1 Scope
This part of YY 0321 specifies the requirements of single-use filter for anesthesia.
This part is applicable to single-use filter for anesthesia (hereinafter referred to as filter) which is used in combination with single-use puncture needle for anesthesia.
2 Normative Reference
The following normative documents contain provisions which, through reference in this text, constitute provisions of this standard. For dated references, subsequent amendments to (excluding amending errors in the text), or revisions of, any of these publications do not apply. However, all parties coming to an agreement according to this standard are encouraged to study whether the latest edition of the normative document is applicable. For undated references, the latest edition of the normative document applies.
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 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/T 16886.1 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing
YY 0466 Medical Devices - Symbols to be Used with Medical Device Labels Labeling and Information to be Supplied
3 Classification and Labeling
3.1 Classification
Filters are classified into air filters and chemical liquid filters.
3.2 Structural type
Foreword I
1 Scope
2 Normative Reference
3 Classification and Labeling
4 Materials
5 Physical Requirements
6 Chemical Requirements
7 Biological Requirements
8 Marking
Appendix A (Normative) Physical Test
Appendix B (Normative) Rule for Type Inspection
