 10297 are not relevant for medical devices and have not been duplicated.
259 However, for those tests methods that are relevant, direct reference to ISO 10297:2024 is made,
260 so avoiding duplication.
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261 1 Scope
262 This document specifies design, type testing, and marking requirements for cylinder valves with
263 integrated pressure regulators [as defined in 3.26 and referred to hereafter as valves with
264 integrated pressure regulators (VIPRs)].
265 Medical VIPRs are designed to be mounted on medical gas cylinders, allowing them to be filled
266 with medical gases for subsequent use as a supply source for other medical devices, such as
267 emergency ventilators, or for the direct administration of medical gases to a patient via an
268 integral flow control device, when fitted.
269 Examples of medical gases include oxygen, medical air and oxygen/nitrous oxide mixtures.
270 Intended use of VIPRs may also encompass the supply of air or nitrogen for driving surgical tools.
271 NOTE See annex B for their specific requirements
272 This document applies to VIPRs mounted on refillable cylinders with a working pressure up to
273 30 000 kPa (300 bar) intended to be filled in cylinder filling facilities or on self-filling systems as
274 used in homecare applications.
275 VIPRs covered by this document are pressure pre-set and provided with a pressure outlet and/or
276 pre-set flow outlet(s).
277 VIPRs used for self-fill systems used in homecare are not covered by this standard, but it can be
278 used as a guide.
279 NOTE The conditions of use for these VIPRs vary significantly, particularly in terms of filling frequency
280 and usage, which can occur daily throughout their lifetime.
281 2 Normative references
282 The following documents are referred to in the text in such a way that some or all of their content
283 constitutes requirements of this document. For dated references, only the edition cited applies.
284 For undated references, the latest edition of the referenced document (including any
285 amendments) applies.
286 ISO 5145, Gas cylinders — Cylinder valve outlets for gases and gas mixtures — Selection and
287 dimensioning
288 ISO 9170-1, Terminal units for medical gas pipeline systems — Part 1: Terminal units for use with
289 compressed medical gases and vacuum
290 ISO 10297:2024, Gas cylinders — Cylinder valves — Specification and type testing
291 ISO 11114-6, Gas cylinders — Compatibility of cylinder and valve materials with gas contents —
292 Part 6: Oxygen pressure surge testing
293 ISO 11117, Gas cylinders — Valve protection caps and valve guards — Design, construction and
294 tests
295 ISO 11363-1, Gas cylinders — 17E and 25E taper threads for connection of valves to gas cylinders
296 — Part 1: Specifications
297 ISO 13341, Gas cylinders — Fitting of valves to gas cylinders
© ISO/DIS 10524-3:2024(1) – All rights reserved
ISO/DIS 10524-3:2025(en)
298 ISO 14971, Medical devices — Application of risk management to medical devices
299 ISO 15001, Anaesthetic and respiratory equipment — Compatibility with oxygen
300 ISO 15245-1, Gas cylinders — Parallel threads for connection of valves to gas cylinders — Part 1:
301 Specification
302 ISO 15996, Gas cylinders — Residual pressure valves — Specification and type testing of cylinder
303 valves incorporating residual pressure devices
304 ISO 17256, Anaesthetic and respiratory equipment — Respiratory therapy tubing and connectors
305 ISO 20417, Medical devices — Information to be supplied by the manufacturer
306 EN 837-1, Pressure gauges — Part 1: Bourdon tube pressure gauges — Dimensions, metrology,
307 requirements and testing
308 3 Terms and definitions
309 For the purposes of this document, the following terms and definitions apply.
310 ISO and IEC maintain terminological databases for use in standardization at the following
311 addresses:
312 — ISO Online browsing platform: available at https://www.iso.org/obp
313 — IEC Electropedia: available at http://www.electropedia.org/
314 3.1
315 accuracy of flow
316 difference between the indicated flow and the measured flow
317 Note 1 to entry: Expressed as a percentage.
318 3.2
319 content indicator
320 device that indicates the cylinder content
321 Note 1 to entry: The content can be expressed either in percentage of content, volume of gas or cylinder
322 pressure.
323 3.3
324 filling adaptor
325 means of connecting the VIPR filling port to the filling system allowing a cylinder fitted with a
326 VIPR to be filled or vented
327 Note 1 to entry: This is not part of the VIPR.
328 Note 2 to entry: It may also be referred to as a filling tool.
329 3.4
330 filling port
331 connector on the VIPR through which the cylinder is filled
332 3.5
333 filling port non-return valve
334 valve which remains closed in normal use thus preventing the flow out of the VIPR's filling port
335 until opened by insertion of an appropriate means and which then permits flow in either
336 direction
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ISO/DIS 10524-3:2025(en)
337 Note 1 to entry: Some filling port non-return valves may also be opened by the pressure of the incoming gas.
338 3.6
339 flow outlet
340 outlet intended to deliver a controlled flow of gas
341 3.7
342 flow selector
343 means for selecting the flow and indicating the flow selected
344 3.8
345 guard
346 A protective device for the VIPR, optionally providing features for handling, bed hanging,
347 aesthetics, and easy cleaning.
348 It can be fixed to the VIPR only or to the cylinder neck.
349 3.9
350 gas-specific
351 having characteristics that prevent connection between different gas services
352 3.10
353 integral flow control device
354 device integrated in the VIPR that enables the delivery of a preset controlled flow of gas via a flow
355 outlet. A flow selector enables the user to choose the desired flow rate from the available settings.
356 3.11
357 nipple
358 portion of a connector which is pushed into and secured within the bore (lumen) of a hose
359 3.12
360 nominal inlet pressure
361 P
362 working pressure of the cylinder specified by the manufacturer of the VIPR for which the VIPR is
363 intended to be used
364 3.14
365 outlet pressure
366 P
367 pressure supplied by the VIPR at the pressure outlet
368 3.15
369 oxidizing gas
370 gas or gas mixture more oxidizing than air
371 EXAMPLE:
372 Any gas or gas mixture that is able, at atmospheric pressure, to support the combustion greater than or
373 equal to a reference oxidizer consisting of 23,5 % oxygen in nitrogen.
[10]
374 Note 1 to entry: Derived from ISO 10156 .
375 3.16
376 pre-set pressure regulator
377 pressure regulator that is not provided with a means of operator adjustment of the outlet pressure
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ISO/DIS 10524-3:2025(en)
378 3.17
379 pressure outlet
380 outlet intended to deliver gas at a controlled pressure
381 3.18
382 pressure regulator
383 device that reduces the inlet pressure and maintains the set outlet pressure within specified limits
384 Note to entry: in ISO 10297, a “pressure regulator” is called a “pressure regulating system”
385 3.19
386 pressure-relief device
387 device intended to relieve excess pressure at a pre-set value
388 3.20
389 primary valve operating mechanism
390 primary mechanism which closes and opens the valve orifice and which includes the internal and
391 external sealing systems
392 Note 1 to entry: In the previous version of this standard, the primary valve operating mechanism was called
393 the main shut-off.
394 Note 2 to entry: For VIPR type B designs, the valve of the pressure regulator acts as the primary valve
395 operating mechanism.
396 Note 3 to entry: For VIPR type C designs, a low pressure shut-off valve or, if not fitted, the pressure outlet
397 check valve and/or the flow selection mechanism acts as the primary valve operating mechanism.
398 Note 4 to entry: in ISO 10297, the primary valve operating mechanism is called the valve operating
399 mechanism
400 3.21
401 residual pressure device
402 RPD
403 device that is designed to prevent ingress of contaminants by maintaining a positive pressure
404 within the cylinder relative to atmosphere by closing off its internal gas passages in the
405 discharging direction
406 [SOURCE:ISO 15996:2017, 3.2]
407 3.22
408 expected service life
409 time period specified by the manufacturer during which the medical device or accessory is
410 expected to remain safe and effective for use
411 [SOURCE: ISO 20417:2020, 3.7]
412 3.23
413 single fault condition
414 condition in which a single means for protection against a safety hazard in equipment is defective
415 or a single external abnormal condition is present
416 3.25
417 valve inlet connection
418 threaded connection of the VIPR which connects it to the cylinder
419 Note 1 to entry: It can also be referred to as the valve stem.
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420 3.26
421 valve with integrated pressure regulator
422 VIPR
423 combination of a pressure regulator and cylinder valve intended to be fitted to a medical gas
424 cylinder
425 3.27
426 VIPR type A
427 VIPR design where the primary valve operating mechanism is located upstream of the pressure
428 regulator
429 Note 1 to entry: For typical designs, see Annex A Fig.A1.
430 [SOURCE:ISO 10297:2024, 3.6]
431 3.28
432 VIPR type B
433 VIPR design where the pressure regulator is also acting as the primary valve operating mechanism
434 Note 1 to entry: For typical designs, see Annex A Fig.A2.
435 [SOURCE:ISO 10297:2024, 3.7]
436 3.29
437 VIPR type C
438 VIPR design where the primary valve operating mechanism is located downstream of the pressure
439 regulator
440 Note 1 to entry: The primary valve operating mechanism can be a flow selector.
441 Note 2 to entry: For typical designs, see Annex A Fig.A3.
442 [SOURCE: ISO 10297:2024, 3.8]
443 3.30
444 working pressure
445 settled pressure of a compressed gas at a uniform reference temperature of 15 °C in a full gas
446 cylinder
447 Note 1 to entry: This definition does not apply to liquefied gases (e.g. carbon dioxide) (adapted from ISO
448 10297).
449 4 Nomenclature
450 The terminology used in this document for components of VIPRs is given in a labelled diagram in
451 Annex A.
452 5 General requirements
453 5.1 Safety
454 a) VIPRs, once fitted to a gas cylinder, and maintained according to the manufacturer's
455 instructions, shall not present any unacceptable risk, as identified, estimated and evaluated using
456 risk management procedures in accordance with ISO 14971, under normal condition or single
457 fault
...