SIST EN ISO 10524-2:2006
(Main)Pressure regulators for use with medical gases - Part 2: Manifold and line pressure regulators (ISO 10524-2:2005)
Pressure regulators for use with medical gases - Part 2: Manifold and line pressure regulators (ISO 10524-2:2005)
ISO 10524-2:2005 specifies requirements for manifold pressure regulators intended to be connected to cylinders with nominal filling pressures up to 25 000 kPa at 15 °C and for line pressure regulators for inlet pressures up to 3 000 kPa and intended for use in pipeline systems for the following medical gases:
oxygen; nitrous oxide; air for breathing; carbon dioxide; oxygen/nitrous oxide mixtures; air for driving surgical tools; nitrogen for driving surgical tools; oxygen produced by an oxygen concentrator.
ISO 10524-2:2005 applies to manifold pressure regulators and line pressure regulators supplied as individual units or to the relevant components incorporated within an assembly. It does not apply to pressure regulators for use with vacuum pipeline systems.
Druckminderer zur Verwendung mit medizinischen Gasen - Teil 2: Hauptstellendruckregler und Leitungsdruckminderer (ISO 10524-2:2005)
1.1 * Dieser Teil von ISO 10524 legt Anforderungen an Hauptstellendruckregler (wie sie in 3.6 definiert sind), die zum Anschluss an Gasflaschen mit einem Nenn-Fülldruck bis zu 25 000 kPa bei 15 °C vorgesehen sind, sowie für Leitungsdruckminderer (wie sie in 3.4 definiert sind) für Vordrücke bis zu 3 000 kPa fest, die zur Verwendung in Rohrleitungssystemen für folgende medizinische Gase vorgesehen sind:
Sauerstoff;
Distickstoffoxid;
Luft für Beatmungszwecke;
Kohlendioxid;
Sauerstoff-/Distickstoffoxidgemisch;
Luft zum Antrieb chirurgischer Werkzeuge;
Stickstoff zum Antrieb chirurgischer Werkzeuge;
Sauerstoff von einem Sauerstoff-Konzentrator.
1.2 * Dieser Teil von ISO 10524 gilt für Hauptstellendruckregler und Leitungsdruckminderer, die als individuelle Einheiten geliefert werden oder für die entsprechenden Bestandteile innerhalb eines zusammen-gebauten Geräts.
1.3 Dieser Teil von ISO 10524 gilt nicht für Druckminderer zur Verwendung mit Rohrleitungssystemen für Vakuum.
ANMERKUNG Anforderungen an Druckminderer zur Verwendung mit Rohrleitungssystemen für Vakuum sind in ISO 10079 3 erfasst.
Détendeurs pour l'utilisation avec les gaz médicaux - Partie 2: Détendeurs de rampes et de canalisations (ISO 10524-2:2005)
L'ISO 10524-2:2005 spécifie les exigences relatives aux détendeurs de rampes, tels que définis en 3.6, destinés à être raccordés à des bouteilles dont la pression d'alimentation maximale est de 25 000 kPa à 15 °C, ainsi qu'aux détendeurs de canalisations, tels que définis en 3.4, pour une pression d'alimentation maximale de 3 000 kPa et destinés à alimenter les réseaux de distribution des gaz médicaux suivants:
l'oxygène;
le protoxyde d'azote;
l'air respirable;
le dioxyde de carbone;
les mélanges oxygène/protoxyde d'azote;
l'air pour les instruments chirurgicaux;
l'azote pour les instruments chirurgicaux;
l'oxygène produit par les concentrateurs d'oxygène.
L'ISO 10524-2:2005 s'applique aux détendeurs de rampes et de canalisations fournis sous la forme d'unités individuelles ou faisant partie d'éléments à assembler.
L'ISO 10524-2:2005 ne s'applique pas aux détendeurs utilisés avec les systèmes d'aspiration.
Tlačni regulatorji za medicinske pline - 2. del: Tlačni regulatorji v razdelilnikih in ceveh (ISO 10524-2:2005)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 10524-2:2006
01-julij-2006
1DGRPHãþD
SIST EN 738-2:2000
7ODþQLUHJXODWRUML]DPHGLFLQVNHSOLQHGHO 7ODþQLUHJXODWRUMLYUD]GHOLOQLNLKLQ
FHYHK ,62
Pressure regulators for use with medical gases - Part 2: Manifold and line pressure
regulators (ISO 10524-2:2005)
Druckminderer zur Verwendung mit medizinischen Gasen - Teil 2:
Hauptstellendruckregler und Leitungsdruckminderer (ISO 10524-2:2005)
Détendeurs pour l'utilisation avec les gaz médicaux - Partie 2: Détendeurs de rampes et
de canalisations (ISO 10524-2:2005)
Ta slovenski standard je istoveten z: EN ISO 10524-2:2006
ICS:
11.040.10
23.060.40
SIST EN ISO 10524-2:2006 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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EUROPEAN STANDARD
EN ISO 10524-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2006
ICS 11.040.10 Supersedes EN 738-2:1998
English Version
Pressure regulators for use with medical gases - Part 2:
Manifold and line pressure regulators (ISO 10524-2:2005)
Détendeurs pour l'utilisation avec les gaz médicaux - Partie Druckminderer zur Verwendung mit medizinischen Gasen -
2: Détendeurs de rampes et de canalisations (ISO 10524- Teil 2: Hauptstellendruckregler und Leitungsdruckminderer
2:2005) (ISO 10524-2:2005)
This European Standard was approved by CEN on 20 March 2006.
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 10524-2:2006: E
worldwide for CEN national Members.
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EN ISO 10524-2:2006 (E)
Contents Page
Foreword.3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC Medical Devices.4
2
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EN ISO 10524-2:2006 (E)
Foreword
The text of ISO 10524-2:2005 has been prepared by Technical Committee ISO/TC 121 "Anaesthetic and
respiratory equipment” of the International Organization for Standardization (ISO) and has been taken over as
EN ISO 10524-2:2006 by 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 October 2006, and conflicting national standards shall be withdrawn at
the latest by October 2006.
This document supersedes EN 738-2: 1998.
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 10524-2:2005 has been approved by CEN as EN ISO 10524-2:2006 without any modifications.
3
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EN ISO 10524-2:2006 (E)
Annex ZA
(informative)
Relationship between this European Standard and the Essential Requirements of
EU Directive 93/42/EEC Medical Devices
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a 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 clauses of this
standard given in table ZA 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 — Correspondence between this European Standard and Directive 93/42/EEC Medical
devices
Essential requirements (ERs) of
Clause(s)/sub-clause(s) of this EN Qualifying remarks/Notes
Directive 93/42/EEC
5 1
5.1 2, 6
5.2 2
5.3 2
5.3.1 7.1, 7.3, 9.3
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
5.4.2. 12.7.1
5.4.3 7.2, 7.6
5.4.4 9.2
5.4.5.1 9.1, 12.7.4
5.4.5.2 9.1, 12.7.4
5.4.5.3 7.5
5.4.5.4 3
5.4.5.5 7.5, 9.2, 12.7.1
5.4.5.6 7.3, 9.3
5.4.6.1 9.1, 12.7.4
5.4.6.2 9.1, 12.7.4
5.4.6.3 7.5
4
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EN ISO 10524-2:2006 (E)
Essential requirements (ERs) of
Clause(s)/sub-clause(s) of this EN Qualifying remarks/Notes
Directive 93/42/EEC
5.4.6.4 3
5.4.6.5 7.3, 9.3
5.5.1 7.2, 9.3
5.5.2 7.2, 9.3
6 3, 7.5, 9.2, 9.3, 12.8.1, 12.8.2
7.1 13.1, 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)
7.1.3, a) 13.1, 13.3 a)
7.2 13.2
7.3 3, 5
7.3.1 5, 7.2, 7.6
7.3.2 13.1, 13.3 b)
8.1 13.1, 13.3 a, 13.4, 13.6 a)
8.2 9.1, 9.2, 9.3, 13.1, 13.6 c), 13.6 d),
13.6 k)
8.3 13.6 b)
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this standard.
5
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INTERNATIONAL ISO
STANDARD 10524-2
First edition
2005-05-01
Pressure regulators for use with medical
gases —
Part 2:
Manifold and line pressure regulators
Détendeurs pour l'utilisation avec les gaz médicaux —
Partie 2: Détendeurs de rampes et de canalisations
Reference number
ISO 10524-2:2005(E)
©
ISO 2005
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ISO 10524-2:2005(E)
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ii © ISO 2005 – All rights reserved
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ISO 10524-2:2005(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope. 1
2 Normative references . 1
3 Terms and definitions. 2
4 Symbols . 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. 9
6 Test methods. 9
6.1 Conditions. 9
6.2 Test methods for manifold pressure regulators. 10
6.3 Test methods for line pressure regulators.16
6.4 Test method for determination of the auto-ignition temperature of sealing materials and
lubricants . 17
6.5 Test method for durability of markings and colour coding. 18
7 Marking, colour coding, packaging. 19
7.1 Marking. 19
7.2 Colour coding. 20
7.3 Packaging . 21
8 Information to be supplied by the manufacturer . 21
Annex A (informative) Examples of pressure regulators . 22
Annex B (informative) Rationale .24
Annex C (informative) Reported regional and national deviations of colour coding and
nomenclature for medical gases . 26
Bibliography . 28
© ISO 2005 – All rights reserved iii
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ISO 10524-2:2005(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 10524-2 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment,
Subcommittee SC 6, Medical gas systems.
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
iv © ISO 2005 – All rights reserved
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ISO 10524-2:2005(E)
Introduction
Manifold pressure regulators are used to reduce cylinder pressure to a lower pressure within a source of
supply of a medical gas pipeline system.
Line pressure regulators are used to reduce the pressure supplied by manifold pressure regulators or by
cryogenic vessels to the lower pressure required at the terminal units of medical gas pipeline systems.
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 manifold and line pressure regulators are specified and
tested in a defined manner.
It is essential that regular inspection and maintenance be undertaken to ensure that the 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);
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 asterisk (*) after their number have corresponding rationale included to
provide additional insight into the reasoning that led to the requirements and recommendations that have been
incorporated into 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.
© ISO 2005 – All rights reserved v
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INTERNATIONAL STANDARD ISO 10524-2:2005(E)
Pressure regulators for use with medical gases —
Part 2:
Manifold and line pressure regulators
1 Scope
1.1* This part of ISO 10524 specifies requirements for manifold pressure regulators (as defined in 3.6)
intended to be connected to cylinders with nominal filling pressures up to 25 000 kPa at 15 °C and for line
pressure regulators (as defined in 3.4) for inlet pressures up to 3 000 kPa and intended for use in pipeline
systems for the following medical gases:
oxygen;
nitrous oxide;
air for breathing;
carbon dioxide;
oxygen/nitrous oxide mixtures;
air for driving surgical tools;
nitrogen for driving surgical tools;
oxygen produced by an oxygen concentrator.
1.2* This part of ISO 10524 applies to manifold pressure regulators and line pressure regulators supplied as
individual units or to the relevant components incorporated within an assembly.
1.3 This part of ISO 10524 does not apply to pressure regulators for use with vacuum pipeline systems.
NOTE Requirements for pressure regulators for use with vacuum pipeline systems are covered in ISO 10079-3.
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 7396-1:2002, Medical gas pipeline systems — Part 1: Pipelines for 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
© ISO 2005 – All rights reserved 1
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ISO 10524-2:2005(E)
EN 837-1:1996, Pressure gauges — Part 1: Bourdon tube pressure gauges — Dimensions, metrology,
requirements and testing
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
closure pressure
P
4
stabilized outlet pressure, after cessation of the flow, from a pressure regulator when the flow has been set to
standard discharge
3.2
double-stage pipeline distribution system
pipeline distribution system in which gas is initially distributed from the supply system at a higher pressure
than the nominal distribution pressure
NOTE This higher pressure (nominal supply system pressure) is then reduced to the nominal distribution pressure by
additional line pressure regulators.
3.3
flow characteristic
variation of outlet pressure in relation to flow with the inlet pressure remaining constant
3.4
line pressure regulator
pressure regulator intended to be installed within a medical gas pipeline system downstream of a manifold
pressure regulator or cryogenic gas supply system
3.5
manifold
device for connecting the outlet(s) of one or more cylinders or cylinder bundles of the same medical gas to a
pipeline system
3.6
manifold pressure regulator
pressure regulator intended to be installed within sources of supply containing cylinders or cylinder bundles
3.7
medical gas pipeline system
complete system which comprises a supply system, a monitoring and alarm system, a pipeline distribution
system with terminal units at the points where medical gases or vacuum may be required
3.8
nominal distribution pressure
pressure of gas which the pipeline system is intended to deliver at the terminal units
3.9
nominal inlet pressure
P
1
upstream pressure (specified as a single value by the manufacturer) for which the pressure regulator is
intended to be used
NOTE P for manifold pressure regulators is the maximum cylinder filling pressure at 15 °C.
1
2 © ISO 2005 – All rights reserved
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ISO 10524-2:2005(E)
3.10
nominal outlet pressure
P
2
downstream pressure for the standard discharge, Q , specified by the manufacturer
1
3.11
pressure characteristic
variation of the outlet pressure in relation to inlet pressure under constant flow conditions
3.12
pressure gauge
device that measures and indicates pressure
3.13
pressure regulator
device that reduces the inlet pressure and maintains the set outlet pressure within specified limits
3.14
pressure-relief valve
device intended to relieve excess pressure at a pre-set value
3.15
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 60601-1:1988, 2.10.11]
3.16
single-stage pipeline distribution system
pipeline distribution system in which gas is distributed from the supply system at the nominal distribution
pressure
3.17
source of supply
that portion of the supply system with associated control equipment, which supplies the pipeline distribution
system
3.18
standard discharge
Q
1
flow for which the pressure regulator is designed to maintain a nominal outlet pressure, P , at test inlet
2
pressure, P
3
3.19
supply system
system that supplies the pipeline distribution system and which includes two or more sources of supply
3.20
test inlet pressure
P
3
minimum inlet test pressure
NOTE See Table 1.
© ISO 2005 – All rights reserved 3
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ISO 10524-2:2005(E)
3.21
test outlet pressure
P
5
highest or lowest value of the outlet pressure resulting from a variation in the inlet pressure between P and P
1 3
at previously adjusted conditions P , P , Q
1 2 1
4 Symbols
The symbols used for the functional characteristics are given in Table 1.
Table 1 — Symbols
P Nominal inlet pressure
1
P Nominal outlet pressure
2
P Test inlet pressure
3
P Closure pressure
4
P Test outlet pressure
5
Q Standard discharge
1
R Coefficient of pressure increase upon closure
i Irregularity coefficient
NOTE P = 2P + 100 kPa
3 2
Examples of a line pressure regulator and a manifold pressure regulator with terminology are given in
Annex A.
5 General requirements
5.1 Safety
Manifold and line 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 and which is connected with their intended
application, in normal condition and in single fault condition.
5.2 Alternative construction
Manifold and line pressure regulators and components or parts thereof, using materials or having forms of
construction different from those detailed in Clause 5 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 Attention is drawn to ISO 14971 on risk management.
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.
4 © ISO 2005 – All rights reserved
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ISO 10524-2:2005(E)
NOTE 1 Corrosion resistance includes resistance against moisture and surrounding materials.
NOTE 2 Compatibility with oxygen involves both combustibility and ease of ignition. Materials which burn in air will burn
violently in pure oxygen. Many materials that do not burn in air will do so in pure oxygen, particularly under pressure.
Similarly, materials that 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.
5.3.2 The materials shall permit the manifold and line pressure regulators and their components to meet the
requirements of 5.4 in the temperature range of − 20 °C to + 60 °C.
NOTE Regional or national environmental conditions may require deviation from this range of temperatures.
5.3.3 Manifold and line 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 Any plating could detach from the component surface.
5.3.5* Aluminium or aluminium alloys shall not be used for components of manifold pressure regulators
whose surfaces come into contact with gas at cylinder pressure in normal or single-fault condition.
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.
5.4 Design requirements
5.4.1 Pressure gauges
5.4.1.1 If a Bourdon tube pressure gauge is used, it shall conform to EN 837-1 (except for the minimum
nominal size) and shall meet the requirements given in 5.4.1.2 to 5.4.1.7. The requirements in 5.4.1.2 to
5.4.1.7 also apply to other types of pressure gauge.
5.4.1.2 The connector shall be a thread complying with EN 837-1 or a proprietary connector.
5.4.1.3 The indicated value of a pressure gauge 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 inlet pressure gauge shall extend to a pressure at least 33 % greater than
nominal inlet pressure, P .
1
NOTE A pressure gauge with a scale range of 0 to 31 500 kPa (315 bar) can be used for a pressure regulator with a
nominal inlet pressure, P , of up to 23 000 kPa.
1
5.4.1.5 The inlet pressure gauge and outlet pressure gauge 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.
© ISO 2005 – All rights reserved 5
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ISO 10524-2:2005(E)
5.4.2 Pressure-adjusting device
5.4.2.1 The pressure regulator shall be provided with a pressure-adjusting device.
5.4.2.2 Except for a line pressure regulator to a single terminal unit for air or nitrogen for driving surgical
tools, the pressure-adjusting device shall be designed so that it can be locked into position and adjusted only
with the use of a tool.
Compliance shall be tested by attempting to adjust the pressure without the use of a tool.
5.4.2.3 The pressure-adjusting device shall be captive or removable only with the use of a tool.
Compliance shall be tested by attempting to remove the pressure-adjusting device without the use of a tool.
5.4.2.4 The pressure regulator shall be designed so that the pressure regulator valve cannot be held in the
open position as a consequence of the pressure regulator spring being compressed to its solid length.
Compliance shall be tested by inspection.
5.4.2.5 Using the pressure-adjusting device it shall not be possible to set a pressure at which the
pressure- relief valve opens.
Compliance shall be tested by inspection.
5.4.3 Filtration
Manifold and line pressure regulators shall be fitted on the inlet side with a filter that prevents particles greater
than 100 µm from entering the pressure regulator.
Evidence of conformity shall be provided by the manufacturer upon request.
NOTE The filter can be a separate item.
5.4.4 Mechanical strength
5.4.4.1 The inlet side of a manifold or line pressure regulator shall be capable of withstanding × 2,25 its
nominal inlet pressure, P , without rupturing. The outlet side of a manifold or line pressure regulator shall be
1
capable of withstanding × 4 its nominal outlet pressure, P , without rupturing.
2
5.4.4.2 Components of the manifold pressure regulator shall not be ejected if the low-pressure chamber
of the pressure regulator is exposed to nominal inlet pressure P (for instance if the pressure regulator valve is
1
held in the open position and the outlet connector is closed). The high-pressure gas shall either be safely
retained or vented.
The tests for mechanical strength of manifold pressure regulators are given in 6.2.6. The test
...
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