YY 1001-2024
Glass syringes (English Version)
- Standard No.
- YY 1001-2024
- Language
- Chinese, Available in English version
- Release Date
- 2024
- Published By
- Professional Standard - Medicine
- Latest
- YY 1001-2024
- Replace
- YY 1001.1-2004 YY 1001.2-2004
- Introduction
Background of Standard Revision and Technological Evolution
YY 1001-2024 replaces the two sub-standards of the 2004 version, integrating the technical requirements for all-glass syringes and blue core all-glass syringes. The main technical changes include:
- Added jacket trimming structural requirements (Clause 6.17)
- Deleted outdated clauses such as matching codes and inspection rules
- Optimized tightness test parameters (Table 5)
Comparison of core technical requirements
Technical indicators 2004 version requirements 2024 version changes Capacity tolerance ±5% Optimized to ±3%-4% (Table 3) Fitness test 150-300kPa Gradual pressure setting (Table 5) Residual liquid volume Unspecified New quantitative indicators (Table 6)
Key performance test methods
6.4 Capacity tolerance test
Use the weighing method or standard glass measuring instrument method. The test points include:
- Nominal capacity
- 20% nominal capacity (when there is no main graduation line, take the nearest secondary graduation line)
6.10 Cone head tightness test
Use a plug gauge that complies with GB/T 1962.1 and maintain it under 300kPa water pressure for 30 seconds. The requirements are:
- No leakage between the cone head and the needle seat
- Clean and dry before testing
Material and structural specifications
5. Material requirements
Must use borosilicate aluminum glass, its characteristics include:
- Thermal expansion coefficient ≤5×10-6/K
- Hydrolysis resistance ≥HC1 grade
- Stress after annealing ≤ orange-red (Clause 6.12)
4. Structural form
New Cut edge structure requirements (Figure 1 No. 12):
- Special treatment is required at the opening at the end of the jacket
- Should not rotate 180° when placed on a 10° inclined plane
Clinical application recommendations
Negative pressure detection application
The standard clearly encourages the application of the technical indicators of this document to the negative pressure detection syringe for epidural anesthesia. Special attention should be paid to:
- 2mL and above specifications should be preferred
- The cone head tightness should meet the 300kPa requirement
- It is recommended to increase the initial contamination bacteria detection
Cleanliness control
Refer to Appendix B for recommendations, and the following need to be monitored:
- Glass residue: no visible foreign matter by visual inspection
- Particle contamination: ≤50μm particle number
- Endotoxin: ≤0.25EU/mL
Key points for implementation of the standard
Implementation links Critical control points Transition period recommendations Manufacturing Trimming process verification
Borosilicate aluminum glass raw material testingComplete production line transformation before 2025 Quality inspection Add residual liquid volume test
Fitness grading testEstablish SOP for detection methods Clinical use Sterilization method confirmation
Cleanliness evaluationCreate records according to Appendix B
YY 1001-2024 Referenced Document
- GB/T 1962.1 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment.Part 1:General requirement
- YY 91017 Test method of leakage between barrel and plunger of medical glass syringes
YY 1001-2024 history
- 2024 YY 1001-2024 Glass syringes
- 2004 YY 1001.2-2004 Glass syringes-Part 2:Blue syringes with all-glass
- 0000 YY 91061-1999
