YY/T 0921-2015 English PDFUS$259.00 ยท In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 0921-2015: Medical absorbent viscose wadding Status: Valid
Basic dataStandard ID: YY/T 0921-2015 (YY/T0921-2015)Description (Translated English): Medical absorbent viscose wadding Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended) Classification of Chinese Standard: C48 Classification of International Standard: 11.120.20 Word Count Estimation: 12,173 Date of Issue: 2015-03-02 Date of Implementation: 2016-01-01 Quoted Standard: GB/T 14233.1; GB/T 19973.1; YY/T 0615.1 Regulation (derived from): The State Food and Drug Administration Announcement 2015 No. 8 Issuing agency(ies): State Food and Drug Administration Summary: This Standard specifies requirements for medical-absorbent viscose fibers and test methods. This Standard applies to recycled fiber cable by a new production of viscose fiber, bleached, careless treatment from substance does not contain any added medical-absorbent colored viscose fibers. Medical-absorbent Absorbent viscose fiber alternative use. YY/T 0921-2015: Medical absorbent viscose wadding---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.Medical absorbent viscose wadding ICS 11.120.20 C48 People's Republic of China pharmaceutical industry standards Medical-absorbent viscose fiber Issued on. 2015-03-02 2016-01-01 implementation China Food and Drug Administration released ForewordThis standard was drafted in accordance with GB/T 1.1-2009 given rules. This standard reference the 2010 edition of the British Pharmacopoeia "water-absorbing viscose fiber." Please note that some content of this document may involve patents, the issuing authority of this document does not assume responsibility for the identification of these patents. This standard was proposed by the China Food and Drug Administration. This standard by the State Food and Drug Administration Jinan Medical Device Quality Supervision and Inspection Center. This standard is drafted by. Shandong Medical Devices Product Quality Inspection Center. Participated in the drafting of this standard. Henan floating the Group Co., Ltd. The main drafters of this standard. Like Fang, Zhang Limei, Guo Lun, Sun Haipeng, Wang Jiyong, Fan Xiangyang.IntroductionViscose or medical dressings containing adhesives have been widely used in foreign countries. Medical-absorbent Absorbent viscose fiber alternative for hospital clinical Use for cleaning wounds, wipe, skin disinfection. Separable sterile and non-sterile supplies supply. Due to the high adsorption, if sterilized with ethylene oxide, propylene oxide and their patients sick officer adsorbed lead to higher risk Damage, therefore, this standard does not recommend the use of ethylene oxide sterilization of medical-absorbent viscose fiber. For water-absorbent viscose non-sterile medical supplies Fiber manufacturer bioburden to determine the sterilization parameters sterilization as a medical institution basis. Medical-absorbent viscose fiber1 ScopeThis standard specifies requirements for medical-absorbent viscose fiber and test methods. This standard applies to viscose production by new regenerated cellulose fibers, bleached, crude without any treatment from colored to add Medical-absorbent material viscose fibers. Medical-absorbent cotton viscose fiber alternative medical use.2 Normative referencesThe following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document. GB/T 14233.1 Infusion, transfusion, injection equipment - Part 1. Chemical analysis GB/sterilization Microbiological methods - Part 1 T 19973.1 medical equipment. the total number of microorganisms on the product estimate YY/T 0615.1 labeling requirements "sterile" medical devices - Part 1. terminally sterilized medical devices People's Republic of China Pharmacopoeia3 Terms and DefinitionsThe following terms and definitions apply to this document. 3.1 New fiber produced by the viscose regenerated cellulose, bleached, careless treatment, with or without additives of titanium dioxide, a linear density 1.0dtex ~ 8.9dtex (mass 1dtex = 10000m fiber unit. g) and cut to the appropriate length of the fiber. It does not contain any non-ferrous Adding substance.4 Requirements4.1 Characters White or slightly yellow, shiny or matte appearance, soft touch. 4.2 Identification The test results should meet the 5.3. PH 4.3 By 5.4 test, there should be no solution was pink. 4.4 foreign fibers When examined under a microscope, it should only contain viscose, occasionally a small amount of foreign fibers exist in isolation. 4.5 phosphors 5.5 press test, medical-absorbent viscose fibers should only brown purple fluorescence microscopy. In addition to the small number of isolated fiber, should not significantly strong blue fluorescence. ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 0921-2015_English be delivered?Answer: Upon your order, we will start to translate YY/T 0921-2015_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. The lengthier the document the longer the lead time.Question 2: Can I share the purchased PDF of YY/T 0921-2015_English with my colleagues?Answer: Yes. 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