YY/T 0614-2017Single-use high-pressure angiographic syringes and accessories (English PDF)

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009.

This standard replaces YY/T 0614-2007 "Single-use high-pressure angiographic syringes and accessories". As compared with YY/T 0614-2007, in addition to editorial changes, the main technical changes of this standard are as follows.

- ADD the 88 kPa negative pressure adhesion requirements of the angiographic syringe;

- MODIFY the cork piercer requirements;

- MODIFY the air intake device requirements;

- ADD anti-reflux valve requirements and test methods;

- REVISE the adhesion test method;

- ADD a single package identifier;

- ADD a shelf package or multi-unit packaging identifier;

- DELETE the Appendix A Particle content determination method from the original standard, the particle content determination method makes reference to the test method as given in YY/T 1556-2017 Test methods for particle contamination of infusion, transfusion and injection equipment for medical use which is formulated at the period;

- MODIFY the chemical test solution preparation method.

1 Scope

This standard specifies the requirements for the single-use high-pressure angiographic syringes and accessories (hereinafter referred to as angiographic syringes). The angiographic syringe is mainly used by the medical department to perform digital subtraction angiography (DSA), computer-controlled tomography (CT), magnetic resonance imaging (MRI), and ultrasound (US) examinations, together with various types of high-pressure injection device.

This standard does not include requirements for endovascular catheters and related guidance puncture devices.

2 Normative references

The following documents are essential to the application of this document. For the dated documents, only the versions with the dates indicated are applicable to this document; for the undated documents, only the latest version (including all the amendments) are applicable to this standard.

GB/T 1962.1 Conical fittings with a 6%(Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirement

GB/T 1962.2 Conical fittings with a 6%(Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings

GB 15810 Sterile hypodermic syringes for single use

YY/T 0466.1-2009 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements

YY 0585.4-2009 Fluid lines for use with pressure infusion equipment and accessories for single use - Part 4: Check valves

3 Product type

Figure 1 ~ Figure 3 show the schematic diagrams of the structures of common angiographic syringes and accessories (inhalers, connecting lines, etc.).

4 Product marking

Products marking is composed of product literal expression, this standard number, applicable angiographic imaging techniques code [such as computer-controlled X-ray tomography (CT), digital subtraction angiography (DSA), magnetic resonance imaging (MRI), ultrasound (US), etc.], injection equipment

5 Materials

The materials used for the angiographic syringe and the parts given in clause 3 shall comply with the requirements of clause 6.

6 Physical requirements

7 Chemical requirements

The provisions of GB 15810 apply to angiographic syringes and accessories, but the preparation method of test liquids is in accordance with Appendix B.

8 Biological requirements

The provisions of GB 15810 apply to angiographic syringes and accessories.

9 Markings

10 Packaging

10.1 Angiographic syringes and/or accessories shall be packaged in set or individually packaged, the packaging shall ensure that the contents remain sterile during the storage period. After opening the single package, there shall be open signs.