1.1 就本试验方法而言，压力调节器，也称为减压阀，是一种用于医疗或应急目的的装置，用于将医疗或应急气体压力从高可变压力转换为较低、更恒定的工作压力[21 CFR 868.2700（a）]。其中一些氧气压力调节器是压力调节器和气瓶阀的组合。这些装置通常被称为阀门集成式压力调节器或VIPR。 1.2 该测试方法提供了一种评估工具，用于确定用于医疗和应急应用的氧气压力调节器和VIPR的点火灵敏度和容错性。 通过快速加压测试（第1阶段）评估，点火敏感压力调节器或VIPR被定义为具有高点火概率。容错压力调节器或VIPR被定义为通过强制点火测试（第2阶段）评估具有较低的点火后果。 注1: 必须对呼吸气体系统进行风险评估，尤其是对非金属材料的点燃或分解导致的有毒产品形成进行风险评估（以可燃性风险为衡量标准）（参考指南 G63 和ISO 15001.2）。看见 附录X1 和 附录X2 详细信息。 1.3 此测试方法仅适用于: 1.3.1 用于医疗和应急应用的氧气压力调节器，其设计和安装有CGA 540入口连接、CGA 870针分度适配器（CGA V-1）或EN ISO 407针分度适配器。 1.3.2 用于医疗和紧急应用的氧气VIPR，设计为永久安装在医用气瓶上。 1.4 此测试方法是一种测试标准，而非设计标准； 本试验标准并非用于替代氧气瓶阀门、压力调节器和VIPR的传统设计要求。精心设计的压力调节器或VIPR应考虑指南等标准中的实践和材料 G63 , G88 , G94 和 G128 实践 G93 ，CGA E-18，CGA E-7，ISO 15001，ISO 10524-1和ISO 10524-3 . 注2: 医疗应用包括但不限于医院和家庭医疗中的氧气输送，以及紧急应用，包括但不局限于急救人员的氧气输送。 1.5 该测试方法还旨在帮助那些负责购买或使用氧气压力调节器和用于医疗和紧急应用的VIPR的人，确保所选的压力调节器能够耐受氧气系统中通常活跃的点火机制。 1.6 本试验方法并不旨在解决现场维护或使用过程中污染引起的氧气调节器或VIPR的点火敏感性和容错性问题。 压力调节器和VIPR的设计者和制造商应提供设计保护措施，以最大限度地减少污染或其后果的可能性（见指南 G88 ). 注3: 经验表明，在部件中使用双向流过滤器可能会导致污染物的积聚和重新释放（请参阅指南 G88 -05 7.5.3.8和EIGA信息21/08）。 1.7 以英寸磅为单位的数值应视为标准。括号中给出的值是国际单位制的数学转换，仅供参考，不被视为标准。 1.8 本标准并不旨在解决与其使用相关的所有安全问题（如有）。 本标准的使用者有责任在使用前制定适当的安全、健康和环境实践，并确定监管限制的适用性。 1.9 本国际标准是根据世界贸易组织技术性贸易壁垒委员会发布的《关于制定国际标准、指南和建议的原则的决定》中确立的国际公认的标准化原则制定的。 ====意义和用途====== 4.1 该测试方法包括两个阶段，用于评估用于医疗和应急应用的氧气压力调节器的点火灵敏度和容错性。 4.2 第1阶段:氧气压力冲击试验-- 本测试阶段的目的是确定氧气压力冲击产生的热量或温度是否会导致压力调节器内部零件烧坏或可见的热损伤。 4.2.1 有效试验的标准在ISO 10524-1中对氧气压力调节器和ISO 10524-3中对氧气VIPR的耐燃性试验中进行了规定。 4.2.2 压力调节器的合格/不合格标准在ISO 10524-1中氧气压力调节器和ISO 10524-3中氧气VIPR的耐燃性试验中有规定。 4.3 第2阶段:促进点火试验-- 4.3.1 氧气压力调节器-- 该测试阶段的目的是确定压力调节器入口过滤器上游的点火事件是否会导致压力调节器持续燃烧和烧坏。 4.3.1.1 有效测试的标准是( 1. )压力调节器故障，如中所定义 4.3.1.2 或 2. )如果压力调节器没有发生故障，则消耗至少90%的通过目视检查或质量测定确定的点火药丸。 4.3.1.2 压力调节器的故障被定义为压力调节器部件破裂（烧坏），可能包括CGA 870密封圈，以及从压力调节器喷出熔融或燃烧的金属或任何零件，包括压力表。 看见 附录X6 用压力表测试调压器和VIPR。然而，通过正常排气路径瞬间（小于1秒）喷出火焰，产生的火花看起来与砂轮上金属产生的火花相似，是可以接受的，不构成故障。 4.3.2 氧气VIPR-- 本测试的目的是确定当VIPR在患者使用方向上流动氧气时，关闭阀上游或关闭阀内的点火事件是否会导致VIPR的持续燃烧和烧坏。 4.3.2.1 有效测试的标准是， 1. 中定义的VIPR故障 4.3.2.2 或 2. 如果VIPR没有失效，则消耗至少90%的通过目视检查或质量测定确定的点火药丸。 尽管目的和期望的结果是提供足够的能量来点燃截止阀座，但有效测试不需要点燃截止阀座。参见中的基本原理 附录X7 . 4.3.2.2 VIPR的故障定义为加压VIPR部件破裂（烧坏），熔融或燃烧的金属或任何部件（包括仪表）从VIPR喷出。看见 附录X6 用压力表测试调压器和VIPR。然而，通过正常排气路径瞬间（小于1秒）喷出火焰，产生的火花看起来与砂轮上金属产生的火花相似，是可以接受的，不构成故障。 4.3.3 不要求氧气压力调节器或氧气VIPR在经过促进点火试验后发挥作用。 注4: 压力调节器和VIPR第2阶段试验的标准不包括外部硬件（如塑料防护装置和袋子）的评估，这些硬件可能会通过正常通风路径瞬间喷出火焰。

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. ====== 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.