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 the resistance to ignition tests in ISO 10524–1 for oxygen pressure regulators and ISO 10524–3 for oxygen VIPRs.
4.2.2 The pass/fail criteria for a pressure regulator are specified in the resistance to ignition tests in ISO 10524–1 for oxygen pressure regulators and ISO 10524–3 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 result in sustained combustion and burnout of the VIPR, while the VIPR is flowing oxygen in the patient-use direction.
4.3.2.1 The criterion for a valid test is either, (1) failure of 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 determined by visual inspection or mass determination. Although the intent and desired result is to provide sufficient energy to ignite the shut-off valve seat, ignition of the shut-off valve seat is not required for a valid test. See Rationale in Appendix X7.
4.3.2.2 Failure of the VIPR is defined as the breach of the pressurized VIPR component (burnout) and ejection of molten or burning metal or any parts, including the gauge, from the VIPR. 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.
4.3.3 There is no requirement that the oxygen pressure regulator or oxygen VIPR be functional after being subjected to the promoted ignition test.
Note 4: The criterion for both the pressure regulator and VIPR Phase 2 tests does not include evaluation of external hardware (such as plastic guards and bags) that could be subjected to a momentary ejection of flame through normal vent paths.
Scope
1.1 For the purpose of this test method, 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 test method 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 test method 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 test method 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.
1.5 This test method is also intended to aid those responsible for purchasing or using oxygen pressure regulators and VIPRs used for medical and emergency applications by ensuring that selected pressure regulators are tolerant of the ignition mechanisms that are normally active in oxygen systems.
1.6 This test method does not purport to address the ignition sensitivity and fault tolerance of an oxygen regulator or VIPR caused by contamination during field maintenance or use. Pressure regulator and VIPR designers and manufacturers should provide design safeguards to minimize the potential for contamination or its consequences (see Guide G88).
Note 3: Experience has shown that the use of bi-direction flow filters in components can lead to accumulation and re-release of contaminants (refer to Guide G88-05 7.5.3.8 and EIGA Info 21/08).
1.7 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.
1.8 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.9 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.
