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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 036 Date of Entry 07/09/2014 
FR Recognition Number 1-99
Standard
ASTM G175-13 Standard Test Method for Evaluating the Ignition Sensitivity and Fault Tolerance of Oxygen Regulators Used for Medical and Emergency Applications
Scope/Abstract
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).
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§868.2700 Regulator, Pressure, Gas Cylinder Class 1 CAN
§868.5905 Conserver, Oxygen Class 2 NFB
FDA Technical Contact
 Amy Levelle
  FDA/OC/CDRH/OPEQ/OHTI/DHTIC/
  301-796-6963
  amy.levelle@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
Anesthesiology
*These are provided as examples and others may be applicable.
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