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Anaesthetic and respiratory equipment - Low-pressure hose assemblies for use with medical gases
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GB/T 46042-2025
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Basic data | Standard ID | GB/T 46042-2025 (GB/T46042-2025) | | Description (Translated English) | Anaesthetic and respiratory equipment - Low-pressure hose assemblies for use with medical gases | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | C46 | | Classification of International Standard | 11.040.10 | | Word Count Estimation | 26,267 | | 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 46042-2025: Anaesthetic and respiratory equipment - Low-pressure hose assemblies for use with medical gases
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ICS 11.040.10
CCSC46
National Standard of the People's Republic of China
Medical gas low-pressure hose assemblies for anesthesia and respiratory equipment
(ISO 5359.2014, 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 General Requirements 4
4.1 Risk Management 4
4.2 Availability 4
4.3 Clinical Evaluation
4.4 Security 4
4.5 Materials 5
4.6 Design Requirements 5
4.7 Structural requirements 7
5 Test methods 7
5.1 Overview 7
5.2 Test method for pressure drop 8
5.3 Leakage test method 8
5.4 Test methods for gas specificity 8
5.5 Test method for mechanical strength 8
5.6 Test method for pressure deformation 8
5.7 Anti-blocking test method 8
5.8 Test method for durability of markings and color identification 9
6 Marking, color coding and packaging10
6.1 Mark 10
6.2 Color identification 10
6.3 Packaging 10
7 Information provided by the manufacturer11
Appendix A (Informative) Basic Principles 13
Appendix B (Informative) Environmental Aspects 14
Appendix C (Informative) Differences in the color identification and naming of medical gases between regions or countries 15
Reference 17
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 modified to adopt ISO 5359.2014 "Medical gas low-pressure hose assemblies for anesthetic and respiratory equipment".
The technical differences between this document and ISO 5359.2014 and their reasons are as follows.
--- ISO 14971 (see 4.1, 4.4) is replaced by the normative reference GB/T 42062 to adapt to my country's technical conditions;
--- ISO 1307 (see 4.6.1.3) is replaced by the normative reference GB/T 9575 to adapt to my country's technical conditions;
--- ISO 8033 (see 4.6.5) is replaced by the normative reference GB/T 14905 to adapt to my country's technical conditions;
--- ISO 9170-1 (see 4.6.8) is replaced by the normative reference GB/T 45898.1 to adapt to my country's technical conditions;
--- ISO 15001 (see 4.7.1) is replaced by the normative reference GB/T 45899 to adapt to my country's technical conditions;
--- ISO 1402 (see 5.6) is replaced by the normative reference GB/T 5563 to adapt to my country's technical conditions;
--- Deleted the normative reference ISO 14155 (see 4.3 of ISO 5359.2014) to adapt to my country's technical conditions;
--- Deleted the requirements for DISS and SIS connectors (see 1.3, 3.4, 4.6.8 of ISO 5359.2014) to adapt to my country's technology
condition;
--- Changed the requirements for clinical evaluation (see 4.3) to adapt to my country's technical conditions;
--- Changed the test method for durability of marking and color identification (see 5.8) to adapt to my country's technical conditions;
--- Deleted the color identification requirements of other regional or national standards (see 6.2.1 of ISO 5359.2014) to adapt to my country's technology
condition.
The following editorial changes have been made to this document.
--- Incorporated the amendments to ISO 5359.2014/Amd1.2017, the outer margins of the clauses involved are indicated by vertical
Double lines (‖) are marked;
--- Replaced ISO 9170-1 with the informative reference GB/T 45898.1 (see Chapter 1);
--- Replaced ISO 18082 with the informative reference GB/T 45895 (see Chapter 1);
--- Replaced IEC 60601-1-6 with the informative reference YY/T 9706.106-2021, and replaced IEC 62366 with YY/T 1474
(see 4.2);
--- Replaced ISO 15001 with the informative reference GB/T 45899 (see 4.5.1);
--- Replaced ISO 1402 with the informative reference GB/T 5563 (see 5.5.1);
--- Deleted the unreferenced terms "accompanying documents", "basic safety", "maximum working pressure", "medical gas pipeline system", "non-interchangeable
threaded joints” and “93% oxygen” (see 3.2, 3.3, 3.13, 3.15, 3.16 and 3.19 of ISO 5359.2014);
--- Deleted the content of the note (see 4.3 of ISO 5359.2014).
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., GE Medical Systems
(China) Co., Ltd.
The main drafters of this document are. Wang Wei, Xia Junliang, Wang Wei, Zhang Chunyuan, Wang Yongyi, Xiong Zhibin, and Yu Hongyi.
introduction
This document was developed because there is a need for a safe method of connecting medical equipment to a fixed medical gas piping system or
Other medical gas supply systems to meet the requirement that hose assemblies conveying different gases or the same gas at different pressures cannot be interchanged.
Once the fixed medical gas pipeline is installed, it cannot be moved at will and must be used in accordance with the prescribed procedures to prevent cross mixing of medical gases.
However, in a relatively short period of use, hose assemblies are frequently connected to medical equipment and fixed gas pipelines.
Connecting and disconnecting are subject to wear, tear, misuse and abuse.
While recognizing that no system is completely safe, this document contains information to prevent foreseeable hazards arising from the use of hose assemblies.
The operator must always be alert to the possibility of damage caused by external factors. Therefore, regular inspections and maintenance are required to ensure that
Ensure that the hose assembly continues to meet the requirements of this document.
This document focuses in particular on.
---Material suitability;
---Gas specificity;
---Prevent cross connection;
---clean;
---test;
---Identification;
---Information provided by the manufacturer.
ISO 17256 covers the requirements for respiratory therapy circuits and refers to ISO 80369-2 for small-bore breathing systems and drive gases.
Requirements for connectors.
In order to avoid the danger of cross-mixing between components of different gases and to facilitate the connection between components of the same gas, this
This document only allows the use of NIST (non-interchangeable thread system) connectors specified in GB/T 45895.
Medical gas low-pressure hose assemblies for anesthesia and respiratory equipment
1 Scope
This document specifies the use of oxygen, nitrous oxide (laughing gas), medical air, helium, carbon dioxide, xenon, and specific mixtures of these gases.
Requirements for low-pressure hose assemblies for medical gases such as 93% oxygen, air for driving surgical instruments, nitrogen for driving surgical instruments, and vacuum.
This document applies to hose assemblies with a working pressure not exceeding 1400kPa and vacuum system hose assemblies with an absolute pressure not exceeding 60kPa.
This document does not specify the size and configuration of gas-specific inlet and outlet fittings for hose assemblies.
Note 1.The dimensions and configurations of non-interchangeable threaded (NIST) fittings are specified in GB/T 45895.
Note 2.Terminals designed for quick connectors are specified in GB/T 45898.1.
This document does not specify requirements for coaxial hoses used for the supply and exhaust of air used to drive surgical instruments.
This document does not specify the intended use of the hose assembly.
Note 3.For environmental factors, see Appendix B.
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 5563 Rubber and plastic hoses and hose assemblies - Test methods for hydrostatic pressure (GB/T 5563-2025, ISO 1402.
2021, IDT)
GB/T 9575 Rubber and plastic hoses Specifications and maximum and minimum inner diameters and cut length tolerances (GB/T 9575-2013,
ISO 1307.2006, IDT)
GB/T 14905 Rubber and plastic hoses - Determination of interlayer adhesion strength (GB/T 14905-2020, ISO 8033.2016,
IDT)
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)
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1
accessory
Additional parts for use with equipment to.
---Achieve the intended purpose;
--- Make the equipment suitable for some specific purposes;
---Easy to use the equipment;
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GB/T 46042-2025: Anaesthetic and respiratory equipment - Low-pressure hose assemblies for use with medical gases
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