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YY/T 0573.2-2025Sterile hypodermic syringes for single use - Part 2: Syringes for use with power-driven syringe pumps (English PDF)

一次性使用无菌注射器第2部分：动力驱动注射泵用注射器

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Issued by

National Medical Products Administration

Level / Type

National · Recommended

Issue date

September 15, 2025

Implementation date

October 1, 2026

Scope

YY/T 0573.2-2025 is the English-translated version of 一次性使用无菌注射器第2部分：动力驱动注射泵用注射器.

YY/T 0573.2-2025 — This document specifies the requirements for power-driven syringes with nominal capacities of 1 mL and above, made of polymer materials. The requirement is for a power-driven syringe pump that is used in conjunction with a manufacturer-approved syringe pump.

This document does not apply to syringes with self-destruct mechanisms, insulin syringes, glass syringes, or syringes pre-filled with medication by the manufacturer.

This includes syringes used with the medication. This document does not address the compatibility of pump-operated syringes with the injected medication.

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Document preview — YY/T 0573.2-2025

National Standard of the People's Republic of China

ICS: 11.040.25
Classification: C 31
Replacing: YY/T 0573.2-2018

Issued by: National Medical Products Administration

Foreword
Introduction
0.1 General Provisions
0.2 Design Specifications
0.3 Syringe Recognition
0.4 Selection of Infusion Rate and Nominal Syringe Capacity
1 Scope
2 Normative references
3 Terms and Definitions
4 Naming
5 PH
6 Extractable metal content

Foreword

This document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part 1: Structure and Drafting Rules of Standardization Documents".

Drafting.

This document is Part 2 of YY/T 0573 "Disposable Sterile Syringes". YY/T 0573 has already published the following parts.

---Part 2: Syringes for Powered Injection Pumps;

---Part 3: Self-Destructing Fixed-Dose Vaccine Injector;

---Part 4: Preventing the reuse of syringes.

This document replaces YY/T 0573.2-2018 "Disposable Sterile Syringes - Part 2: Power-Driven Injection Pumps" Compared with YY/T 0573.2-2018, the main technical changes in the "Equipment" standard, apart from structural adjustments and editorial modifications, are as follows.

---Add syringes with a nominal capacity of 1mL to 5mL to the scope of this document (see Chapter 1, Chapter 1 of the 2018 edition);

---The overall flow requirement in Chapter 14 has been removed because it is primarily affected by the inner diameter (ID) of the outer casing, which was addressed in Chapter 11;

---The test speed of the pump is adjusted for the nominal capacity of each syringe to better reflect the speed range set in a typical clinical setting.

This document is modified to adopt ISO 7886-2:2020 "Disposable sterile syringes – Part 2: Powered syringe pumps for use with sterile syringes".

The main technical differences between ISO 7886-2:2020 and ISO 7886-2:2020, and the reasons for these differences, are as follows.

---ISO 3696 (see A.3.2, B.2.2, C.2.2) has been replaced with the normatively referenced GB/T 6682 to adapt to my country's technical requirements.

Improve operability;

---ISO 7886-1:2017 has been replaced by the normatively referenced GB 15810-2019 (see Chapters 3, 4, 5, and 6).

Chapters 6, 7, 8, 9, 10, 11.1, 11.2, 12.2, 13.1, 13.2, 18, 19.1, 19.2, 19.3 19.4), to adapt to my country's technological conditions and increase operability;

---A section on "Test Methods for Dimension A" has been added to Chapter 10 to better suit my country's technological conditions and increase operability;

---The requirement for "easily oxidizable substances" has been added (see Chapter 14) to adapt to my country's technical conditions;

---The requirement for "ethylene oxide residue" has been added (see Chapter 15) to adapt to my country's technical conditions;

---The requirement of "sterility" has been added (see Chapter 16) to adapt to my country's technical conditions;

---The requirement for "bacterial endotoxins" has been added (see Chapter 17) to adapt to my country's technical conditions;

---The requirements for "syringe drive" (see A.3.1) have been amended to suit my country's technical conditions;

---The requirements for the "test apparatus" have been changed (see B.2.1) to suit my country's technical conditions.

Please note that some content in this document may involve patents. The issuing organization of this document assumes no responsibility for identifying patents.

This document was proposed by the National Medical Products Administration.

This document is under the jurisdiction of the National Technical Committee on Standardization of Medical Syringes (Needles) (SAC/TC95).

Introduction

YY/T 0573 "Disposable Sterile Syringes" consists of three parts.

---Part 2: Syringes for Powered Injection Pumps. This section specifies the particular requirements for syringes used in powered injection pumps.

---Part 3: Self-destructing fixed-dose vaccine syringes. Designed for self-destructing fixed-dose syringes that are no longer intended for use after a predetermined dose has been administered.

Regulations were established for the quantity of vaccine syringes;

---Part 4: Prevention of Syringe Reuse. This aims to cover situations where syringes are not reused during, after, or after the intended dose has been administered.

The syringe used in the procedure.

0.1 General Provisions

Early in the preparation of this document, it was recognized that this could only be achieved by combining the power-driven injection pump and syringe into a complete system.

Absolutely standard performance. The dependence of one component of a system on the performance of another is a key factor. When considering design changes, for the manufacturer of one component needs to maintain contact with the manufacturer of the other component to ensure the system operates satisfactorily. This is especially true for syringes.

Manufacturers should provide information regarding the acceptable tolerances, expected variations, and performance characteristics of the syringe dimensional deviations specified in this document, such as the moving core.

The force.

The test speed selected through flow accuracy testing revealed that lower speeds resulted in worse conditions, leading to larger variations; regardless, by Due to limitations in the weight testing method (such as the difficulty in balancing and measuring trace amounts of liquid using a static balance), a weight lower than [a certain value] is selected.

A rate of 1 mL/h is considered inappropriate.

It should be recognized that start-up time and initial position may affect pump power; if necessary, these factors should be considered for elimination.

The characteristics of the syringe driver and measuring device can affect the error of the test method; therefore, it is recommended to include appropriate equipment accuracy and precision.

Density levels were determined, and methodological validation was performed.

0.2 Design Specifications

Originally designed and used in manually operated syringes placed in syringe pumps, modern syringes now take a larger size than manual ones.

Using more stringent requirements is advisable.

It is understood that all syringe manufacturers worldwide invest heavily in molding and manufacturing equipment, such as changing the diameter of the trigger or the inner diameter of the outer casing.

The process of transformation has largely exceeded the capabilities of the syringe industry.

Typically, the fixed height of a syringe is not considered a particularly critical dimension. Its acceptable level is relatively low.

The dimensional properties are not only a function of the total length of the piston rod and outer sleeve, but also a function of the piston assembly and the thickness of the outer sleeve's rolled edge. The piston assembly thickness is...

Due to their relatively simple manufacturing process, the differences are significant. Because all these components are made using multi-cavity molds from numerous molds around the world...

The previously insignificant dimensions, accumulated through limit tolerances from cavity to cavity, from mold to mold, and from position to position, make these...

The parts cannot be tightened immediately.

0.3 Syringe Recognition

Importantly, when the syringe is mounted on the syringe pump, proper programming, with respect to the specific syringe being installed, ensures optimal pump performance.

satisfy.

Given the consequences of the pump failing to correctly identify the syringe, the need for an automated system was recognized. Efforts have been made to reduce syringe identification errors.

The methods currently in use, such as mechanical sensing of the syringe's outer diameter, are considered impractical in the long run. This is because different manufacturers produce...

The range of syringe diameters overlaps. It is also recognized that standardizing the syringe sheath diameter across the entire industry is not a realistic approach.

Options.

The pump is programmed to automatically identify the syringe model using information such as the outer casing diameter, core force, and blockage alarm settings.

The next stage of this document. One possible identification method is to identify the syringe by using a marking code printed on the jacket along with the syringe graduations.

The system specifies the injector and rated capacity, and uses this marking code to automatically program the pump. It is recommended that such a system be developed as soon as possible.

0.4 Selection of Infusion Rate and Nominal Syringe Capacity

The flow rates described in this document are for syringe testing purposes only and are not intended for clinical practice.

Typically, because flow accuracy depends on the linear stroke of the core/pump driver, syringes with smaller nominal capacity tend to have higher flow rates.

They have high resolution, and at slower speeds, they also tend to have high flow accuracy.

Disposable sterile syringes Part 2: Syringes for Power-Driven Injection Pumps

1 Scope

This document specifies the requirements for power-driven syringes with nominal capacities of 1 mL and above, made of polymer materials.

The requirement is for a power-driven syringe pump that is used in conjunction with a manufacturer-approved syringe pump.

This document does not apply to syringes with self-destruct mechanisms, insulin syringes, glass syringes, or syringes pre-filled with medication by the manufacturer.

This includes syringes used with the medication. This document does not address the compatibility of pump-operated syringes with the injected medication.

2 Normative references

The contents of the following documents, through normative references within the text, constitute essential provisions of this document. Dated citations are not included.

For references to documents, only the version corresponding to that date applies to this document; for undated references, the latest version (including all amendments) applies.

This document.

GB/T 6682 Specifications and test methods for water used in analytical laboratories (GB/T 6682-2008, ISO 3696:1987, MOD) GB 15810-2019 Disposable sterile syringes (ISO 7886-1:2017, MOD) ISO 80369-7 Small-bore connectors for medical fluids and gases – Part 7: Connectors for intravascular or subcutaneous applications

3 Terms and Definitions

The terms and definitions defined in GB 15810-2019 and the following terms and definitions apply to this document.

Braking position

The position of the piston inside the jacket before the user opens the packaging.

4 Naming

It should comply with the requirements of Chapter 4 of GB 15810-2019.

5 PH

It should comply with the requirements of 6.1 in GB 15810-2019.

6 Extractable metal content

It should comply with the requirements of 6.2 in GB 15810-2019.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 16 pages — is available in the English PDF.

Referenced standards

Normative references

ISO 3696 · ISO 7886 · ISO 80369

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