1 Scope
This standard specifies requirements, test methods, inspection rules, package marking and accompanying documents, packaging, transportation and storage for dialysis fluid filter.
This standard is applicable to the dialysis fluid filter. This product is used in conjunction with a hemodialysis device. Its working principle is to utilize the function of hollow fiber membrane, to remove endotoxin, microorganisms and insoluble particles from the dialysate.
2 Normative References
The following documents for the application of this document is essential. For dated references, only the edition cited applies. For undated reference, the latest edition (including all the amendments) applies.
GB/T 14233.1-2008 Test Methods for Infusion, Transfusion, Injection Equipment for Medical Use--Part 1: Chemical Analysis Methods
GB/T 14233.2-2005 Test Methods for Infusion, Transfusion, and Injection Equipment for Medical Use--Part 2: Biological Test Methods
GB/T 16886.5 Biological Evaluation of Medical Devices--Part 5: Test for in Vitro Cytotoxicity
GB/T 16886.10 Biological Evaluation of Medical Devices--Part 10: Irritation and Delayed-Type Hypersensitivity
GB/T 16886.11 Biological Evaluation of Medical Devices--Part 11: Tests for Systemic Toxicity
YY 0465-2009 Single Use Hollow Fiber Plasma Separator
Pharmacopoeia of People’s Republic of China (Part II), Edition 2010
3 Requirements
3.1 Appearance
The outer surface of dialysis fluid filter shall be smooth, plasticized, and free of burr peaks, and there must be no visible impurities in the liquid passage.
3.2 Chemical properties of dialysis fluid filter
3.2.1 Reducing substance (readily oxidizable substance)
Foreword i
1 Scope
2 Normative References
3 Requirements
4 Test Methods
5 Inspection Rules
6 Package Marking and Accompanying Documents
7 Packaging, Transportation and Storage
Annex A (Informative) Inspections of Microbial Limit and Endotoxin
