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Pressure regulators for use with medical gases - Part 1: Pressure regulators and pressure regulators with flow-metering devices
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Basic data | Standard ID | GB/T 45897.1-2025 (GB/T45897.1-2025) | | Description (Translated English) | Pressure regulators for use with medical gases - Part 1: Pressure regulators and pressure regulators with flow-metering devices | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | C46 | | Classification of International Standard | 11.040.10 | | Word Count Estimation | 30,368 | | Date of Issue | 2025-08-01 | | Date of Implementation | 2026-08-01 | | Issuing agency(ies) | State Administration for Market Regulation, Standardization Administration of China | GB/T 45897.1-2025: Pressure regulators for use with medical gases - Part 1: Pressure regulators and pressure regulators with flow-metering devices
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ICS 11.040.10
CCSC46
National Standard of the People's Republic of China
Medical gas pressure regulators Part 1.Pressure
Regulators and pressure regulators with flow meters
(ISO 10524-1.2018,MOD)
Released on August 1, 2025
Implementation on August 1, 2026
State Administration for Market Regulation
The National Standardization Administration issued
Table of Contents
Preface III
Introduction IV
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Naming 3
5 General Requirements 3
5.1 Security 3
5.2 Availability 4
5.3 Optional Structure 4
5.4 Materials 4
6 Design Requirements 4
6.1 General Principles 4
6.2 Cylinder pressure or cylinder capacity indicator 5
6.3 Integrated electrical equipment 5
6.4 Connector 5
6.5 *Outlet pressure requirement 6
6.6 Flow meter device 6
6.7 Flow Control and Display 6
6.8 Pressure regulating device 6
6.9 *Filter 7
6.10 *Pressure relief device 7
6.11 Leakage 7
6.12 Mechanical strength 7
6.13 *Flame retardant 8
6.14 Requirements for pressure regulators with flow meters 8
6.15 Requirements for pressure regulators with flow meters 9
6.16 Requirements for pressure regulators with fixed orifices 9
6.17 Durability 10
7 Assembly Requirements 10
7.1 * Cleanliness 10
7.2 Lubricant 10
7.3 Disassembly torque 10
8 Test methods for type tests 11
8.1 General test principles 11
8.2 Pilot Plan 11
8.3 Test method for outlet pressure 12
8.4 Test methods for pressure relief devices 14
8.5 Leakage test method 14
8.6 Test method for mechanical strength 15
8.7 Test methods for flame retardancy 15
8.8 Test method for flow accuracy of pressure regulator with flow meter or flow meter 16
8.9 Test method for flow stability of pressure regulators with flow meters or flow gauges 16
8.10 Test method for flow accuracy and stability of pressure regulators equipped with fixed orifices 16
8.11 Test method for flow setting torque and removal torque 16
8.12 Test method for durability of markings and color identification 16
8.13 * Test method for durability of flow selector device 16
8.14 Test method for durability of pressure regulator 17
9 Marking, color coding and packaging17
9.1 Mark 17
9.2 Color identification 18
9.3 Packaging 18
10 Information provided by the manufacturer18
Appendix A (Informative) Basic Principles 20
Reference 23
Preface
This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for standardization work Part 1.Structure and drafting rules for standardization documents"
Drafting.
This document is Part 1 of GB/T 45897 “Medical gas pressure regulators”. GB/T 45897 has been published in the following parts.
--- Part 1.Pressure regulators and pressure regulators with flow meters;
--- Part 2.Busbar pressure regulator and pipeline pressure regulator;
--- Part 3.Pressure regulators with integrated cylinder valves (VIPRs);
--- Part 4.Low pressure regulators.
This document is modified to adopt ISO 10524-1.2018 "Medical gas pressure regulators Part 1.Pressure regulators and flowmeters
Pressure Regulator.
The technical differences between this document and ISO 10524-1.2018 and their reasons are as follows.
--- Incorporate the contents of the nominal outlet pressure (p2) into the notes (see 6.5.1.2);
--- ISO 14971 has been replaced by the normative reference GB/T 42062 to adapt to my country's technical conditions (see 5.1);
--- ISO 15001 has been replaced by the normative reference GB/T 45899 to adapt to my country's technical conditions (see 5.1, 7.1);
--- EN837-1 is replaced by the normative reference GB/T 1226 to adapt to my country's technical conditions (see 6.2.2);
--- Replaced IEC 60601-1 with the normative reference GB 9706.1 to adapt to my country's technical conditions (see 6.3);
--- ISO 5145 is replaced by the normative reference GB/T 15383 to adapt to my country's technical conditions (see 6.4.1);
--- Replaced ISO 9170 (all parts) with the normative reference GB/T 45898.1 to adapt to my country's technical conditions (see
6.4.2.3);
--- Replaced ISO 10297 with the normative reference GB/T 15382-2021 to adapt to my country's technical conditions (see 8.1.2,
8.2, 8.7.1, 8.14);
--- The normative reference GB 50751 replaces ISO 32 to adapt to my country's technical conditions (see 9.1.1);
--- Deleted the term "mastoid joint" which was used only once in the text (see 3.10 of ISO 10524-1.2018).
The following editorial changes have been made to this document.
--- Incorporated the amendments to ISO 10524-1.2018/Amd1.2023, and the outer margins of the clauses involved are marked with vertical
Straight double lines (‖) are marked;
--- Deleted some notes related to regional or national standards;
--- Replaced ISO 15001 with the informative reference GB/T 45899-2025 (see 5.4.1, 5.4.2);
--- Replaced IEC 60529 with the informative reference GB/T 4208 (see 6.2.2.2);
--- Delete the subscripts of some gases in Table 4 and add relevant instructions (see 9.1.1);
--- Replaced ISO 7396-1 with the informative reference GB/T 44059.1 (see A.6.5, A.6.10);
--- Deleted the appendix "Reported regional and national differences in colour identification and terminology for medicinal gases" (see ISO 10524-1.
Appendix B of.2018).
Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents.
This document is proposed by the State Food and Drug Administration.
This document is under the jurisdiction of the National Technical Committee for Standardization of Anesthesia and Respiratory Equipment (SAC/TC116).
This document was drafted by. Shanghai Institute of Medical Device Inspection, Jierui Enterprise (Shanghai) Co., Ltd., Yuyao Jiahua Medical Device Co., Ltd.
company.
The main drafters of this document are Liu Shihai, Miao Lifeng, Zhou Jianhua, Wang Wei, Wang Yongyi, and Yu Hongyi.
introduction
GB/T 45897 "Medical gas pressure regulators" is intended to consist of four parts.
--- Part 1.Pressure regulators and pressure regulators with flow meters. The purpose is to specify the pressure regulators intended for patient treatment,
Pressure regulators for the management of medical gases and their mixtures for the treatment, diagnosis, evaluation and nursing of medical equipment or for the management of gases used to drive surgical instruments
Design, construction, type testing and marking requirements.
--- Part 2.Busbar pressure regulators and pipeline pressure regulators. The purpose is to specify the intended use in medical gas pipeline systems
Design, structure, type test and marking requirements for bus pressure regulators and pipeline pressure regulators.
--- Part 3.Pressure regulators with integrated cylinder valves (VIPRs). The purpose is to specify the pressure regulators intended for use in the treatment, management, diagnosis and treatment of patients.
A device with an integrated gas cylinder valve pressure regulator for the management of medical gases or gases used to drive surgical instruments for diagnostic assessment and care
Design, type testing and marking requirements.
--- Part 4.Low pressure regulators. The purpose is to specify the low pressure regulators for oxygen, nitrous oxide (laughing gas), medical air, helium, dioxygen
Carbon dioxide, xenon and specific mixtures of the above gases, air for driving surgical instruments, nitrogen and oxygen-enriched air for driving surgical instruments
Specification for low-pressure regulators for use in conjunction with this standard for patient treatment, management, diagnostic evaluation, and care.
Pressure regulators are used to reduce cylinder pressure to a lower pressure suitable for use in medical devices or for delivering gas directly to patients.
These functions involve a wide range of pressures and flows at both the inlet and outlet ports and therefore require specialized design features.
It is important to specify and test the operating characteristics of the pressure regulator.
Pressure regulators are usually equipped with a device to control the flow, such as a flow control device or a fixed orifice. The flow rate can be measured using a flow meter or flow meter.
show.
It is essential to ensure that the pressure regulator continues to meet the requirements of this document through regular inspection and maintenance.
This document focuses in particular on.
---Material suitability;
---Safety (mechanical strength, leakage, safe discharge in case of overpressure and flame retardancy);
---Gas specificity;
---Cleanliness;
---Type test;
---Identification;
---Information provided by the manufacturer.
Appendix A contains the rationale for some of the requirements of this document. Clauses and subclauses marked with an asterisk (*) after the number have corresponding
The rationale includes the reasons for the requirements and recommendations of this document. Understanding the reasons for these requirements will not only help in the correct application of this document, but also
and will expedite subsequent revisions.
An asterisk (*) at the beginning of a title, paragraph, or table indicates that there are related guidelines or rationales in Appendix A.
Medical gas pressure regulators Part 1.Pressure
Regulators and pressure regulators with flow meters
1 Scope
This document specifies the requirements for medicinal gases and their mixtures intended for use in the treatment, management, diagnostic assessment and care of patients or to actuate surgical instruments.
Design, construction, type testing and marking requirements for pressure regulators (see 3.17) used for gas management.
Examples. Gases include oxygen, medical air, and oxygen/nitrous oxide (laughing gas) mixtures.
Pressure regulators to which this document applies.
a) intended to be connected to the cylinder by an operator;
b) intended to be connected to the cylinder by the operator and with an integrated flow meter device;
c) It is an integral part of medical equipment (e.g. anesthesia workstation, ventilator, resuscitator).
The pressure regulator can provide a pressure outlet or a flow outlet and can be adjusted or preset.
The pressure regulator is intended for installation on refillable gas cylinders with a working pressure of up to 30000 kPa (300 bar) and can provide control
and a device for measuring the flow rate of delivered medical gases.
2 Normative references
The contents of the following documents constitute the essential clauses of this document through normative references in this document.
For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to
This document.
GB/T 1226 General pressure gauge
GB 9706.1 Medical electrical equipment Part 1.General requirements for basic safety and essential performance (GB 9706.1-2020, IEC
60601-1.2012,MOD)
GB/T 15382-2021 General technical requirements for gas cylinder valves (ISO 10297.2014, NEQ)
GB/T 15383 Gas cylinder valve outlet connection types and dimensions (GB/T 15383-2011, ISO 5145.2004, NEQ)
GB/T 42062 Medical Device Risk Management Application to Medical Devices (GB/T 42062-2022, ISO 14971.2019,
IDT)
GB/T 45898.1 Terminals for medical gas piping systems Part 1.Terminals for compressed medical gases and vacuum
(GB/T 45898.1-2025,ISO 9170-1.2017, MOD)
GB/T 45899 Compatibility of anesthetic and respiratory equipment with oxygen (GB/T 45899-2025, ISO 15001.2010, MOD)
GB 50751 Technical Specification for Medical Gas Engineering
ISO 407 Small medical gas cylinders-Pin-index yoke-type valve connections
valve connections)
Tubing and connectors
The following terms and definitions apply to this document.
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GB/T 45897.1-2025: Pressure regulators for use with medical gases - Part 1: Pressure regulators and pressure regulators with flow-metering devices
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