Detail of YY/T 0821-2010

Introduction of YY/T 0821-2010

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

Contents of YY/T 0821-2010

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