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作废 ASTM PS127-00
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Standard Test Method for Evaluating the Ignition Sensitivity and Fault Tolerance of Oxygen Regulators Used for Medical and Emergency Applications (Withdrawn 2003) 评估用于医疗和紧急应用的氧调节剂的点火灵敏度和容错度的标准测试方法(2003年)
发布日期: 2000-11-10
废止日期: 2003-07-08
1.1本标准描述了用于评估医疗和紧急应用中氧气调节器的点火灵敏度和容错性的测试方法。 1.2就本标准而言,压力调节器是一种装置,也称为减压阀,用于医疗或应急目的,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)]。 1.3本标准仅适用于用于医疗和紧急应用的氧气调节器,其设计和安装有CGA 870针索引适配器和CGA 540入口连接(CGA V-1)。 注1——尽管本标准仅适用于用于医疗或紧急应用的氧气调节器,但也可适用于本范围以外的其他类型的氧气调节器,由具有管辖权的机构酌情决定。 1.4本标准提供了一种评估工具,用于确定用于医疗和紧急应用的氧气调节器的容错性。 容错调节器定义为 1) 通过快速增压测试评估的点火概率较低,以及 2) 通过强制点火测试评估,点火后果较低。 1.5本标准不是设计标准;然而,它可以帮助设计者设计和评估用于医疗和紧急应用的氧气调节器的安全性能和容错能力(G 128)。 注2——必须对呼吸气体系统进行风险评估,特别是关于氧气兼容性(参考ASTM G 63和G 94)和由于非金属材料的点火或分解而形成的有毒产品,与易燃性风险进行权衡(参考ISO 15001)。 2). 详见附录X1和附录X2.1。 1.6本标准还用于帮助负责购买或使用用于医疗和应急应用的氧气调节器的人员,确保所选调节器能够耐受氧气系统中通常活跃的点火机制。 1.7本标准无意解决现场维护期间由污染引起的氧气调节器的点火灵敏度和容错性。调节器设计者和制造商应提供设计保障措施,以最大限度地减少污染的可能性或其后果(G 88)。 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。
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. 1.2 For the purpose of this standard, a pressure regulator is a device, also called a pressure-reducing valve, that is 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)]. 1.3 This standard applies only to oxygen regulators used for medical and emergency applications that are designed and fitted with CGA 870 pin-index adapters and CGA 540 inlet connections (CGA V-1). Note 1--Although this standard applies only to oxygen regulators used for medical or emergency applications, it may also apply to other types of oxygen regulators outside of this scope, at the discretion of the authority having jurisdiction. 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. 1.5 This standard is not a design standard; however, it can be used to aid designers in designing and evaluating the safe performance and fault tolerance capability of oxygen regulators used for medical and emergency applications (G 128). Note 2--It is essential that a risk assessment be carried out on breathing gas systems, especially concerning oxygen compatibility (refer to ASTM G 63 and G 94) and toxic product formation due to ignition or decomposition of nonmetallic materials as weighed against the risk of flammability (refer to ISO 15001.2). See Appendix X1 and Appendix X2.1 for details. 1.6 This standard is also used to aid those responsible for purchasing or using oxygen regulators used for medical and emergency applications in ensuring that selected regulators are tolerant of the ignition mechanisms that are normally active in oxygen systems. 1.7 This standard does not purport to address the ignition sensitivity and fault tolerance of an oxygen regulator caused by contamination during field maintenance. Regulator designers and manufacturers should provide design safeguards to minimize the potential for contamination or its consequences (G 88). 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.
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