Significance and Use

This test method comprises two phases and is used to evaluate the ignition sensitivity and fault tolerance of oxygen regulators used for medical and emergency applications.

Phase 1: Oxygen Pressure Shock Test The objective of this test phase is to determine whether the heat from oxygen pressure shocks will result in burnout or visible heat damage to the internal parts of the regulator. Phase 1 is performed according to ISO 10524, Section 11.8.1.

The criteria for an acceptable test are specified in ISO 10524, Section 11.8.1.

The pass/fail criteria for a regulator are specified in ISO 10524, Section 11.8.1.

Phase 2: Regulator Inlet Promoted Ignition Test The objective of this test phase is to determine if an ignition event upstream of the regulator inlet filter will result in sustained combustion and burnout of the regulator.

The criterion for an acceptable test is either, ( 1 ) failure of the regulator, which is defined as the breach of the pressurized regulator component (burnout) and ejection of molten or burning metal or any internal parts from the regulator, or ( 2 ) if the regulator does not fail, consumption of at least 90 % of the ignition pill as determined by visual inspection or mass determination. Failure of the regulator at the seal ring does not constitute an acceptable test.

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.

1. Scope

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 540 inlet connections or CGA 870 pin-index adapters (CGA V-1).

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 (Guide G128 ).

Note 1It is essential that a risk assessment be carried out on breathing gas systems, especially concerning oxygen compatibility (refer to Guides G63 and G94 ) 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 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 or use. Regulator designers and manufacturers should provide design safeguards to minimize the potential for contamination or its consequences (Guide G88 ).

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.

2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.

ASTM Standards

G63 Guide for Evaluating Nonmetallic Materials for Oxygen Service

G88 Guide for Designing Systems for Oxygen Service

G93 Practice for Cleaning Methods and Cleanliness Levels for Material and Equipment Used in Oxygen-Enriched Environments

G94 Guide for Evaluating Metals for Oxygen Service

G128 Guide for Control of Hazards and Risks in Oxygen Enriched Systems

Compressed Gas Association (CGA) Standards

United States Pharmacopeial Convention Standard

Keywords

fault tolerance; forced ignition; ignition; ignition sensitivity; impact test; medical oxygen regulator; oxygen pressure shock test; oxygen regulator; promoted ignition; Emergency medical services (EMS); Fault tolerance; Ignition--medical equipment/systems/applications; Medical emergencies; Ignition sensitivity; Medical oxygen reguator; Oxygen pressure shock test; Oxygen service/systems; Tolerances--medical/laboratory equipment applications;

ICS Code

ICS Number Code 11.040.10 (Anaesthetic, respiratory and reanimation equipment)

DOI: 10.1520/G0175-03R11

ASTM International is a member of CrossRef.

ASTM G175