| ASTM G175-13 Standard Test Method for Evaluating the Ignition Sensitivity and Fault Tolerance of Oxygen Regulators Used for Medical and Emergency Applications |
| Recognition Date | 2014-07-09 |
| Recognition List | 036 |
| Recognition Number | 1-99 |
| Extent | Complete standard |
| Standards Orgs | ASTM ASTM International http://www.astm.org/ |
| STG | Anesthesiology |
| FDA Tech | Amy Levelle FDA/OMPT/CDRH/ODE/DAGID/RPDB/ 301-796-6963 amy.levelle@fda.hhs.gov |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
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).
| Regulation Number | Device Name | Device Class | Product Code |
| §868.5905 | Conserver, Oxygen | Class 2 | NFB |
| §868.2700 | Regulator, Pressure, Gas Cylinder | Class 1 | CAN |
| There is no relevant guidance developed at this time. |