1 Scope
This standard specifies the technical requirements of dispensing syringe for single use (hereinafter referred to as syringe).
This standard is applicable to syringes used for clinically extracting or preparing pharmaceuticals.
2 Normative References
The following documents are essential for the application of this document. For dated references, only the edition cited applies. For undated references, the latest editions (including all amendments) are applicable to this document.
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 The Conical Fittings with a 6% (Luer) Taper For Syringes, Needles and Certain Other Medical Equipment - Part 2: Lock Fittings
GB/T 6682 Water for Analytical Laboratory Use-Specification and Test Methods
GB 8368 Infusion Sets for Single Use - Gravity Feed
GB/T 14233.1 Test Methods for Infusion, Transfusion, Injection Equipment for Medical Use - Part 1: Chemical Analysis Methods
GB/T 14233.2 Test Methods for Infusion, Transfusion, Injection Equipment for Medical Use - Part 2: Biological Test Methods
GB 15810 Sterile Hypodermic Syringes for Single Use
GB 15811 Sterile Hypodermic Needles for Single Use
GB/T 16886.1 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing
GB 18278 Sterilization of Health Care Products - Requirements for Validation and Routine Control - Industrial Moist Heat Sterilization
GB 18279 Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization
GB 18280 Sterilization of Health Care Products - Requirements for Validation and Routine Control - Radiation Sterilization
GB 18457 Stainless Steel Needle Tubing for Manufacture of Medical Devices
GB 18671 Intravenous Needles for Single Use
YY/T 0243 Plunger of Sterile Syringes for Single Use
YY/T 0296 Hypodermic Needles for Single Use - Colour Coding for Identification
YY/T 0466.1 Medical Devices - Symbols to be Used with Medical Device Labels Labelling and Information to be Supplied - Part 1: General Requirements
ISO 7864: 1993 Sterile Hypodermic Needles for Single Use
ISO 8536-2 Infusion Equipment for Medical Use - Part 2: Closures for Infusion Bottles
3 Terms and Definitions
For the purpose of this standard, the following terms and definitions apply.
3.1
Nominal capacity
Capacity of the syringe as designated by the manufacturer.
Note: e.g. 20mL and 30mL.
3.2
Foreword I
1 Scope
2 Normative References
3 Terms and Definitions
4 Classification and Nomenclature
5 Requirements
6 Mark
7 Storage
Appendix A (Normative) Test Methods for Particle Pollution
Appendix B (Normative) Test Methods for Puncture Exfoliation
Appendix C (Normative) Preparation Method for Extraction Solution
Appendix D (Informative) Materials Guideline
