1 Scope
This standard specifies classification and marking, materials, physical, chemical and biological requirements, marking and packaging of single-use filter for syringe.
This standard is applicable to single-use filter for syringe (hereinafter referred to as filter); the filter, used together with syringe, is applied to muscle injection and intravenous injection of medicine in clinical treatment, addition of medicine to liquid bottle, and filtration of insoluble particles in chemical liquid.
2 Normative References
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the normative document (including any amendments) applies.
GB/T 1962.1 The 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 14233.1-2008 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/T 16886.1 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process
YY 0321.3 Single-use Filter for Anesthesia
YY/T 0466.1 Medical Devices - Symbols to be Used with Medical Device Labels Labelling and Information to be Supplied - Part 1: General Requirements
YY 0770.1 Filter Material for Medical Infusion Equipment - Part 1: Fluid Filter Material
3 Classification and Marking
Foreword I
1 Scope
2 Normative References
3 Classification and Marking
4 Materials
5 Physical Requirements
6 Chemical Requirements
7 Biological Requirements
8 Marking
9 Package
Appendix A (Normative Appendix) Physical Test
Appendix B (Normative Appendix) Rules for Inspection Test
