GB/T 44059.1-2024Medical gas pipeline systems - Part 1: Pipeline systems for 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 44059 "Medical Gas Pipeline Systems". GB/T 44059 has been published in the following parts.

--- Part 1: Piping systems for compressed medical gases and vacuum.

This document is modified to adopt ISO 7396-1:2016 "Medical gas pipeline systems Part 1: Pipelines for compressed medical gases and vacuum system".

The technical differences between this document and ISO 7396-1:2016 and their reasons are as follows.

--- The oxygen concentration requirement is changed to "the oxygen concentration shall be greater than or equal to 99.5%" (see Chapter 1) to adapt to my country's technology condition;

--- The definitions of oxygen and 93% oxygen (oxygen-enriched air) (see 3.45 and 3.46) have been changed to clarify their meanings and adapt to my country's technical conditions;

--- Added the definition of "design pressure" (see 3.69) to clarify its meaning;

--- Replace IEC 60601-1-8 (see 6.1) with the normative reference YY9706.108 to adapt to my country's technical conditions;

--- Replace IEC 60601-1-2 (see 4.1) with the normative reference YY9706.102 to adapt to my country's technical conditions;

--- Replace ISO 10524-2:2005 (see 4.3.5, 9.4, 9.5) with the normative reference YY/T 1439.2 to adapt to my country's technology condition;

---The material is changed to "seamless copper tube or seamless stainless steel tube" (see 4.3.6) to adapt to my country's technical conditions;

--- Replace EN13348 (see 4.3.6, 11.1.2) with the normative reference YS/T 650 to adapt to my country's technical conditions;

--- Replace ISO 14971 (see 5.2.2.3, 5.2.5, 8.1.2, 11.1.8) with the normative reference GB/T 42062 to adapt to my country Technical conditions;

--- Added normative reference document GB/T 12241 (see 5.2.6.7) to adapt to my country's technical conditions;

--- Replace ISO 21969:2009 (see 5.3.4) with the normative reference YY/T 1440 to adapt to my country's technical conditions;

--- The requirement for the medical air supply system for pressurizing the hyperbaric oxygen chamber is changed to "should be independent of the medical air supply system centrally supplied by the medical institution" Gas system" (see 5.5.1.4) to adapt to my country's technical conditions and improve operability;

--- The particle size (d) and the maximum allowable content of particulate matter per cubic meter (see 5.5.2.2) have been changed to adapt to my country's technical requirements.

Improve operability;

--- Added normative references GB/T 150 (all parts) (see 5.5.2.7, 5.6.6.4, 5.6.7), GB 50751 (see 5.9, 5.10, 10.1.2, 10.2) to adapt to my country's technical conditions;

--- Change "100%" in the medical air requirement to "105%" [see 5.5.3.1a)] to correspond to 23.63% (volume fraction) Numeric value;

--- The requirement for 93% oxygen (oxygen-enriched air) produced by the oxygen concentrator system is changed to "At the system design flow rate, the oxygen concentrator system the 93% oxygen (oxygen-enriched air) produced by the system should meet the requirements of WS1-XG-008-2012 (see 5.6.5.1) to adapt to my country's Technical conditions;

--- The filtration accuracy of each bacterial filter has been changed to adapt to my country's technical conditions and improve operability (see 5.7.11);

--- Replace ISO 3746 (see 6.3.2.1) with the normative reference GB/T 3768 to adapt to my country's technical conditions;

--- The compressed medical gas pipeline distribution system should be able to withstand the maximum pressure.

1.15 times of the design pressure of the pipeline", and the duration is changed to "10 min" (see 7.1, 12.6.1.3, 12.6.1.5, 12.6.1.6, 12.6.1.7, C.3.1.1.2, C.3.1.3.2, C.3.1.5.2.1, C.3.1.6.2.1), in order to adapt to my country's technical conditions and improve operability Sex;

--- Deleted the requirements for DISS and SIS connectors (see 8.3.8, 9.2, 12.6.4, 12.6.5) to adapt to my country's technical conditions;

--- Added normative reference document DIN13260-2 (see 9.1) to adapt to my country's technical conditions;

--- Replace ISO 9170-1:2008 (see 9.1, 9.2) with the normative reference YY/T 0801.1 to adapt to my country's technical conditions;

--- Replace ISO 11197:2004 (see 9.3) with the normative reference GB/T 43952 to adapt to my country's technical conditions;

---Replace ISO 17672 (see 11.3.1) with the normative reference GB/T 10046 or GB/T 6418 to adapt to my country's technology condition;

---Replace EN1254-1 or EN1254-4 (see 11.3.3) with the normative reference GB/T 11618.1 to adapt to my country's technology condition;

--- Deleted "All tests should be carried out by the manufacturer under the supervision of authorized personnel of a medical institution" (see 12.1) to improve operability.

The following editorial changes were made to this document.

--- Incorporated the amendments to ISO 7396-1:2016/Amd1.2017, the outer page blanks of the clauses involved are marked with vertical Double lines are marked;

--- Added some notes (see Chapter 2, 3.11, 5.8.2);

--- Changed some notes (see 4.3.6, 5.8.1, 11.3.2, 12.6.14);

--- Deleted some notes (see Introduction, Chapter 1, Chapter 2, 3.19, 3.20, 3.53, 3.56, 4.2, 4.3.2, 4.3.4, 4.3.5, 4.3.6, 4.4.1, 5.2.6.3, 5.4, 5.5.2.1, 5.5.2.2, 5.5.2.3, 5.5.3.8, 5.6.1, 5.6.5.1, 5.6.6.1, 5.6.8.5, 5.6.9.2, 5.7.10, 6.6, 7.2.1, 7.2.5, 7.2.6, 10.1.2, 10.2, 11.1.4, 11.1.5, 11.1.7, 11.2, 12.1, 12.6.1, 12.6.7, 12.6.11, 12.6.13, 12.6.14, 12.6.16, 13.3.1, B.1, B.2, B.3.1, G.2.1, G.5.9.6, Appendix J);

--- Added the informative reference document GB 50751 (see 5.8.1, 5.8.2);

--- Replace ISO 4126-1 with the informative reference GB/T 12241 (see 7.2.5, 7.2.6);

--- Replace ISO 10524-2 with the informative reference YY/T 1439.2 (see 7.4.1);

---Deleted the content in G.5.9.19 (see G.5.9.19).

Introduction

GB/T 44059 "Medical Gas Pipeline Systems" is intended to consist of the following parts.

--- Part 1: Piping systems for compressed medical gases and vacuum. The purpose is to ensure that the piping systems for compressed medical gases and vacuum Specifications for design, installation, testing, acceptance and operation.

--- Part 2: Anesthetic gas purification system. The purpose is to ensure the installation, testing, acceptance and operation of the anesthetic gas purification system.

Compatibility between operating specifications and system components.

Many healthcare facilities use piping systems to deliver medical gases and provide vacuum to patient care areas, or to power ventilators and surgical instruments.

And other equipment to provide driving force.

This document specifies the requirements for pipeline systems for pharmaceutical gases, medical device gases, surgical instrument drive gases and vacuum gases.

For use by persons involved in the design, construction, inspection and operation of medical facilities that treat human beings.

Personnel working on connected equipment also need to be aware of the contents of this document.

This document is intended to ensure that medical gas pipelines contain only the specific gas (or vacuum) to be supplied. Therefore, gas-specific components are used for terminal and other connections for operator use. In addition, each system is tested and certified to contain only the dedicated gas (or vacuum).

The objectives of this document are to ensure the following.

a) Different piping systems are not interchangeable through design, installation and testing;

b) Continuously supply gas and vacuum of specified quality, pressure and flow by providing an appropriate gas source;

c) use of appropriate materials;

d) cleanliness of components;

e) Correct installation;

f) provide monitoring and alarm systems;

g) Proper marking of piping systems;

h) testing and acceptance;

i) the quality of gas transmitted by the pipeline system;

j) Proper operation management;

k) Safety features of the gas source to ensure that the gas quality meets the specifications.

Annex G provides guidance on the allocation of responsibilities for the production and quality control of gases and vacuums.

Appendices G and K provide some guidance on how gas quality can be managed to maintain patient safety at the highest level.

Appendix H contains the rationale for some of the requirements of this document. It provides the basis for the requirements and recommendations that have been included in this document.

Other opinions. The chapters and clauses marked with an * after the number have corresponding explanations in Appendix H.

This document focuses on the safety and effectiveness of medical gas pipeline systems and specifies the design, installation, function, Performance, testing, acceptance and documentation requirements. For new, renovated or expanded centralized medical gas supply projects in medical and health institutions for relevant requirements, see GB 50751.

Medical gas pipeline systems Part 1: Piping systems for compressed medical gases and vacuum

1 Scope

This document specifies the design, installation, function, performance, testing, acceptance and documentation of the following gas pipeline systems used in healthcare facilities.

Requirements.

---oxygen;

--- Nitrous oxide;

---Medical air;

---carbon dioxide;

---Oxygen/nitrous oxide mixtures;

---Helium/oxygen mixture;

---*93% oxygen (oxygen-enriched air);

--- Gases and gas mixtures classified as medical devices, gases delivered to medical devices or for medical purposes, or gases used for medical purposes Gases and gas mixtures other than those mentioned above;

--- Air for driving surgical instruments;

---Nitrogen for driving surgical instruments;

---vacuum.

NOTE 1 Anesthetic gas purification systems are covered in ISO 7396-2.

This document includes requirements for supply systems, piping distribution systems, control systems, monitoring and alarm systems, and different gas/vacuum systems.

Non-interchangeability of parts.

This document specifies the safety requirements for piping systems used in healthcare facilities.

This document applies to all facilities that provide health care services, regardless of type, size, location, or scope of services, including but not limited to.

a) Acute care medical facilities;

b) Internal patient continuing care healthcare facilities;

c) long-term care facilities;

d) community-based providers;

e) Outpatient and external patient care clinics (e.g. day surgery, endoscopy clinics and physicians' offices).

NOTE 2 This document may also be used as a reference for medical gas and vacuum piping systems installed outside medical facilities.

This document applies to the following different types of oxygen supply systems.

---When all gas sources in the supply system provide oxygen, the oxygen content will be greater than or equal to 99.5%;

---When all gas sources in the supply system provide 93% oxygen (oxygen-enriched air), the oxygen content can be between 90% and 96% Variety.

NOTE 3 A mixture of 93% oxygen (oxygen-enriched air) and oxygen can be delivered through the medical gas supply system. In this case, the gas concentration can be between 90% and Varies between or equal to 99.5%.

This document also applies to.

--- Expansion of existing pipeline distribution systems;

---Reconstruction of existing pipeline distribution systems;

---Reconstruction or replacement of supply systems or supply sources.