ASTM G175-2013 Standard Test Method for Evaluating the Ignition Sensitivity and Fault Tolerance of Oxygen Pressure Regulators Used for Medical and Emergency Applications《评定医疗和紧急设施用.pdf

1、Designation: G175 13Standard Test Method forEvaluating the Ignition Sensitivity and Fault Tolerance ofOxygen Pressure Regulators Used for Medical andEmergency Applications1This standard is issued under the fixed designation G175; the number immediately following the designation indicates the year of

2、original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 For the purpose of this standard, a pressure regulator,also

3、 called a pressure-reducing valve, is a device intended formedical or emergency purposes that is used to convert amedical or emergency gas pressure from a high, variablepressure to a lower, more constant working pressure 21 CFR868.2700 (a). Some of these oxygen pressure regulators are acombination o

4、f a pressure regulator and cylinder valve. Thesedevices are often referred to as valve integrated pressureregulators, or VIPRs.1.2 This standard provides an evaluation tool for determin-ing the ignition sensitivity and fault tolerance of oxygenpressure regulators and VIPRs used for medical and emerg

5、encyapplications. An ignition-sensitive pressure regulator or VIPRis defined as having a high probability of ignition as evaluatedby rapid pressurization testing (Phase 1). A fault-tolerantpressure regulator or VIPR is defined as having a low conse-quence of ignition as evaluated by forced ignition

6、testing(Phase 2).NOTE 1It is essential that a risk assessment be carried out onbreathing gas systems, especially concerning toxic product formation dueto ignition or decomposition of nonmetallic materials as weighed againstthe risk of flammability (refer to Guide G63 and ISO 15001.2). SeeAppendix X1

7、 and Appendix X2 for details.1.3 This standard applies only to:1.3.1 Oxygen pressure regulators used for medical andemergency applications that are designed and fitted with CGA540 inlet connections, CGA870 pin-index adapters (CGAV-1),or EN ISO 407 pin-index adapters.1.3.2 Oxygen VIPRs used for medic

8、al and emergencyapplications that are designed to be permanently fitted to amedical gas cylinder.1.4 This standard is a test standard not a design standard;This test standard is not intended as a substitute for traditionaldesign requirements for oxygen cylinder valves, pressureregulators and VIPRs.

9、A well-designed pressure regulator orVIPR should consider the practices and materials in standardssuch as Guides G63, G88, G94, and G128, Practice G93, CGAE-18, CGA E-7, ISO 15001, ISO 10524-1 and ISO 10524-3.NOTE 2Medical applications include, but are not limited to, oxygengas delivery in hospitals

10、 and home healthcare, and emergency applicationsincluding, but not limited to, oxygen gas delivery by emergency person-nel.1.5 This standard is also intended to aid those responsiblefor purchasing or using oxygen pressure regulators and VIPRsused for medical and emergency applications by ensuring th

11、atselected pressure regulators are tolerant of the ignition mecha-nisms that are normally active in oxygen systems.1.6 This standard does not purport to address the ignitionsensitivity and fault tolerance of an oxygen regulator or VIPRcaused by contamination during field maintenance or use.Pressure

12、regulator and VIPR designers and manufacturersshould provide design safeguards to minimize the potential forcontamination or its consequences (see Guide G88).NOTE 3Experience has shown that the use of bi-direction flow filtersin components can lead to accumulation and re-release of contaminants(refe

13、r to Guide G88-05 Section 7.5.3.8 and EIGA Info 21/08).1.7 The values stated in inch-pound units are to be regardedas standard. The values given in parentheses are mathematicalconversions to SI units that are provided for information onlyand are not considered standard.1.8 This standard does not pur

14、port to address all of thesafety concerns, if any, associated with its use. It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2. Referenced Documents2.1 ASTM Standards:21T

15、his test method is under the jurisdiction of ASTM Committee G04 onCompatibility and Sensitivity of Materials in Oxygen Enriched Atmospheres and isthe direct responsibility of Subcommittee G04.01 on Test Methods.Current edition approved Oct. 1, 2013. Published November 2013. Originallypublished as PS

16、 127 00. Last published in 2011 as G175 03(2011). DOI:10.1520/G0175-13.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe AST

17、M website.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States1G63 Guide for Evaluating Nonmetallic Materials for Oxy-gen ServiceG88 Guide for Designing Systems for Oxygen ServiceG93 Practice for Cleaning Methods and Cleanliness Levelsfor

18、Material and Equipment Used in Oxygen-EnrichedEnvironmentsG94 Guide for Evaluating Metals for Oxygen ServiceG128 Guide for Control of Hazards and Risks in OxygenEnriched SystemsD618 Practice for Conditioning Plastics for TestingD4066 Classification System for Nylon Injection and Extru-sion Materials

19、 (PA)D6779 Classification System for and Basis of Specificationfor Polyamide Molding and Extrusion Materials (PA)2.2 Other ASTM Documents:2Manual 36 Safe Use of Oxygen and Oxygen SystemsSmith, S. R., and Stoltzfus, J. M., “Preliminary Results ofASTM G175 Interlaboratory Studies,” Flammability andSen

20、sitivity of Materials in Oxygen-Enriched Atmospheres:Tenth Volume, ASTM STP 1454, T. A. Steinberg, H. D.Beeson, and B. E. Newton, Eds., ASTM International,West Conshohocken, PA, 2003.Smith, S. R., and Stoltzfus, J. M., “ASTM G175 Interlabo-ratory Study on Forced Ignition Testing,” Journal ofASTM Int

21、ernational, Vol. 3, No. 7, Paper ID JAI13542,pp. 314-318.2.3 Compressed Gas Association (CGA) Standards:3CGA E-4 Standard for Gas Pressure RegulatorsCGA E-7 Standard for Medical Pressure RegulatorsCGA E-18 Medical Gas Valve Integrated Pressure Regula-torsCGA G-4 OxygenCGA G-4.1 Cleaning Equipment fo

22、r Oxygen ServiceCGA V-1 American National/Compressed Gas AssociationStandard for Compressed Gas Cylinder Valve Outlet andInlet ConnectionsCGA V-14 Performance Standard for Sealing Gaskets Usedon CGA 870 Connections for Medical Oxygen Service2.4 United States Pharmacopeial Convention Standard:4USP24N

23、F19Oxygen monograph2.5 Federal Regulation:521 CFR 868.2700 (a) Pressure regulator2.6 ISO Standards:6ISO 10524-1 Pressure regulators for use with medical gases Part 1: Pressure regulators and pressure regulators withflow-metering devicesISO 10524-3 Pressure regulators for use with medical gases Part

24、3: Pressure regulators integrated with cylindervalvesISO 15001 Anaesthetic and respiratory equipment Com-patibility with oxygen2.7 European Industrial Gas Association Documents:7EIGA Info 21/08 Cylinder ValvesDesign Considerations3. Summary of Test Method3.1 This test method comprises two phases. A

25、pressureregulator or VIPR must pass both phases in order to beconsidered ignition-resistant and fault-tolerant.3.2 Phase 1: Oxygen Pressure Shock TestIn this testphase, the ignition sensitivity of the pressure regulator designis evaluated by subjecting the pressure regulator or VIPR toheat from oxyg

26、en pressure shocks. The test is performedaccording to ISO 105241 Section 6.6 for oxygen regulators,which is similar to CGA E-7 and ISO 105243 Section 6.6 foroxygen VIPRs.3.3 Phase 2: Promoted Ignition TestThe Phase 1 compo-nent test system is used for Phase 2 to pressure shock apressure regulator or

27、 VIPR so that an ignition pill is kindled toinitiate combustion within the pressure regulator or VIPR. Theignition source is representative of severe, but realistic, serviceconditions.3.3.1 Oxygen Pressure RegulatorIn this test phase, andfor this component type, fault tolerance is evaluated bysubjec

28、ting the pressure regulator to the forced application of apositive ignition source at the pressure regulator inlet tosimulate cylinder valve seat ignition and particle impactevents.3.3.2 Oxygen VIPRIn this test phase and for this compo-nent type, fault tolerance is evaluated by subjecting the VIPRto

29、 the forced application of a positive ignition source at thecylinder connection port to simulate a shut-off valve seatignition and particle impact events in the use (not cylinderfilling mode) configuration.4. Significance and Use4.1 This test method comprises two phases and is used toevaluate the ig

30、nition sensitivity and fault tolerance of oxygenpressure regulators used for medical and emergency applica-tions.4.2 Phase 1: Oxygen Pressure Shock TestThe objective ofthis test phase is to determine whether the heat or temperaturefrom oxygen pressure shocks will result in burnout or visibleheat dam

31、age to the internal parts of the pressure regulator.4.2.1 The criteria for a valid test are specified in ISO105241, Section 6.6 for oxygen pressure regulators and ISO105243, Section 6.6 for oxygen VIPRs.4.2.2 The pass/fail criteria for a pressure regulator arespecified in ISO 105241, Section 6.6 for

32、 oxygen pressureregulators and ISO 105243, Section 6.6 for oxygen VIPRs.4.3 Phase 2: Promoted Ignition Test4.3.1 Oxygen Pressure RegulatorThe objective of this testphase is to determine if an ignition event upstream of the3Available from Compressed Gas Association (CGA), 4221 Walney Rd., 5thFloor, C

33、hantilly, VA 20151-2923, http:/.4Available from U.S. Pharmacopeia (USP), 12601 Twinbrook Pkwy., Rockville,MD 20852.5Available from U.S. Government Printing Office Superintendent of Documents,732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401, http:/www.access.gpo.gov.6Available from Intern

34、ational Organization for Standardization (ISO), 1, ch. dela Voie-Creuse, Case postale 56, CH-1211, Geneva 20, Switzerland, http:/www.iso.ch.7Available from European Industrial Gas Association (EIGA), AISBL Avenuedes Arts, 3-5-b-1210 Brussels, Belgium, https:/www.eiga.eu/.G175 132pressure regulator i

35、nlet filter will result in sustained combus-tion and burnout of the pressure regulator.4.3.1.1 The criterion for a valid test is either, (1) failure ofthe pressure regulator, as defined in 4.3.1.2,or(2)ifthepressure regulator does not fail, consumption of at least 90 %of the ignition pill as determi

36、ned by visual inspection or massdetermination.4.3.1.2 Failure of the pressure regulator is defined as thebreach of the pressurized regulator component (burnout),which may include the CGA 870 seal ring, and ejection ofmolten or burning metal or any parts, including the gauge, fromthe pressure regulat

37、or. See Appendix X6 Testing PressureRegulators 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 agrinding wheel, is acceptable and does not constitute a failure.4.3.2 Oxygen VIPRThe objec

38、tive of this test is to deter-mine if an ignition event upstream of the shut-off valve orwithin the shut-off valve will result in sustained combustionand burnout of the VIPR, while the VIPR is flowing oxygen inthe patient-use direction.4.3.2.1 The criterion for a valid test is either, (1) failure of

39、the VIPR as defined in 4.3.2.2,or(2) if the VIPR does not fail,consumption of at least 90 % of the ignition pill as determinedby visual inspection or mass determination.Although the intentand desired result is to provide sufficient energy to ignite theshut-off valve seat, ignition of the shut-off va

40、lve seat is notrequired for a valid test. See Rationale in Appendix X7.4.3.2.2 Failure of the VIPR is defined as the breach of thepressurized VIPR component (burnout) and ejection of moltenor burning metal or any parts, including the gauge, from theVIPR. See Appendix X6 Testing Pressure Regulators a

41、ndVIPRs with Gauges. However, momentary (less than 1 s)ejection of flame through normal vent paths, with sparks thatlook similar to those from metal applied to a grinding wheel, isacceptable and does not constitute a failure.4.3.3 There is no requirement that the oxygen pressureregulator or oxygen V

42、IPR be functional after being subjectedto the promoted ignition test.NOTE 4The criterion for both the pressure regulator and VIPR Phase2 tests does not include evaluation of external hardware (such as plasticguards and bags) that could be subjected to a momentary ejection of flamethrough normal vent

43、 paths.5. Apparatus5.1 Both phases of this test shall be performed in a testsystem as specified by ISO 10524-1 and ISO 10524-3.5.2 Fig. 1 depicts a schematic representation of a typicalpneumatic impact test system that complies with ISO 10524-1and ISO 10524-3.5.3 The ambient temperature surrounding

44、the pressure regu-lator or VIPR must be 70 6 9F (21 6 5C) for both phases ofthis test. For Phase 2 testing, the initial test gas temperatureshall be 140 6 5.4F (60 6 3C).6. Materials6.1 For both phases of testing, the pressure regulator orVIPR shall be functional and in its normal delivery condition

45、and shall be tested as supplied by the manufacturer. For furtherinformation, see Section 8.2.2.1 for pressure regulators andSection 8.2.3.1 for VIPRs. If a prototype or nonproduction unitis used to qualify the design, it shall be manufactured usingdesign tolerances, materials, and processes consiste

46、nt with aproduction unit. A possible total of eight pressure regulators orVIPRs will be tested: three in Phase 1 and five in Phase 2. If thetest articles from Phase 1 are undamaged, they may bereassembled and used for Phase 2.6.2 Ignition Pill Manufacture and AssemblyFollow thesesteps to manufacture

47、 and assemble the ignition pill used forPhase 2 testing. Use the materials listed in Table 1 tomanufacture the ignition pills. The total required energy for theFIG. 1 Typical Test System ConfigurationG175 133ignition pill is 500 6 50 cal (2093 6 209 J) for pressureregulators and 200 6 20 cal (837 6

48、84 J) for VIPRs. SeeAppendix X7, Development of 200 Cal Ignition Pill for VIPRs.The ignition pill casing consists of a cup and layers of sheeting.The cup and sheeting shall be constructed of polyamide (PA66or PA6). Both the PA66 and PA6 shall be procured using theappropriate classification per Class

49、ifications D4066,orD6779,or both. This classification shall be documented and made partof the quality record.NOTE 5The ignition pill was developed to simulate both particleimpact events and cylinder valve seat ignition. Particle impact events aresimulated by iron/aluminum powder within the ignition pill. Nonmetallicpromoters within the ignition pill simulate cylinder valve seat ignition forpressure regulators. The nonmetallic promoters are also used to bind andkindle ignition of the metallic powder and the shut-off valve seat for