ASTM G175-13

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 VIPR...

General Information

• Status: Historical
• Publication Date: 30-Sep-2013
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: G04 - Compatibility and Sensitivity of Materials in Oxygen Enriched Atmospheres
• Drafting Committee: G04.01 - Test Methods

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: G175 − 13
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
gasdeliveryinhospitalsandhomehealthcare,andemergencyapplications
868.2700 (a)]. Some of these oxygen pressure regulators are a
including, but not limited to, oxygen gas delivery by emergency person-
combination of a pressure regulator and cylinder valve. These
nel.
devices are often referred to as valve integrated pressure
1.5 This standard is also intended to aid those responsible
regulators, or VIPRs.
for purchasing or using oxygen pressure regulators and VIPRs
1.2 This standard provides an evaluation tool for determin-
used for medical and emergency applications by ensuring that
ing the ignition sensitivity and fault tolerance of oxygen
selected pressure regulators are tolerant of the ignition mecha-
pressureregulatorsandVIPRsusedformedicalandemergency
nisms that are normally active in oxygen systems.
applications. An ignition-sensitive pressure regulator or VIPR
1.6 This standard does not purport to address the ignition
is defined as having a high probability of ignition as evaluated
sensitivity and fault tolerance of an oxygen regulator or VIPR
by rapid pressurization testing (Phase 1). A fault-tolerant
caused by contamination during field maintenance or use.
pressure regulator or VIPR is defined as having a low conse-
Pressure regulator and VIPR designers and manufacturers
quence of ignition as evaluated by forced ignition testing
should provide design safeguards to minimize the potential for
(Phase 2).
contamination or its consequences (see Guide G88).
NOTE 1—It is essential that a risk assessment be carried out on
NOTE 3—Experience has shown that the use of bi-direction flow filters
breathing gas systems, especially concerning toxic product formation due
in components can lead to accumulation and re-release of contaminants
to ignition or decomposition of nonmetallic materials as weighed against
(refer to Guide G88-05 Section 7.5.3.8 and EIGA Info 21/08).
the risk of flammability (refer to Guide G63 and ISO 15001.2). See
1.7 The values stated in inch-pound units are to be regarded
Appendix X1 and Appendix X2 for details.
as standard. The values given in parentheses are mathematical
1.3 This standard applies only to:
conversions to SI units that are provided for information only
1.3.1 Oxygen pressure regulators used for medical and
and are not considered standard.
emergency applications that are designed and fitted with CGA
1.8 This standard does not purport to address all of the
540inletconnections,CGA870pin-indexadapters(CGAV-1),
safety concerns, if any, associated with its use. It is the
or EN ISO 407 pin-index adapters.
responsibility of the user of this standard to establish appro-
1.3.2 Oxygen VIPRs used for medical and emergency
priate safety and health practices and determine the applica-
applications that are designed to be permanently fitted to a
bility of regulatory limitations prior to use.
medical gas cylinder.
1.4 This standard is a test standard not a design standard;
2. Referenced Documents
Thisteststandardisnotintendedasasubstitutefortraditional
2
2.1 ASTM Standards:
1
This test method is under the jurisdiction of ASTM Committee G04 on
Compatibility and Sensitivity of Materials in Oxygen EnrichedAtmospheres and is
2
the direct responsibility of Subcommittee G04.01 on Test Methods. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Current edition approved Oct. 1, 2013. Published November 2013. Originally contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
published as PS127–00. Last published in 2011 as G175–03(2011). DOI: Standards volume information, refer to the standard’s Document Summary page on
10.1520/G0175-13. th
...

This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: G175 − 03 (Reapproved 2011) G175 − 13
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. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope
1.1 This standard describes a test method for evaluating the ignition sensitivity and fault tolerance of oxygen regulators used
for medical and emergency applications.
1.1 For the purpose of this standard, a pressure regulator is a device, regulator, also called a pressure-reducing valve, that is a
device intended for medical or emergency purposes and 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.
1.3 This standard applies only to oxygen regulators used for medical and emergency applications that are designed and fitted
with CGA 540 inlet connections or CGA 870 pin-index adapters (CGA V-1).
1.4 This standard provides an evaluation tool for determining the fault tolerance of oxygen regulators used for medical and
emergency applications. A fault tolerant regulator is defined as (1) having a low probability of ignition as evaluated by rapid
pressurization testing, and (2) having a low consequence of ignition as evaluated by forced ignition testing.
1.2 This standard is not a design standard; however, it can be used to aid designers in designing and evaluating the safe
performanceprovides an evaluation tool for determining the ignition sensitivity and fault tolerance capability of oxygen pressure
regulators and VIPRs used for medical and emergency applications (Guideapplications. An G128). 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 oxygen compatibility (refer to Guides G63
and G94) and 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 X2.1Appendix 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 VIPR should
consider the practices and materials in standards such as Guides G63, G88, G94, and G128, Practice G93, CGA E-18, CGA E-7,
ISO 15001, ISO 10524-1 and ISO 10524-3.
NOTE 2—Medical applications include, but are not limited to, oxygen gas delivery in hospitals and home healthcare, and emergency applications
including, but not limited to, oxygen gas delivery by emergency personnel.
1
This test method is under the jurisdiction of ASTM Committee G04 on Compatibility and Sensitivity of Materials in Oxygen Enriched Atmospheres and is the direct
responsibility of Subcommittee G04.01 on Test Methods.
Current edition approved April 1, 2011Oct. 1, 2013. Published April 2011November 2013. Originally published as PS 127 – 00. Last published in 2011 as
B175 – 03.G175 – 03(2011). DOI: 10.1520/G0175-03R11.10.1520/G0175-13.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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G175 − 13
1.5 This standard is also usedintended to aid those responsible for
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