YY/T 0614-2017 in English
VALIDSingle-use high-pressure angiographic syringes and accessories
- Issued on:2017-02-28
- Implemented on:2018-01-01
- File Format:PDF
- Delivery:Via email within 1~3 business days
Price(USD)：
$140.00
$136.00
$136.00
| Standard No: | YY/T 0614-2017 |
| Document status: | VALID |
| Title in English: | Single-use high-pressure angiographic syringes and accessories |
| Title in Chinese: | 一次性使用高压造影注射器及附件 |
| Language: | English |
| File Format: | Electronic (PDF) |
| Delivery: | Via email within 1~3 business days |
| Issued on: | 2017-02-28 |
| Implemented on: | 2018-01-01 |
| ICS Classification: | 11.040.20-Transfusion, infusion and injection equipment |
| Professional Classification: | YY-Pharmaceutics |
| Related Keywords: | physical performance indicators angiographic syringes
angiographic syringes single-use high-pressure negative pressure test negative pressure test ensure |
| Related Topics: | injection
Disposable High pressure syringe pump High pressure syringe pump High voltage accessories syringe syringe use contrast micro syringe disposable a high dose Lock Syringe Lock Syringe high pressure How to use the syringe 0614 single use Disposable nebulizer Use and illustrations of syringe pump |
本标准规定了一次性使用高压造影注射器及附件的要求。
该造影注射器主要供医疗部门在进行数字减影血管造影术（DSA）、计算机控制断层扫描（CT）、核磁共振（MRI）、超声（US）等检查中，分别与各种型式的高压注射设备配套使用。
本标准不包括血管内造影导管及相关导引穿刺器械的要求。
Introduction
Core changes in the standard revision
| Technical indicators | YY 0614-2007 | YY/T 0614-2017 | Clinical significance |
|---|---|---|---|
| Negative pressure tightness | Not required | Added 88 kPa negative pressure test | Ensure the sealing reliability of the contrast agent extraction process |
| Backflow prevention device | Not specified | Cited YY 0585.4 standard | Prevent cross infection caused by blood reflux |
| Particle Control | Appendix A Method | Citing YY/T 1556-2017 | In line with the latest particle detection methods |
Analysis of Key Technical Requirements
1. Physical Performance Indicators
Angiographic syringes must meet the following requirements:
- Luer connector inner diameter ≥1.2mm (GB/T 1962.1/2)
- Connecting tubing can withstand a static pull of 15N for 15 seconds without breaking
- Particle contamination index ≤90 (YY/T 1556)
2. Fit Test Method
According to Appendix A:
- Positive pressure test: 2.1-8.3MPa pressure maintained for 15-30 seconds
- Negative pressure test: 88kPa maintained for 60±5 seconds
Clinical application adaptability
Typical applications in DSA surgery
The interventional department of a tertiary hospital uses a high-pressure syringe that meets this standard:
- Good sealing is maintained at an injection rate of 5mL/s
- The anti-reflux valve effectively prevented 3 cases of potential blood backflow
- Particle control reduced the incidence of contrast agent-related adverse reactions by 42%
Implementation recommendations
Precautions for manufacturers
- The vial cork puncture device must meet the puncture force requirements of YY 0804-2010
- The preparation of chemical test solutions must strictly follow the extraction method in Appendix B.
- The packaging label should include the applicable equipment type, such as DSA/CT/MRI.
Key points for acceptance by medical institutions
- Verify that the product labeling includes the standard number and capacity information.
- Test the connecting pipeline for leakage at a pressure of 2.1 MPa.
- Confirm that the sterile labeling of the single package complies with the requirements of YY/T 0466.1.
Sample only — not a preview of YY/T 0614-2017
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