YY 1272-2016 English PDF

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YY 1272-2016: Dialysis fluid filter
Status: Obsolete

YY 1272: Historical versions

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY 1272-2016	399	Add to Cart	3 days	Dialysis fluid filter	Obsolete
YY/T 1272-2016	219	Add to Cart	3 days	DIalysis fluid filter	Valid

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Basic data

Standard ID: YY 1272-2016 (YY1272-2016)
Description (Translated English): Dialysis fluid filter
Sector / Industry: Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard: C45
Classification of International Standard: 11.040.30
Word Count Estimation: 10,178
Date of Issue: 2016-03-23
Date of Implementation: 2018-01-01
Quoted Standard: GB/T 14233.1-2008; GB/T 14233.2-2005; GB/T 16886.5; GB/T 16886.10; GB/T 16886.11; YY 0465-2009
Regulation (derived from): Notice of the General Administration of Food and Drug Administration (No. 74 of 2016)
Issuing agency(ies): State Food and Drug Administration
Summary: This standard specifies the requirements, test methods, inspection rules, packing marks and random documents, packaging, transportation and storage of dialysis fluid filters. This standard applies to dialysis fluid filter, the product and hemodialysis device with the use of its working principle is the use of hollow fiber membrane, the removal of dialysate in endotoxin, emblem and insoluble particles emblem.

YY 1272-2016: Dialysis fluid filter

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Dialysis fluid filter ICS 11.040.30 C45 People's Republic of China Pharmaceutical Industry Standard Dialysis fluid filter 2016-03-23 release 2018-01-01 implementation State Food and Drug Administration issued

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. Please note that some of the contents of this document may involve patents. The issuer of this document does not assume responsibility for the identification of these patents. This standard is proposed by the State Food and Drug Administration. This standard by the National Medical Extracorporeal Circulation Equipment Standardization Technical Committee (SAC/TC158) centralized. The drafting unit. the State Food and Drug Administration Guangzhou Medical Device Quality Supervision and Inspection Center, Jinbao kidney care products (on (Shanghai) Co., Ltd., Fresenius Medical Supplies (Shanghai) Co., Ltd. The main drafters of this standard. Wu Jingbiao, Tian Liyan, He Xiaofan, Cui Yang, Shi Huimin, Yu Qinghong. Dialysis fluid filter

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 article Pieces. 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 2.0 mL. 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 ρ (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. ......

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