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GB/T 45663-2025Anaesthetic and respiratory equipment - User-applied labels for syringes containing drugs used during anaesthesia - Colours, design and performance (English PDF)

麻醉和呼吸设备麻醉期间用于贴示在含药的注射器上的标签颜色、图案和特性

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Issued by

State Administration for Market Regulation, China National Standardization Administration

Level / Type

National · Recommended

Issue date

May 30, 2025

Implementation date

June 1, 2026

Scope

GB/T 45663-2025 is the English-translated version of 麻醉和呼吸设备麻醉期间用于贴示在含药的注射器上的标签颜色、图案和特性.

GB/T 45663-2025 — 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.

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Document preview — GB/T 45663-2025

National Standard of the People's Republic of China

ICS: 11.040.10
Classification: C 46

Issued by: State Administration for Market Regulation, China National Standardization Administration

Preface
1 Scope
2 Normative references
3 Terms and Definitions
4 General requirements
4.1 Paste Requirements
4.2 Adhesive tape label
4.3 Material
4.4 Packaging
5 Color, size and pattern requirements
5.1 General requirements
5.2 Background color and pattern
5.3 Label size
5.4 Color, character size and position of drug names
References

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.

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)°C 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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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 10 pages — is available in the English PDF.

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