GB/T 45898.1-2025Terminal units for medical gas pipeline systems - Part 1: Terminal units for use with compressed medical gases and vacuum (English PDF)

Foreword

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 45898 "Terminals for medical gas pipeline systems". GB/T 45898 has been published in the following parts.

--- Part 1: Terminals for compressed medical gases and vacuum.

This document is modified to adopt ISO 9170-1:2017 "Medical gas pipeline system terminals Part 1: Terminals for compressed medical gases and vacuum Terminal".

This document has the following structural adjustments compared to ISO 9170-1:2017.

--- The description of the contents of Table 1 in 5.1.1 corresponds to the contents of 5.1 in ISO 9170-1:2017;

---A.2.4 and A.2.7 correspond to the contents of A.2.5 and A.2.4 in ISO 9170-1:2017;

---A.2.6 corresponds to the principle description of the terminal maintenance valve in 5.6 of ISO 9170-1:2017.

The technical differences between this document and ISO 9170-1:2017 and their reasons are as follows.

--- Replaced ISO 7396-1:2016 (see Chapter 1, 5.7.1, 9.2.1) with the normative reference GB/T 44059.1 to adapt to my country Technical conditions;

--- Added normative references GB/T 45897.1, GB/T 45897.3, YY/T 0801.2 (see Chapter 1) to adapt to my country's Technical conditions;

--- "93% oxygen" is changed to "93% oxygen (oxygen-enriched air)" (see Chapter 1, 8.2);

--- ISO 14971 (see 4.1) is replaced by the normative reference GB/T 42062 to adapt to my country's technical conditions;

--- Changed the time for bearing the test pressure in 5.1.1 (see 5.1.1) to be consistent with GB/T 44059.1;

--- Replaced ISO 5359:2014 (see 5.7.2) with the normative reference GB/T 46042 to adapt to my country's technical conditions;

--- Replaced ISO 15001:2010 (see 6.1) with the normative reference GB/T 45899 to adapt to my country's technical conditions;

--- Replaced ISO 6506-1 (see 7.2.1) with the normative reference GB/T 231.1 to adapt to my country's technical conditions;

--- ISO 32 (see 8.2.2) is replaced by the normative reference GB 50751 to adapt to my country's technical conditions;

--- Deleted the terms and requirements of DISS and SIS connectors to adapt to my country's technical conditions;

--- Deleted the unreferenced terms "low-pressure hose assembly" and "medical device gas" to adapt to my country's technical conditions;

--- Deleted the color identification requirements of other regional or national standards to adapt to my country's technical conditions.

The following editorial changes have been made to this document.

---Deleted some notes in the text;

--- Replaced ISO 15001 with the informative reference GB/T 45899 (see 4.3.1);

--- Replaced ISO 15001:2010 with the informative reference GB/T 45899-2025 (see 4.3.4);

--- Replaced ISO 7396-1:2016 with the informative reference GB/T 44059.1-2024 (see 5.11);

--- Changed the "Note" under Table 2 (see 5.11);

--- Changed the error in the reference table in 7.2, changing "Table 1" to "Table 2" (see 7.2.1, 7.2.2);

--- Replaced ISO 7396-1 with the informative reference GB/T 44059.1 (see A.2.5, A.2.6);

--- Added the titles A.2.1 to A.2.7 (see A.2);

--- Added the electrical installation conditions requirements for China in Table C.1 (see Appendix C).

Introduction

GB/T 45898 "Medical Gas Pipeline System Terminals" is intended to consist of the following two parts.

--- Part 1: Terminals for compressed medical gases and vacuum. The purpose is to specify the terminals for compressed medical gases and vacuum Requirements for its inserts and test methods are given.

--- Part 2: Terminals for use in anesthetic gas purification systems. The purpose is to specify the terminal intended for use in accordance with ISO 7396-2 Requirements, dimensions and test methods for terminals and their inserts in anesthetic gas purification systems.

The terminal is a connection point on the medical gas pipeline system, used by the operator to connect and disconnect the anesthesia machine, ventilator or other medical equipment.

For medical gas supply. Terminals are also used for vacuum piping systems. A wrong connection may be harmful to the patient or operator. Therefore, it is important that the terminal and its components be designed, manufactured, installed, and maintained in accordance with the requirements specified in this document.

Special attention should be paid to this document.

---Material suitability;

---Gas specificity;

---clean;

---test;

---Identification;

---Information provided.

This document contains information on installing and testing the terminal before use. Testing the terminal before use is crucial to patient safety.

The terminal cannot be put into use until it has completed comprehensive testing in accordance with GB/T 44059.1.

Medical gas pipeline system terminals Part 1: Terminals for compressed medical gases and vacuum

1 Scope

This document specifies the gas-specific components, mechanical resistance, flow, leakage and pressure drop of the terminal and prevents the interaction between different gases and facilities.

Terminals for supplying and processing nitrogen and air for driving surgical instruments, and inserts for connecting dedicated gas connection ports Require.

This document applies to pressure regulators intended for use in medical gas pipeline systems that comply with GB/T 44059.1 and GB/T 45897.1.

The pressure outlet of the gas cylinder valve and the pressure regulator (VIPR) of the integrated gas cylinder valve in accordance with GB/T 45897.3.with oxygen, Nitrous oxide, medical air, carbon dioxide, oxygen/nitrous oxide mixture, helium/oxygen mixture, 93% oxygen (oxygen-enriched air), classified as medical devices Gases and mixed gases supplied to medical devices, gases delivered to medical devices or used for medical purposes, or medicinal gases and mixed gases not specified above Terminals for patient use or medical purposes and terminals for use with air for driving surgical instruments and nitrogen for driving surgical instruments, and Terminals for use with vacuum piping systems.

This document does not specify the dimensions of the inserts or dedicated gas connections.

This document does not specify the requirements for terminals used in anesthetic gas scavenging systems (AGSS) to which YY/T 0801.2 applies.

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 231.1 Metallic materials Brinell hardness test Part 1: Test method (GB/T 231.1-2018, ISO 6506-1.

2014, MOD)

GB/T 42062 Medical Device Risk Management Application to Medical Devices (GB/T 42062-2022, ISO 14971:2019, IDT) GB/T 44059.1 Medical gas piping systems Part 1: Piping systems for compressed medical gases and vacuum (GB/T 44059.1-2024, ISO 7396-1:2016, MOD) GB/T 45897.1 Medical gas pressure regulators Part 1: Pressure regulators and pressure regulators with flow meters (GB/T 45897.1-2025,ISO 10524-1:2018,MOD) GB/T 45897.3 Medical gas pressure regulators Part 3: Pressure regulators with integrated cylinder valves (VIPRs) (GB/T 45897.3-2025,ISO 10524-3:2019, MOD) GB/T 45899 Compatibility of anesthetic and respiratory equipment with oxygen (GB/T 45899-2025, ISO 15001:2010, MOD) GB/T 46042 Low-pressure hose assemblies for medical gases for anesthesia and respiratory equipment (GB/T 46042-2025, ISO 5359:2014, MOD) GB 50751 Technical Specification for Medical Gas Engineering YY/T 0801.2 Terminals for medical gas piping systems Part 2: Terminals for anesthetic gas purification systems (YY/T 0801.2-2010,ISO 9170-2:2008,IDT) ISO 11114-3 Gas cylinders — Compatibility of cylinder and valve materials with gas contents — Part 3: Compatibility of non-metallic materials with oxygen atmospheres