GB/T 45811-2025 English PDF

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GB/T 45811-2025: Anaesthetic vaporizers - Agent-specific filling systems
Status: Valid

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GB/T 45811-2025	459	Add to Cart	3 days	Anaesthetic vaporizers - Agent-specific filling systems	Valid

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Basic data

Standard ID: GB/T 45811-2025 (GB/T45811-2025)
Description (Translated English): Anaesthetic vaporizers - Agent-specific filling systems
Sector / Industry: National Standard (Recommended)
Classification of Chinese Standard: C46
Classification of International Standard: 11.040.10
Word Count Estimation: 22,255
Date of Issue: 2025-05-30
Date of Implementation: 2026-06-01
Issuing agency(ies): State Administration for Market Regulation, China National Standardization Administration

GB/T 45811-2025: Anaesthetic vaporizers - Agent-specific filling systems

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
ICS 11.040.10 CCSC46 National Standard of the People's Republic of China Anesthetic agent filling system for anesthesia vaporizer (ISO 5360.2016,MOD) Released on 2025-05-30 2026-06-01 implementation State Administration for Market Regulation The National Standardization Administration issued

Table of contents

Preface III 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 bottles 2 5 Bottleneck Ring 3 6 Bottle adapter 6 7 Filling socket 10 8 Filling rate 12 9 Leakage 12 10 Overfilling protection 12 11 Color identification 12 12 Availability12 13 Clinical evaluation12 14 Information provided by the manufacturer13 14.1 Identification 13 14.2 Tags 13 14.3 User Manual 13 Appendix A (Informative) Recommendations on Materials 14 Appendix B (informative) Types of dedicated anesthetic filling systems 15 Appendix C (Normative) Test of total leakage of anesthetic during filling 16 Reference 17

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 modified to adopt ISO 5360.2016 "Specialized filling systems for anesthetic vaporizers". The technical differences between this document and ISO 5360.2016 and their reasons are as follows. --- ISO 1101 was replaced by the normative reference GB/T 1182 to adapt to my country's technical conditions (see Figure 1). The following editorial changes were made to this document. --- Added examples of Chinese color system (see Table 2); --- Change the term dedicated anesthetic filling system to injection (see 3.2). 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. Beijing Aeon Medical Systems Co., Ltd., Shanghai Institute of Medical Device Inspection, Shenzhen Mindray Biomedical Medical Electronics Co., Ltd. and Beijing Yishiheng Electronic Technology Co., Ltd. The main drafters of this document are. Du Guofeng, Luo Jiahao, Ma Xiaojian, Li Chunlei, Sun Xinxing, Wang Wei, Li Zheng, Deng Yongru and Yu Hongyi. Anesthetic agent filling system for anesthesia vaporizer

1 Scope

This document specifies the requirements, including dimensions, for filling systems for anesthetic agent-specific vaporizers used with anesthetic agent-specific vaporizers. This document applies to dedicated filling systems for anesthetic agents. Materials of construction are not specified in this document. Note 1.For material recommendations, see Appendix A. Due to the unique properties of desflurane, this document does not specify the dimensions of a dedicated filling system for this anesthetic agent. Note 2.It is encouraged to design a connection system between a dedicated anesthetic bottle connector and an anesthetic bottle with a neck ring.

2 Normative references

The contents of the following documents constitute 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 1182 Product Geometric Specification (GPS) Geometric Tolerances Shape, Orientation, Position and Runout Tolerances (GB/T 1182- 2018,ISO 1101.2017,MOD)

3 Terms and definitions

The following terms and definitions apply to this document. 3.1 Anesthetic agent-specific It has the specified structure and size and is specially designed for the specified liquid anesthetic. 3.2 Anesthetic agent filling system agent-specific filling system A functional system for identifying the connection between an anesthetic agent bottle and an anesthetic agent-specific (3.1) anesthetic vaporizer (3.3). Note 1 to entry. It consists of a threaded neck (3.7) with a neck ring (3.5), a bottle connector (3.6), an adapter plug (3.9) and a filling socket (3.8). Note 2.Appendix B lists different types of dedicated anesthetic filling systems. 3.3 Anesthesia vaporizer anaestheticvaporizer A device that causes liquid anesthetic to become gaseous. 3.4 Bottle adapterbottleadaptor An assembly for connecting a bottle of liquid anesthetic agent and an anesthetic vaporizer (3.3) dedicated to anesthetic agent (3.1). 3.5 Bottle Colar The anesthetic-only (3.1) component located at the bottleneck makes it anesthetic-only (3.1). ......

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