GB/T 45663-2025 English PDF

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GB/T 45663-2025: Anaesthetic and respiratory equipment - User-applied labels for syringes containing drugs used during anaesthesia - Colours, design and performance
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
GB/T 45663-2025	299	Add to Cart	3 days	Anaesthetic and respiratory equipment - User-applied labels for syringes containing drugs used during anaesthesia - Colours, design and performance	Valid

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Basic data

Standard ID: GB/T 45663-2025 (GB/T45663-2025)
Description (Translated English): Anaesthetic and respiratory equipment - User-applied labels for syringes containing drugs used during anaesthesia - Colours, design and performance
Sector / Industry: National Standard (Recommended)
Classification of Chinese Standard: C46
Classification of International Standard: 11.040.10
Word Count Estimation: 14,176
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 45663-2025: Anaesthetic and respiratory equipment - User-applied labels for syringes containing drugs used during anaesthesia - Colours, design and performance

---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 Anesthesia and respiratory equipment during anesthesia For use on syringes containing medication Label colors, patterns and features (ISO 26825.2020,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 General requirements 1 4.1 Paste Requirements 1 4.2 Adhesive tape label 1 4.3 Material 1 4.4 Packaging 2 5 Color, size and pattern requirements 2 5.1 General requirements 2 5.2 Background color and pattern 2 5.3 Label size 2 5.4 Color, character size and position of drug names 2 References 7

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 modifies ISO 26825.2020 “Anesthetic and respiratory equipment – Labels for use on syringes containing medication during anaesthesia” Color, Pattern and Character. This document has the following structural adjustments compared to ISO 26825.2020. --- Adjust Chapter 6 to the note of 5.4.2. The technical differences between this document and ISO 26825.2020 and their reasons are as follows. --- Deleted the regional differences in alphabetical drug names and font requirements (see Chapter 6 of ISO 26825.2020) to adapt to my country technical conditions. The following editorial changes were made to this document. --- Changed the content of the note (see Chapter 1); --- Deleted Note 1 and Note 2 of 5.4.2 in ISO 26825.2020. 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, University of Shanghai for Science and Technology, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. company. The main drafters of this document are. Zhang Zhijing, Zhang Peiming, Ma Xiaojian, Wang Wei, Li Xinsheng, Yu Hongyi and Yu Tao. Anesthesia and respiratory equipment during anesthesia For use on syringes containing medication Label colors, patterns and features Warning. The use of colors is only to help identify drug groups and does not exempt the user from reading the label and correctly identifying the drug before use. responsibility.

1 Scope

This document specifies the color, size, pattern and general characteristics of the label and specifies the printing characteristics of the text of the drug name. This document applies to labels that are affixed to syringes to identify the drug in the syringe before it is administered during anaesthesia. Note. Label color is only to help identify different types of drugs, but it does not relieve the user of the responsibility to read the label content and confirm the drug before administering it.

2 Normative references

This document has no normative references.

3 Terms and definitions

There are no terms or definitions that require definition in this document.

4 General requirements

4.1 Paste requirements The labels shall be self-adhesive and shall withstand the following test procedures. a) Stick the label on a 10mL syringe and place it at (23±2)℃ for at least 12h; Note. Polyethylene has poor adhesion and can represent the most unfavorable condition of the test, so a test syringe made of polyethylene is selected. b) Immerse the syringe and label in 50% isopropanol for 5 minutes; c) After soaking, take the syringe out of the liquid, keep the syringe vertical, and air dry for 5 minutes; d) When the label is touched by hand, it should not shift, curl or have edges lifted. 4.2 Tape Label If the label is in the form of tape, there should be perforations or obvious marks at the separation between the labels. If the label has a backing, the label should be separated from the backing and the corresponding Attached labels should be able to be easily separated. Compliance is checked by visual inspection and functional test. 4.3 Materials The material of the label should be suitable for users to write additional information on the label (such as drug concentration) and should not be blurred after writing with a ballpoint pen. Or form stains. Check compliance with requirements through functional tests. ......

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