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ASTM G 175 : 2013 : REDLINE

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Standard Test Method for Evaluating the Ignition Sensitivity and Fault Tolerance of Oxygen Pressure Regulators Used for Medical and Emergency Applications

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English

Published date

01-10-2013

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CONTAINED IN VOL. 14.04, 2015 Defines an evaluation tool for determining the ignition sensitivity and fault tolerance of oxygen pressure regulators and VIPRs used for medical and emergency applications.

Committee
G 04
DevelopmentNote
Supersedes ASTM G 159. (10/2005)
DocumentType
Redline
Pages
23
PublisherName
American Society for Testing and Materials
Status
Current

1.1For 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.

1.2This 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 1It 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.

1.3This 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.

1.3.2Oxygen VIPRs used for medical and emergency applications that are designed to be permanently fitted to a medical gas cylinder.

1.4This 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 2Medical 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.

1.5This 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.

1.6This 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 3Experience 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).

1.7The 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.

1.8This 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.

04/30084857 DC : DRAFT JUN 2004 BS EN ISO 10524-1 - PRESSURE REGULATORS FOR USE WITH MEDICAL GAS SYSTEMS - PART 1: PRESSURE REGULATORS AND PRESSURE REGULATORS WITH FLOW-METERING DEVICES
17/30303091 DC : 0 BS EN ISO 10524-2 - PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 2: MANIFOLD AND LINE PRESSURE REGULATORS
CSA Z10524-1 : 2012 PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 1: PRESSURE REGULATORS AND PRESSURE REGULATORS WITH FLOW-METERING DEVICES
17/30303094 DC : 0 BS EN ISO 10524-3 - PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 3: PRESSURE REGULATORS INTEGRATED WITH CYLINDER VALVES
I.S. EN ISO 10524-3:2006 PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 3: PRESSURE REGULATORS INTEGRATED WITH CYLINDER VALVES (ISO 10524-3:2005)
ASTM G 88 : 2013 : REDLINE Standard Guide for Designing Systems for Oxygen Service
ISO 10524-3:2005 Pressure regulators for use with medical gases Part 3: Pressure regulators integrated with cylinder valves
BS EN ISO 15001:2011 Anaesthetic and respiratory equipment. Compatibility with oxygen
DIN EN ISO 10524-2:2006-07 PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 2: MANIFOLD AND LINE PRESSURE REGULATORS
ASTM G 74 : 2013 : REDLINE Standard Test Method for Ignition Sensitivity of Nonmetallic Materials and Components by Gaseous Fluid Impact
CSA Z10524-3 : 2012 : INC : AMD 1 : 2017 : R201700 PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 3: PRESSURE REGULATORS INTEGRATED WITH CYLINDER VALVES
17/30311331 DC : 0 BS EN ISO 10524-1 - PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 1: PRESSURE REGULATORS AND PRESSURE REGULATORS WITH FLOW-METERING DEVICES
BS EN ISO 10524-1:2006 Pressure regulators for use with medical gases Pressure regulators and pressure regulators with flow-metering devices
UNI EN ISO 10524-3 : 2013 PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 3: PRESSURE REGULATORS INTEGRATED WITH CYLINDER VALVES
EN ISO 10524-2:2006 Pressure regulators for use with medical gases - Part 2: Manifold and line pressure regulators (ISO 10524-2:2005)
I.S. EN ISO 15001:2011 ANAESTHETIC AND RESPIRATORY EQUIPMENT - COMPATIBILITY WITH OXYGEN (ISO 15001:2010)
UNI EN ISO 15001 : 2012 ANAESTHETIC AND RESPIRATORY EQUIPMENT - COMPATIBILITY WITH OXYGEN
CSA Z10524-2 : 2012 PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 2: MANIFOLD AND LINE PRESSURE REGULATORS
CSA Z10524-1 : 2012 : R2017 PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 1: PRESSURE REGULATORS AND PRESSURE REGULATORS WITH FLOW-METERING DEVICES
CSA Z10524-2 : 2012 : R2017 PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 2: MANIFOLD AND LINE PRESSURE REGULATORS
ASTM G 128/G128M : 2015 : REDLINE Standard Guide for Control of Hazards and Risks in Oxygen Enriched Systems
I.S. EN ISO 10524-1:2006 PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 1: PRESSURE REGULATORS AND PRESSURE REGULATORS WITH FLOW-METERING DEVICES
DIN EN ISO 10524-3:2013-06 PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 3: PRESSURE REGULATORS INTEGRATED WITH CYLINDER VALVES (ISO 10524-3:2005 + AMD 1:2013)
EN ISO 10524-1:2006 Pressure regulators for use with medical gases - Part 1: Pressure regulators and pressure regulators with flow-metering devices (ISO 10524-1:2006)
BS EN ISO 10524-2:2006 Pressure regulators for use with medical gases Manifold and line pressure regulators
DIN EN ISO 15001:2012-06 Anaesthetic and respiratory equipment - Compatibility with oxygen (ISO 15001:2010)
06/30116855 DC : 0 BS ISO 10524-4 - PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 4: LOW-PRESSURE REGULATORS INTENDED FOR INCORPORATION INTO MEDICAL EQUIPMENT
CSA Z15001 : 2012 ANAESTHETIC AND RESPIRATORY EQUIPMENT - COMPATIBILITY WITH OXYGEN
CAN/CSA-Z15001:12 (R2017) Anaesthetic and respiratory equipment - Compatibility with oxygen (Adopted ISO 15001:2010, second edition, 2010-06-01, with Canadian deviations)
BS EN ISO 10524-3 : 2006 PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 3: PRESSURE REGULATORS INTEGRATED WITH CYLINDER VALVES
ISO 10524-2:2018 Pressure regulators for use with medical gases — Part 2: Manifold and line pressure regulators
ISO 15001:2010 Anaesthetic and respiratory equipment Compatibility with oxygen
EN ISO 15001:2011 Anaesthetic and respiratory equipment - Compatibility with oxygen (ISO 15001:2010)
CSA Z10524-3 : 2012 PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 3: PRESSURE REGULATORS INTEGRATED WITH CYLINDER VALVES
CSA Z10524-3 : 2012 : R2017 PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 3: PRESSURE REGULATORS INTEGRATED WITH CYLINDER VALVES
ISO 10524-1:2018 Pressure regulators for use with medical gases — Part 1: Pressure regulators and pressure regulators with flow-metering devices
I.S. EN ISO 10524-2:2006 PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 2: MANIFOLD AND LINE PRESSURE REGULATORS
UNE-EN ISO 15001:2012 Anaesthetic and respiratory equipment - Compatibility with oxygen (ISO 15001:2010)

CFR 21(PTS1300-END) : 0 FOOD AND DRUGS
ASTM D 618 : 2013 : REDLINE Standard Practice for Conditioning Plastics for Testing
CGA V 1 : 2013 STANDARD FOR COMPRESSED GAS CYLINDER VALVE OUTLET AND INLET CONNECTIONS
CGA E 18 : 2015 MEDICAL GAS VALVE INTEGRATED PRESSURE REGULATORS
ISO 15001:2010 Anaesthetic and respiratory equipment Compatibility with oxygen
ASTM G 88 : 2013 : REDLINE Standard Guide for Designing Systems for Oxygen Service
ASTM D 6779 : 2017 : REDLINE Standard Classification System for and Basis of Specification for Polyamide Molding and Extrusion Materials (PA)
CFR 21(PTS800-1299) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299
ISO 10524-3:2005 Pressure regulators for use with medical gases Part 3: Pressure regulators integrated with cylinder valves
CGA G 4 : 2015 OXYGEN
ASTM D 4066 : 2013 Standard Classification System for Nylon Injection and Extrusion Materials (PA)
CGA V 14 : 2011 PERFORMANCE STANDARD FOR SEALING GASKETS USED ON CGA 870 CONNECTIONS FOR MEDICAL OXYGEN SERVICE
CGA E 4 : 2016 STANDARD FOR GAS PRESSURE REGULATORS
ASTM G 63 : 2015 : REDLINE Standard Guide for Evaluating Nonmetallic Materials for Oxygen Service
CGA E 7 : 2013 MEDICAL GAS PRESSURE REGULATORS, FLOWMETERS, AND ORIFICE FLOW SELECTORS
ISO 10524-1:2006 Pressure regulators for use with medical gases Part 1: Pressure regulators and pressure regulators with flow-metering devices
CGA G 4.1 : 2009 CLEANING EQUIPMENT FOR OXYGEN SERVICE

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