SIST EN ISO 10524-1:2006

SLOVENSKI STANDARD
SIST EN ISO 10524-1:2006
01-april-2006
1DGRPHãþD
OSIST prEN ISO 10524-1:2004
SIST EN 738-1:2000
SIST EN 738-1:2000/A1:2002
SIST EN 738-4:2000
SIST EN 738-4:2000/A1:2002
7ODþQLUHJXODWRUML]DPHGLFLQVNHSOLQH±GHO7ODþQLUHJXODWRUMLLQWODþQLUHJXODWRUML
VSUHWRþQLPLPHULOQLNL,62
Pressure regulators for use with medical gases - Part 1: Pressure regulators and
pressure regulators with flow-metering devices (ISO 10524-1:2006)
Druckminderer zur Verwendung mit medizinischen Gasen - Teil 1: Druckminderer und
Druckminderer mit Durchflussmessgeräten (ISO 10524-1:2006)
Détendeurs pour l'utilisation avec les gaz médicaux - Partie 1: Détendeurs et détendeurs
-débimetres (ISO 10524-1:2006)
Ta slovenski standard je istoveten z: EN ISO 10524-1:2006
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
23.060.40 7ODþQLUHJXODWRUML Pressure regulators
SIST EN ISO 10524-1:2006 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 10524-1:2006

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SIST EN ISO 10524-1:2006


EUROPEAN STANDARD
EN ISO 10524-1

NORME EUROPÉENNE

EUROPÄISCHE NORM
February 2006
ICS 11.040.10 Supersedes EN 738-1:1997
English Version
Pressure regulators for use with medical gases - Part 1:
Pressure regulators and pressure regulators with flow-metering
devices (ISO 10524-1:2006)
Détendeurs pour l'utilisation avec les gaz médicaux - Partie Druckminderer zur Verwendung mit medizinischen Gasen -
1: Détendeurs et détendeurs à débitmètre intégré (ISO Teil 1: Druckminderer und Druckminderer mit
10524-1:2006) Durchflussmessgeräten (ISO 10524-1:2006)
This European Standard was approved by CEN on 30 November 2005.

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. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the Central Secretariat or to any CEN member.

This European Standard exists 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 Central Secretariat has the same status as the official
versions.

CEN members are the national standards bodies of Austria, Belgium, 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 and United Kingdom.






EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2006 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10524-1:2006: E
worldwide for CEN national Members.

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SIST EN ISO 10524-1:2006

EN ISO 10524-1:2006 (E)





Foreword


This document (EN ISO 10524-1:2006) 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 European Standard shall be given the status of a national standard, either by publication of
an identical text or by endorsement, at the latest by August 2006, and conflicting national
standards shall be withdrawn at the latest by August 2006.

This document supersedes EN 738-1:1997.

This document has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association, and supports essential requirements of EU
Directive(s).

For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this
document.

According to the CEN/CENELEC Internal Regulations, the national standards organizations of
the following countries are bound to implement this European Standard: Austria, Belgium,
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 and United Kingdom.


Endorsement notice

The text of ISO 10524-1:2006 has been approved by CEN as EN ISO 10524-1:2006 without any
modifications.

2

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SIST EN ISO 10524-1:2006


EN ISO 10524-1:2006 (E)


ANNEX ZA
(informative)

Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42 EEC concerning Medical
Devices

This International Standard has been prepared under a mandate given to CEN by the European

Commission and the European Free Trade Association to provide one means of conforming to
Essential Requirements of the New Approach Directive 93/42 EEC Medical Devices.

Once this standard is cited in the Official Journal of the European Communities under that
Directive and has been implemented as a national standard in at least one Member State,
compliance with the normative clauses of this standard given in Table ZA.1 confers, within the
limits of the scope of this standard, a presumption of conformity with the corresponding Essential
Requirements of that Directive and associated EFTA regulations.

Table ZA.1 — Correspondence between this International Standard and Directive
93/42/EEC


Clause(s)/sub-clause(s) of this Essential requirements (ERs) of EU
Qualifying
International standard
Directive 93/42/EEC
remarks/Notes
5 1
5.1 2, 6
5.2 2
5.3 2
5.3.1 7.1, 7.3, 7.9
5.3.2 4, 7.1, 9.2
5.3.3 3, 5
5.3.4 7.1, 7.2
5.4 2, 3, 4
5.4.1.1 10
5.4.1.3 10.2
5.4.1.4 10.1
5.4.2 9.1, 12.7.4
5.4.3 3, 9.1, 12.7.4
5.4.4 12.3
5.4.5 12.8
5.4.6 12.7.1, 12.8.1
5.4.7 7.2, 7.6, 9.3
5.4.8 7.5, 9.2, 12.7.1
5.4.9 7.5
5.4.10 9.2, 12.7.1
5.4.11 7.3, 9.3
5.4.12.1 10.3, 12.8.2
5.4.12.2 10.2
5.4.12.3 10.1, 12.8.1, 12.8.2
5.4.12.4 10.1, 12.8.1, 12.8.2
5.4.13.1 10.3, 12.8.1, 12.8.2
5.4.13.2 10.1, 12.8.1, 12.8.2
5.4.13.3 10.1, 12.8.1, 12.8.2
5.4.14.1 10.1, 12.8.1, 12.8.2
5.4.14.2 12.8.1, 12.8.2
3

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SIST EN ISO 10524-1:2006

EN ISO 10524-1:2006 (E)


5.4.14.3 12.8.1, 12.8.2
5.4.14.4 10.2
5.5.1 7.2, 9.3
5.5.2 7.1, 9.3
6 3, 7.5, 9.2, 9.3, 12.8.1, 12.8.2
7.1 13, 13.2
7.1.2 a) 13.1, 13.3 a)
7.1.2 b) 13.3 b)
7.1.2 c) 13.3 d), 13.5
7.1.4 a) 13.1, 13.3 a)
7.1.5 12.9
7.2 13.2
7.3 3, 5
7.3.1 5, 7.2, 7.6
7.3.2 13, 13.3 b)
8.1 13.1, 13.3 a), 13.4, 13.6 a)
8.2 13.6 b)
8.3 13.6 b)
8.4 9.1, 9.2, 9.3, 13.1, 13.6 c), 13.6 d)


WARNING: Other requirements and other EU Directives may be applicable to the products
falling within the scope of this standard.



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SIST EN ISO 10524-1:2006

INTERNATIONAL ISO
STANDARD 10524-1
First edition
2006-02-01

Pressure regulators for use with medical
gases —
Part 1:
Pressure regulators and pressure
regulators with flow-metering devices
Détendeurs pour l'utilisation avec les gaz médicaux —
Partie 1: Détendeurs et détendeurs à débitmètre intégré




Reference number
ISO 10524-1:2006(E)
©
ISO 2006

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SIST EN ISO 10524-1:2006
ISO 10524-1:2006(E)
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ii © ISO 2006 – All rights reserved

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SIST EN ISO 10524-1:2006
ISO 10524-1:2006(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope . 1
2 Normative references . 2
3 Terms and definitions. 2
4 Nomenclature . 4
5 General requirements. 4
5.1 Safety . 4
5.2 Alternative construction . 4
5.3 Materials . 4
5.4 Design requirements . 5
5.5 Constructional requirements. 12
6 Test methods. 12
6.1 General. 12
6.2 Test methods for outlet pressure. 13
6.3 Test method for pressure-relief valve. 14
6.4 Test methods for leakage . 14
6.5 Test method for mechanical strength. 15
6.6 Test method for resistance to ignition . 15
6.7 Test method for accuracy of flow of pressure regulators fitted with flowmeters or
flowgauges . 16
6.8 Test method for the stability of flow of pressure regulators fitted with flowmeters or
flowgauges . 16
6.9 Test method for stability and accuracy of flow of pressure regulators fitted with fixed
orifices . 16
6.10 Test method for flow setting and loosening torques. 16
6.11 Test method for durability of markings and colour coding. 16
7 Marking, colour coding, packaging . 16
7.1 Marking . 16
7.2 Colour coding. 18
7.3 Packaging . 18
8 Information to be supplied by the manufacturer. 18
Annex A (informative) Typical examples of pressure regulators and pressure regulators with flow-
metering devices. 22
Annex B (informative) Rationale . 26
Annex C (informative) Reported regional and national deviations of colour coding and
nomenclature for medical gases. 28
Bibliography . 30

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SIST EN ISO 10524-1:2006
ISO 10524-1:2006(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 10524-1 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment,
Subcommittee SC 6, Medical gas systems.
This first edition cancels and replaces ISO 10524:1995 and ISO 10524:1995/Cor 1:1996, which has been
technically revised.
ISO 10524 consists of the following parts, under the general title Pressure regulators for use with medical
gases:
⎯ Part 1: Pressure regulators and pressure regulators with flow-metering devices
⎯ Part 2: Manifold and line pressure regulators
⎯ Part 3: Pressure regulators integrated with cylinder valves
⎯ Part 4: Low-pressure regulators
For the purposes of this part of ISO 10524, the CEN annex regarding fulfilment of European Council
Directives has been removed.
iv © ISO 2006 – All rights reserved

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SIST EN ISO 10524-1:2006
ISO 10524-1:2006(E)
Introduction
A pressure regulator is used to reduce high cylinder pressure to a lower pressure suitable for use with medical
equipment or for delivery of gas directly to a patient.
These functions cover a wide range of inlet and outlet pressures and flows which require specific design
characteristics. It is important that the operating characteristics of the pressure regulators are specified and
tested in a defined manner.
A pressure regulator often has coupled to it a device which controls the flow, such as a flow control valve or a
fixed orifice. The flow can be indicated by a flowmeter or by a flowgauge.
It is essential that regular inspection and maintenance are undertaken to ensure that pressure regulators
continue to meet the requirements of this part of ISO 10524.
This part of ISO 10524 pays particular attention to:
⎯ use of suitable materials;
⎯ safety (mechanical strength, leakage, safe relief of excess pressure and resistance to ignition);
⎯ gas specificity;
⎯ cleanliness;
⎯ type testing;
⎯ marking;
⎯ information supplied by the manufacturer.
Annex B contains rationale statements for some of the requirements of this part of ISO 10524. The clauses
and subclauses marked with an asterix (*) after their number have corresponding rationale, contained in
Annex B, included to provide additional insight into the reasoning that led to the requirements and
recommendations that have been incorporated in this part of ISO 10524. It is considered that knowledge of
the reasons for the requirements will not only facilitate the proper application of this part of ISO 10524, but will
expedite any subsequent revisions.

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SIST EN ISO 10524-1:2006

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SIST EN ISO 10524-1:2006
INTERNATIONAL STANDARD ISO 10524-1:2006(E)

Pressure regulators for use with medical gases —
Part 1:
Pressure regulators and pressure regulators with flow-metering
devices
1 Scope
1.1 This part of ISO 10524 is applicable to the types of pressure regulators listed in 1.3 intended for the
administration of the following medical gases in the treatment, management, diagnostic evaluation and care of
patients:
⎯ oxygen;
⎯ nitrous oxide;
⎯ air for breathing;
⎯ helium;
⎯ carbon dioxide;
⎯ xenon;
⎯ mixtures of the gases listed above;
⎯ air for driving surgical tools;
⎯ nitrogen for driving surgical tools.
1.2* These pressure regulators are intended to be fitted to cylinders with nominal filling pressures up to
25 000 kPa at 15 °C and can be provided with devices which control and measure the flow of the medical gas
delivered.
1.3 The types of pressure regulators covered by this part of ISO 10524 are as follows:
a) pressure regulators intended to be connected to cylinders by the operator;
b) pressure regulators with integral flow-metering devices intended to be connected to cylinders by the
operator;
c) pressure regulators that are an integral part of medical equipment (e.g. anaesthetic workstations, lung
ventilators, resuscitators).
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SIST EN ISO 10524-1:2006
ISO 10524-1:2006(E)
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 32:1977, Gas cylinders for medical use — Marking for identification of content
ISO 407:2004, Small medical gas cylinders — Pin-index, yoke-type valve connections
ISO 5145:2004, Cylinder valve outlets for gases and gas mixtures — Selection and dimensioning
ISO 5359:2000, Low-pressure hose assemblies for use with medical gases
ISO 9170-1:1999, Terminal units for medical gas pipeline systems — Part 1: Terminal units for use with
compressed medical gases and vacuum
ISO 14971:2000, Medical devices — Application of risk management to medical devices
ISO 15001:2003, Anaesthetic and respiratory equipment — Compatibility with oxygen
EN 837-1:1996, Pressure gauges — Part 1: Bourdon tube pressure gauges — Dimensions, metrology,
requirements and testing
EN 13544-2:2002, Respiratory therapy equipment — Part 2: Tubing and connectors
SS 01 91 02, Colour Atlas
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
accuracy of flow
difference between the indicated value and the actual value of the flow expressed in percent
3.2
adjustable pressure regulator
pressure regulator that is provided with a means of operator adjustment of the outlet pressure
3.3
flow outlet
outlet intended to deliver a controlled flow of gas
3.4
flowgauge
device that measures pressure and that is calibrated in units of flow
NOTE The flowgauge does not measure flow. It indicates flow by measuring the pressure upstream of a fixed orifice.
3.5
flowmeter
device that measures and indicates the flow of a specific gas or gas mixture
3.6
gas-specific connection point
that part of the terminal unit that is the receptor for a gas-specific probe
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SIST EN ISO 10524-1:2006
ISO 10524-1:2006(E)
3.7
gas-specific
having characteristics that prevent connection between different gas services
3.8
nipple
that portion of a connector that is pushed into and secured within the bore (lumen) of a hose
3.9
nominal inlet pressure
p
1
upstream pressure specified by the manufacturer for which the pressure regulator is intended to be used
NOTE For compressed gases (e.g. oxygen) p is related to the cylinder filling pressure at 15 °C.
1
3.10
nominal outlet pressure
p
2
nominal downstream pressure
NOTE p is specified by the manufacturer in the instructions for use.
2
3.11
orifice
restriction of known cross-section that delivers a constant flow of gas when supplied with gas at a constant
upstream pressure
NOTE An orifice does not provide an indication of flow.
3.12
preset pressure regulator
pressure regulator that is not provided with a means of operator adjustment of the outlet pressure
3.13
pressure gauge
device that measures and indicates pressure
3.14
pressure outlet
outlet intended to deliver gas at a controlled pressure
3.15
pressure regulator
device that reduces the inlet pressure and maintains the set outlet pressure within specified limits
3.16
pressure-relief valve
device intended to relieve excess pressure at a preset value
3.17
single fault condition
condition in which a single means for protection against a safety hazard in equipment is defective or a single
external abnormal condition is present
[IEC 60601-1]
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SIST EN ISO 10524-1:2006
ISO 10524-1:2006(E)
4 Nomenclature
Examples of pressure regulators with terminology are given in Annex A.
5 General requirements
5.1 Safety
Pressure regulators shall, when transported, stored, installed, operated in normal use and maintained
according to the instructions of the manufacturer, cause no safety hazard which could be foreseen using risk
management procedures in accordance with ISO 14971:2000 and which is connected with their intended
application, in normal condition and in single fault condition.
5.2 Alternative construction
Pressure regulators and components or parts thereof, using materials or having forms of construction different
from those detailed in this clause shall be accepted if it can be demonstrated that an equivalent degree of
safety is obtained.
Such evidence shall be provided by the manufacturer upon request.
NOTE Regional or national regulations can require the provision of evidence to a notified body or competent authority
upon request.
5.3 Materials
5.3.1* The materials in contact with the medical gases listed in 1.1 during normal use shall be resistant to
corrosion and compatible with oxygen, the other medical gases and their mixtures in the temperature range
specified in 5.3.2.
NOTE 1 Corrosion resistance includes resistance against moisture and surrounding materials.
NOTE 2 Oxygen compatibility is usually defined as the ability of a material to coexist with oxygen and a moderate
ignition source. The goal of using oxygen-compatible materials is to develop system designs with low probability of ignition
and low consequence of ignition based on the use of materials exhibiting good compatibility and low energy release if
ignited. Many materials which do not burn in air will do so in pure oxygen, particularly under pressure. Similarly, materials
which can be ignited in air require lower ignition energies for ignition in oxygen. Many such materials can be ignited by
friction at a valve seat or by adiabatic compression produced when oxygen at high pressure is rapidly introduced into a
system initially at low pressure.
NOTE 3 Criteria for the selection of metallic and non-metallic materials are given in ISO 15001:2003.
5.3.2 The materials shall permit the pressure regulator and its components to meet the requirements of 5.4
in the temperature range of −20 °C to +60 °C.
NOTE Regional or national environmental conditions might require deviation from this range of temperatures.
5.3.3 Pressure regulators shall meet the requirements of this part of ISO 10524 after being packed for
transport and storage and being exposed to environmental conditions as stated by the manufacturer.
5.3.4 Springs, highly-strained components and parts liable to wear which come in contact with the medical
gas shall not be plated.
NOTE Plating could come off.
5.3.5* Aluminium or aluminium alloys shall not be used for components whose surfaces come into contact
with gas at cylinder pressure in normal or single-fault condition.
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SIST EN ISO 10524-1:2006
ISO 10524-1:2006(E)
5.3.6 Evidence of conformity with the requirements of 5.3.1, 5.3.2, 5.3.3, 5.3.4 and 5.3.5 shall be provided
by the manufacturer upon request.
NOTE Regional or national regulations might require the provision of evidence to a notified body or competent
authority upon request.
5.4 Design requirements
5.4.1 Pressure gauges and flowgauges
5.4.1.1 If a Bourdon tube pressure gauge or flowgauge is used, it shall conform to EN 837-1:1996
(except for the minimum nominal size) and shall meet the requirements in 5.4.1.2, 5.4.1.3, 5.4.1.4, 5.4.1.5 and
5.4.1.6.
The requirements in 5.4.1.2, 5.4.1.3, 5.4.1.4, 5.4.1.5, 5.4.1.6 and 5.4.1.7 also apply to other types of pressure
gauges and flowgauges.
5.4.1.2 If the gauge connector is threaded, it shall comply with EN 837-1:1996 or a regional or national
standard.
5.4.1.3 The indicated value of a pressure gauge or flowgauge shall be legible to an operator having a
visual acuity of 1 (corrected if necessary) 1 m from the gauge with an illuminance of 215 lx.
5.4.1.4 The scale of the cylinder pressure gauge shall extend to a pressure at least 33 % greater than
nominal inlet pressure p .
1
NOTE In addition to the scale ranges in EN 837-1:1996, a pressure gauge with a scale range of 0 kPa to 31 500 kPa
(315 bar) can also be used.
5.4.1.5 The cylinder pressure gauge, outlet pressure gauge or flowgauge shall be class 2,5 or better in
accordance with EN 837-1:1996.
5.4.1.6 The connector for a pressure gauge with a scale range greater than 4 000 kPa shall be fitted with
2
an orifice with an area no greater than 0,1 mm .
5.4.1.7 Evidence of conformity with the requirements of 5.4.1.1 and 5.4.1.5 shall be provided by the
manufacturer upon request. Compliance with the requirements of 5.4.1.2, 5.4.1.3, 5.4.1.4 and 5.4.1.6 shall be
checked by visual inspection or measurement as required.
NOTE Regional or national regulations might require the provision of evidence to a notified body or competent
authority upon request.
5.4.2 Connectors
5.4.2.1 Inlet connector
There shall be an inlet connector. The inlet connector for connection to cylinders shall comply with either
ISO 407:1991, ISO 5145:2004 or the relevant regional or national standards. See ISO/TR 7470:1988 for
information.
5.4.2.2 Outlet connector
Except for pressure regulators that are an integral part of medical equipment, the outlet connector(s) shall be
in accordance with 5.4.2.2.1 and/or 5.4.2.2.2.
NOTE A pressure regulator can have multiple outlets and can have both a pressure outlet and a flow outlet.
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