1.1就本标准而言，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钢瓶阀的组合。这些装置通常被称为阀门集成压力调节器或VIPRs。 1.2本标准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。根据快速增压测试（第1阶段）评估，点火敏感压力调节器或VIPR被定义为具有较高的点火概率。 容错压力调节器或VIPR被定义为具有通过强制点火测试（第2阶段）评估的低点火后果。 注1 — 必须对呼吸气体系统进行风险评估，尤其是与易燃性风险相比，考虑到非金属材料的点燃或分解而形成的有毒产品（请参阅指南G63和ISO 15001.2）。看见 附录X1 和 附录X2 详细信息。 1.3本标准仅适用于: 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入口接头、CGA 870针索引适配器（CGA V-1）或EN ISO 407针索引适配器。 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本标准是测试标准，不是设计标准； 本试验标准无意替代氧气瓶阀门、压力调节器和VIPR的传统设计要求。设计良好的压力调节器或VIPR应考虑标准中的实践和材料，如指南G63、G88、G94和G128、实践G93、CGA E-18、CGA E-7、ISO 15001、ISO 10524-1和ISO 10524-3 . 注释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，包括但不限于急救人员的氧气输送。 1.5本标准还旨在通过确保选定的压力调节器能够承受氧气系统中通常活跃的点火机制，帮助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的人员。 1.6本标准无意解决现场维护或使用过程中因污染引起的氧气调节器或VIPR的点火灵敏度和容错性。压力调节器和VIPR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的可能性或其后果（见指南G88）。 附注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积聚和重新释放（请参阅指南G88-05第7.5.3.8节和EIGA信息21/08）。 1.7以英寸-磅为单位的数值应视为标准值。括号中给出的值是到国际单位制的数学转换，仅供参考，不被视为标准值。 1.8 本标准并非旨在解决与其使用相关的所有安全问题（如有）。 本标准的用户有责任在使用前制定适当的安全和健康实践，并确定监管限制的适用性。 ====意义和用途====== 4.1本试验方法包括两个阶段，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- 该测试阶段的目标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热损坏。 4.2.1有效试验的标准在ISO 10524-1第6.6节氧气压力调节器和ISO 10524-3第6.6节氧气VIPR中规定。 4.2.2 ISO 10524-1第6节规定了压力调节器的通过/失败标准。 6适用于氧气压力调节器，ISO 10524-3第6.6节适用于氧气VIPR。 4.3 第2阶段:促进点火测试- 4.3.1 氧气压力调节器- 该测试阶段的目标是确定调压器入口过滤器上游的点火事件是否会导致调压器持续燃烧和烧毁。 4.3.1.1有效试验的标准为:( 1. )压力调节器故障，定义见 4.3.1.2 ，或( 2. )如果压力调节器没有故障，则消耗至少90 % 通过目视检查或质量测定确定的点火药丸的质量。 4.3.1.2压力调节器故障被定义为压力调节器组件破裂（烧坏），可能包括CGA 870密封圈，以及熔化或燃烧的金属或任何零件（包括仪表）从压力调节器中喷出。 看见 附录X6 使用仪表测试压力调节器和VIPR。然而，通过正常通风路径瞬时（小于1秒）喷射火焰，火花看起来类似于施加在砂轮上的金属火花，这是可以接受的，并不构成故障。 4.3.2 氧气VIPR- 本试验的目的是确定当VIPR向患者使用方向流动氧气时，切断阀上游或切断阀内的点火事件是否会导致VIPR持续燃烧和烧毁。 4.3.2.1有效试验的标准为:， (1) 中定义的VIPR故障 4.3.2.2 或 (2) 如果VIPR没有失效，则通过目视检查或质量测定确定至少90%的点火药丸消耗量。虽然目的和预期结果是提供足够的能量来点燃关闭装置- 关闭阀座时，有效测试不需要点火关闭阀座。请参阅中的基本原理 附录X7 . 4.3.2.2振动防护装置的故障定义为加压振动防护装置部件破裂（烧坏）以及熔化或燃烧的金属或任何零件（包括仪表）从振动防护装置中喷出。看见 附录X6 使用仪表测试压力调节器和VIPR。然而，通过正常通风路径瞬时（小于1秒）喷射火焰，火花看起来类似于施加在砂轮上的金属火花，这是可以接受的，并不构成故障。 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能够正常工作。 附注4 — 压力调节器和VIPR第2阶段测试的标准不包括评估可能通过正常通风路径瞬时喷射火焰的外部硬件（如塑料防护罩和袋子）。

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 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 standard 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 standard 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 Section 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 and health practices and determine the applicability of regulatory limitations prior to use. ====== 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 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.