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YY/T 1272-2016 English PDF

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YY/T 1272-2016: DIalysis fluid filter
Status: Valid

YY/T 1272: Evolution and historical versions

Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusPDF
YY/T 1272-2016English219 Add to Cart 3 days [Need to translate] DIalysis fluid filter Valid YY/T 1272-2016
YY/T 1272-2016English219 Add to Cart 3 days [Need to translate] DIalysis fluid filter Valid YY/T 1272-2016

PDF similar to YY/T 1272-2016


Standard similar to YY/T 1272-2016

YY/T 1561   YY/T 1457   YY 1271   YY/T 1273   

Basic data

Standard ID YY/T 1272-2016 (YY/T1272-2016)
Description (Translated English) DIalysis fluid filter
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C45
Classification of International Standard 11.040.30
Word Count Estimation 10,193
Date of Issue 2016-03-23
Date of Implementation 2018-01-01
Issuing agency(ies) State Food and Drug Administration
Summary This standard specifies the requirements, test methods, inspection rules, packaging marks and accompanying documents, packaging, transportation and storage of dialysate filters. This standard applies to the dialysate filter, which is used in conjunction with hemodialysis equipment. Its working principle is to use the hollow fiber membrane to remove endotoxin, microorganisms and insoluble particles in the dialysate.

YY/T 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.
ICS 11:040:30 C45 Pharmaceutical Industry Standard of the People's Republic of China YY 1272-2016 Dialysate filter According to the State Drug Administration medical device industry Standard Announcement (No: 76 of 2022), this standard is from From September 7, 2022, it will be converted into a recommended standard, no Enforce it again: Released on March 23,:2016 2018-01-01 Implementation Issued by China Food and Drug Administration

foreword

All technical contents of this standard are mandatory: This standard is drafted in accordance with the rules given in GB/T 1:1-2009: Please note that some contents of this document may refer to patents: The issuing agency of this document assumes no responsibility for identifying these patents: This standard was proposed by China Food and Drug Administration: This standard is under the jurisdiction of the National Standardization Technical Committee of Medical Extracorporeal Circulation Equipment (SAC/TC158): This standard was drafted: State Food and Drug Administration Guangzhou Medical Device Quality Supervision and Inspection Center, Jinbao Kidney Care Products (Part 1) Sea) Co:, Ltd:, Braun Elton (Shanghai) Trading 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: YY 1272-2016 Dialysate filter

1 Scope

This standard specifies the requirements, test methods, inspection rules, packaging marks and accompanying documents, packaging, transportation and storage of dialysate filters: This standard applies to the dialysate filter, which is used in conjunction with hemodialysis equipment, and its working principle is to use the hollow fiber membrane as the Used to remove endotoxins, microorganisms and insoluble particles in the dialysate:

2 Normative references

The following documents are indispensable for the application of this document: For dated references, only the dated version applies to this document pieces: For undated references, the latest version (including all amendments) applies to this document: GB/T 14233:1-2008 Test methods for medical infusion, blood transfusion and injection equipment Part 1: Chemical analysis methods GB/T 14233:2-2005 Test methods for medical infusion, blood transfusion and injection equipment Part 2: Biological test methods GB/T 16886:5 Biological evaluation of medical devices - Part 5: Cytotoxicity test in vitro GB/T 16886:10 Biological evaluation of medical devices - Part 10: Irritation and delayed hypersensitivity GB/T 16886:11 Biological evaluation of medical devices - Part 11: Systemic toxicity test YY 0465-2009 Disposable hollow fiber plasma separator Pharmacopoeia of the People's Republic of China (Part Two):2010 Edition

3 requirements

3:1 Appearance The shell of the dialysate filter should have smooth surface, uniform plasticization, no burrs and peaks, and there should be no impurities visible to the naked eye in the liquid channel: 3:2 Chemical properties of the dialysate filter 3:2:1 Reducing substances (easy to oxidize) The difference in the volume of potassium permanganate solution [c(KMnO4)=0:002mol/L] consumed by the 20mL test solution and the same batch of blank solution should not exceed 2:0mL: 3:2:2 Metal ions 3:2:2:1 When the atomic absorption spectrophotometer (AAS) or equivalent method is used for determination, the total content of barium, chromium, copper, lead and tin in the test solution shall be Not more than 1 μg/mL: The content of cadmium 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 pH difference between the test solution and the same batch of blank solution should not exceed 1:5: 3:2:4 Evaporation residue The total amount of evaporation residue in 50mL test solution should not exceed 2mg: YY 1272-2016

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Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version YY/T 1272-2016 even if the enforcement date is in future. Complying with the latest version means that, by default, it also complies with all the earlier versions, technically.