YY 1272-2016Dialysis fluid filter (English PDF)
透析液过滤器
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Issued by
NMPA
Level / Type
Industry · Mandatory
Issue date
March 23, 2016
Implementation date
January 1, 2018
Scope
YY 1272-2016 is the English-translated version of 透析液过滤器.
YY 1272-2016 is the Chinese pharmaceutical industry standard for the dialysis fluid filter, the hollow fibre filter used with a haemodialysis machine to remove endotoxin, micro-organisms and insoluble particles from the dialysis fluid.
It sets the requirements, the test methods, the inspection rules, the packaging identification and accompanying documents and the rules for packaging, transport and storage, covering the filtration performance and the retention of endotoxin and bacteria, the pressure the filter must withstand and its tightness, the flow resistance, the materials and their biological evaluation and sterility. Issued on 23 March 2016, it applies from 1 January 2018.
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Document preview — YY 1272-2016
National Standard of the People's Republic of China
- ICS
- 11.040.30
- Classification
- C 45
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- 1 Scope
- 2 Normative reference documents
- 3 Request
Foreword
The technical content of this standard is mandatory.
This standard is drafted in accordance with the rules given in GB/T 1.1-2009.
1 Scope
This standard specifies the requirements, test methods, inspection rules, packaging identification and random documentation, packaging, transportation and storage of dialysate filters.
This standard applies to dialysate filter, the product and hemodialysis device used in conjunction with its working principle is the use of hollow fiber membrane for Use, remove the endotoxin, microbiological and insoluble particles in the dialysate.
2 Normative reference documents
The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this document. For undated references, the latest edition (including all modifications) applies to this document.
GB/T 14233.1-2008 Methods of test for medical infusion, transfusion, and injectable utensils - Part 1. Chemical analysis methods
GB/T 14233.2-2005 Methods of examination for medical infusion, transfusion, and injectable utensils - Part 2. Biological test methods Biological evaluation of medical devices - Part 5. In vitro cytotoxicity test GB/T 16886.5
GB/T 16886.10 Biological evaluation of medical devices - Part 10. Stimulation and delayed type hypersensitivity Biological evaluation of medical devices - Part 11. Whole body toxicity test GB/T 16886.11 Disposable use of hollow fiber plasma separator Pharmacopoeia of the People's Republic of China (2).2010 edition
3 Request
3.1 Appearance
Dialysis fluid filter shell should be smooth surface, plastic uniform, no burr peak edge, the liquid channel must not be visible to the naked eye impurities.
3.2 Chemical properties of dialysate filters
3.2.1 Reduction of substances (easily oxidized)
20mL test solution and the same batch of blank liquid consumption of potassium permanganate solution [c (KMnO4) = 0.002mol/L] the difference between the volume should not exceed
3.2.2 Metal ions
3.2.2.1 Atomic Absorption Spectrophotometer (AAS) or equivalent method, the total content of barium, chromium, copper, lead and tin in the test solution shall Not more than 1µg/mL. Cadmium content should not exceed 0.1µg/mL.
3.2.2.2 Colorimetric analysis method. the color of the test solution should not exceed the mass concentration rho (Pb2) = 1µg/mL standard control solution.
3.2.3 pH
The difference between the test solution and the same batch of blank liquid should not exceed 1.5.
3.2.4 Evaporation of the residue
50mL test solution evaporation residue should not exceed 2mg.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 20 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 14233.1-2008Test methods for infusion, transfusion, injection equipments for medical use - Part 1: Chemical analysis methods
- GB/T 14233.2-2005Test methods for infusion, transfusion, injection equipment for medical use - Part 2: Biological test methods
- GB/T 16886.10Biological evaluation of medical devices - Part 10: Tests for skin sensitization
Similar standards
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Related Standards
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, injection equipment for medical use-Part 2: Biological test methods
GB/T 16886.10-2000 — Biological evaluation of medical devices--Part 10: Tests for irritation and sensitization
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YY 1272-2016
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