ASTM G175-13(2021)
(Test Method)Standard Test Method for Evaluating the Ignition Sensitivity and Fault Tolerance of Oxygen Pressure Regulators Used for Medical and Emergency Applications
Standard Test Method for Evaluating the Ignition Sensitivity and Fault Tolerance of Oxygen Pressure Regulators Used for Medical and Emergency Applications
SIGNIFICANCE AND USE
4.1 This test method comprises two phases and is used to evaluate the ignition sensitivity and fault tolerance of oxygen pressure regulators used for medical and emergency applications.
4.2 Phase 1: Oxygen Pressure Shock Test—The objective of this test phase is to determine whether the heat or temperature from oxygen pressure shocks will result in burnout or visible heat damage to the internal parts of the pressure regulator.
4.2.1 The criteria for a valid test are specified in ISO 10524–1, Section 6.6 for oxygen pressure regulators and ISO 10524–3, Section 6.6 for oxygen VIPRs.
4.2.2 The pass/fail criteria for a pressure regulator are specified in ISO 10524–1, Section 6.6 for oxygen pressure regulators and ISO 10524–3, Section 6.6 for oxygen VIPRs.
4.3 Phase 2: Promoted Ignition Test—
4.3.1 Oxygen Pressure Regulator—The objective of this test phase is to determine if an ignition event upstream of the pressure regulator inlet filter will result in sustained combustion and burnout of the pressure regulator.
4.3.1.1 The criterion for a valid test is either, (1) failure of the pressure regulator, as defined in 4.3.1.2, or (2) if the pressure regulator does not fail, consumption of at least 90 % of the ignition pill as determined by visual inspection or mass determination.
4.3.1.2 Failure of the pressure regulator is defined as the breach of the pressurized regulator component (burnout), which may include the CGA 870 seal ring, and ejection of molten or burning metal or any parts, including the gauge, from the pressure regulator. See Appendix X6 Testing Pressure Regulators and VIPRs with Gauges. However, momentary (less than 1 s) ejection of flame through normal vent paths, with sparks that look similar to those from metal applied to a grinding wheel, is acceptable and does not constitute a failure.
4.3.2 Oxygen VIPR—The objective of this test is to determine if an ignition event upstream of the shut-off valve or within the shut-off valve will resu...
SCOPE
1.1 For the purpose of this standard, a pressure regulator, also called a pressure-reducing valve, is a device intended for medical or emergency purposes that is used to convert a medical or emergency gas pressure from a high, variable pressure to a lower, more constant working pressure [21 CFR 868.2700 (a)]. Some of these oxygen pressure regulators are a combination of a pressure regulator and cylinder valve. These devices are often referred to as valve integrated pressure regulators, or VIPRs.
1.2 This standard provides an evaluation tool for determining the ignition sensitivity and fault tolerance of oxygen pressure regulators and VIPRs used for medical and emergency applications. An ignition-sensitive pressure regulator or VIPR is defined as having a high probability of ignition as evaluated by rapid pressurization testing (Phase 1). A fault-tolerant pressure regulator or VIPR is defined as having a low consequence of ignition as evaluated by forced ignition testing (Phase 2).
Note 1: It is essential that a risk assessment be carried out on breathing gas systems, especially concerning toxic product formation due to ignition or decomposition of nonmetallic materials as weighed against the risk of flammability (refer to Guide G63 and ISO 15001.2). See Appendix X1 and Appendix X2 for details.
1.3 This standard applies only to:
1.3.1 Oxygen pressure regulators used for medical and emergency applications that are designed and fitted with CGA 540 inlet connections, CGA 870 pin-index adapters (CGA V-1), or EN ISO 407 pin-index adapters.
1.3.2 Oxygen VIPRs used for medical and emergency applications that are designed to be permanently fitted to a medical gas cylinder.
1.4 This standard is a test standard not a design standard; This test standard is not intended as a substitute for traditional design requirements for oxygen cylinder valves, pressure regulators and VIPRs. A well-designed pressure regulator or ...
General Information
Standards Content (Sample)
This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: G175 − 13 (Reapproved 2021)
Standard Test Method for
Evaluating the Ignition Sensitivity and Fault Tolerance of
Oxygen Pressure Regulators Used for Medical and
1
Emergency Applications
This standard is issued under the fixed designation G175; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope design requirements for oxygen cylinder valves, pressure
regulators and VIPRs. A well-designed pressure regulator or
1.1 For the purpose of this standard, a pressure regulator,
VIPR should consider the practices and materials in standards
also called a pressure-reducing valve, is a device intended for
suchasGuidesG63,G88,G94,andG128,PracticeG93,CGA
medical or emergency purposes that is used to convert a
E-18, CGA E-7, ISO 15001, ISO 10524-1 and ISO 10524-3.
medical or emergency gas pressure from a high, variable
pressure to a lower, more constant working pressure [21 CFR
NOTE 2—Medical applications include, but are not limited to, oxygen
868.2700 (a)]. Some of these oxygen pressure regulators are a
gasdeliveryinhospitalsandhomehealthcare,andemergencyapplications
combination of a pressure regulator and cylinder valve. These
including, but not limited to, oxygen gas delivery by emergency person-
devices are often referred to as valve integrated pressure
nel.
regulators, or VIPRs.
1.5 This standard is also intended to aid those responsible
1.2 This standard provides an evaluation tool for determin-
for purchasing or using oxygen pressure regulators and VIPRs
ing the ignition sensitivity and fault tolerance of oxygen
used for medical and emergency applications by ensuring that
pressureregulatorsandVIPRsusedformedicalandemergency
selected pressure regulators are tolerant of the ignition mecha-
applications. An ignition-sensitive pressure regulator or VIPR
nisms that are normally active in oxygen systems.
is defined as having a high probability of ignition as evaluated
by rapid pressurization testing (Phase 1). A fault-tolerant
1.6 This standard does not purport to address the ignition
pressure regulator or VIPR is defined as having a low conse-
sensitivity and fault tolerance of an oxygen regulator or VIPR
quence of ignition as evaluated by forced ignition testing
caused by contamination during field maintenance or use.
(Phase 2).
Pressure regulator and VIPR designers and manufacturers
should provide design safeguards to minimize the potential for
NOTE 1—It is essential that a risk assessment be carried out on
breathing gas systems, especially concerning toxic product formation due
contamination or its consequences (see Guide G88).
to ignition or decomposition of nonmetallic materials as weighed against
NOTE 3—Experience has shown that the use of bi-direction flow filters
the risk of flammability (refer to Guide G63 and ISO 15001.2). See
in components can lead to accumulation and re-release of contaminants
Appendix X1 and Appendix X2 for details.
(refer to Guide G88-05 Section 7.5.3.8 and EIGA Info 21/08).
1.3 This standard applies only to:
1.7 The values stated in inch-pound units are to be regarded
1.3.1 Oxygen pressure regulators used for medical and
as standard. The values given in parentheses are mathematical
emergency applications that are designed and fitted with CGA
conversions to SI units that are provided for information only
540inletconnections,CGA870pin-indexadapters(CGAV-1),
and are not considered standard.
or EN ISO 407 pin-index adapters.
1.3.2 Oxygen VIPRs used for medical and emergency
1.8 This standard does not purport to address all of the
applications that are designed to be permanently fitted to a
safety concerns, if any, associated with its use. It is the
medical gas cylinder.
responsibility of the user of this standard to establish appro-
1.4 This standard is a test standard not a design standard; priate safety, health, and environmental practices and deter-
Thisteststandardisnotintendedasasubstitutefortraditional mine the applicability of regulatory limitations prior to use.
1.9 This international standard was developed in accor-
dance with internationally recognized principles on standard-
1
This test method is under the jurisdiction of ASTM Committee G04 on
Compatibility and Sensitivity of Materials in Oxygen EnrichedAtmospheres and is ization established in the Decision on Principles for the
the direct responsibility of Subcommittee G04.01 on Test Methods.
Development of International Standards, Guides and Recom-
Current editi
...
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