YY/T 0308-2015 PDF EnglishUS$150.00 · In stock · Download in 9 seconds
YY/T 0308-2015: Medical sodium hyaluronate gel Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedure Status: Valid YY/T 0308: Historical versions
Similar standardsYY/T 0308-2015: Medical sodium hyaluronate gel---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YYT0308-2015YY PHARMACEUTICAL INDUSTRY STANDARD ICS 11.120.20 C 48 Replacing YY/T 0308-2004 Medical sodium hyaluronate gel Issued on. MARCH 2, 2015 Implemented on. JANUARY 1, 2016 Issued by. China Food and Drug Administration Table of ContentsForeword... 3 Introduction... 5 1 Scope... 7 2 Normative references... 7 3 Terms and definitions... 7 4 Classification... 8 5 Requirements... 8 6 Inspection rules... 12 7 Marks... 12 8 Packaging... 13 Appendix A... 14 Appendix B... 17 Appendix C... 19 Appendix D... 21 References... 23ForewordThis Standard was drafted in accordance with the rules given in GB/T 1.1-2009. This Standard replaces YY 0308-2004 Medical sodium hyaluronate gel. Compared with YY 0308-2004, the main technical changes are as follows. - Added terms, definitions and requirements for shear viscosity, elasticity, viscoelastic and weight average molecular weight (see 3.2~3.5, 5.8, 5.9, 5.10.2 of this edition); - Deleted dynamic viscosity’s terms, definitions and requirements (3.2 of this edition; 5.8 of 2004 edition); - Modified requirements for effective usage (see 5.2 of this edition; 5.2 of 2004 edition); - Modified requirements for light transmittance (see 5.5 of this edition; 5.5 of 2004 edition); - Modified requirements for protein content (5.11 of this edition; 5.10 of 2004 edition); - Added requirements for refractive index (see 5.13 of this edition); - Modified ethanol residues indicator (see 5.15 of this edition; 5.13 of 2004 edition); - Modified bacterial endotoxin Indicator (see 5.17 of this edition; 5.15 of 2004 edition); - Deleted description on biological test methods (5.17.2~5.17.7 of 2004 edition); - Modified method for the determination of sodium hyaluronate (see Appendix A of this edition; Appendix A of 2004 edition). Please note that some of the content of this document may involve patents; the issuing agency of this document does not undertake the responsibility for the identification of these patents. This Standard was proposed by China Food and Drug Administration. This Standard shall be under the jurisdiction of Shandong Food and Drug Administration of China Food and Drug Administration. The drafting organizations of this Standard. Shanghai Qisheng Biological Agents Ltd., Shandong Quality Inspection Center for Medical Devices, and Shandong Freda Biotechnology Co., Ltd. Main drafters of this Standard. Wang Wenbin, Jiang Lixia, Shen Yong, Liu Lili, Liu Ye, Guo Xueping, and Mu Shue. This Standard was issued in October, 1998 for the first time, and amended in November, 2004.This edition is the second revision.1 ScopeThis Standard specifies the classification, requirements, inspection rules, marks and packaging of medical sodium hyaluronate gel. This Standard is applicable to medical sodium hyaluronate gel. The application of medical sodium hyaluronate gel includes viscoelastic agents for eye surgery, lubricants for intra-articular injection and barriers for surgical operation.2 Normative referencesThe following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. GB/T 16886.1 Biological evaluation of medical devices - Part 1.Evaluation and testing within a risk management process Pharmacopoeia of the People's Republic of China 2010 English Edition, 2 Volumes3 Terms and definitionsThe following terms and definitions apply to this document. 3.1 medical sodium hyaluronate gel Gel-like solution formulated with sodium hyaluronate and for human. 3.2 shear viscosity Ability to resist deformation rate of fluid by shear force. 3.3 elasticity After the material is deformed by an external force, the external force is removed to restore nature to its original shape.4 Classification4.1 Medical sodium hyaluronate gel is divided by clinical applicability into. for ophthalmic use, for surgical use and for intra-articular injection use. 4.2 Medical sodium hyaluronate gel is generally divided according to product packaging specifications into.5 Requirements5.1 Appearance According to Appendix IX H of Pharmacopoeia of the People's Republic of China 2010 English Edition, 2 Volumes, 5.2 Effective usage Try to take out the content in each single package in normal used method. After accurately weighed, it is divided by medical sodium hyaluronate gel density (ρ = 1.01 g/mL), the obtained value shall not be less than 93% of the labelled amount, and the average value shall not be less than the labelled amount. 5.3 Identification Medical sodium hyaluronate gel shall have the following reactions. 5.4 Content Determine it according to the method stipulated in Appendix A and the sodium hyaluronate content should be 90.0%~120.0% of the labelled mass concentration. 5.5 Light transmittance Use sodium chloride solution of which the concentration is 9 g/L for 10-fold dilution of medical sodium hyaluronate gel. Take preparation solution as blank control. 5.6 pH Use distilled water for equivalent mass ration dilution of medical sodium hyaluronate gel. Determine pH according to the method stipulated in Appendix VI H of Pharmacopoeia of the People's Republic of China 2010 English Edition, 2 Volumes, and pH shall be within 6.8~7.6. 5.9 Elasticity For sodium hyaluronate used for ophthalmology and intra-articular, it shall use rheometer to conduct frequency scan at shear rate of 0.01 Hz ~ 100 Hz at (25±0.2)°C. Draw logarithmic line graphs of viscous modulus G" and elastic modulus G' and logarithmic line graph of frequency. The shear frequency corresponding to G" = G' shall be less than the labelled value. 5.10 The average molecular weight 5.10.2 Weight average molecular weight and molecular weight distribution factor 5.11 Protein content Determine in the method stipulated in Appendix C. The protein content in sodium hyaluronate shall not be greater than 0.1% (mass fraction). 5.15 The residual amount of ethanol Determine in the method stipulated in Appendix D. The residual amount of ethanol in medical sodium hyaluronate gel shall not be greater than 200 µg/g. 5.16 Sterility Inspect in the method stipulated in Appendix XI H of the People's Republic of China 2010 English Edition, 2 Volumes. Medical sodium hyaluronate gel should be sterile. 5.17 Bacterial endotoxin Use bacterial endotoxin test water to dilute the medical sodium hyaluronate gel. Inspect by the method stipulated in Appendix XI E of the People's Republic of China 2010 English Edition, 2 Volumes. Bacterial endotoxin per milliliter of medical sodium hyaluronate gel shall be less than 0.5 EU.6 Inspection rules6.1 Group-batch Medical sodium hyaluronate gel feed of same batch shall be produced in same feeling and same technology. 6.2 Type inspection7 Marks7.1 The following marks shall be on the bulk packaging. 7.2 The following marks shall be on the small packaging or accompanying documentation.8 PackagingIt shall use a dose packaging for the small packaging of medical sodium hyaluronate gel shall use. Packaging design of convenient use is preferred. ......Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al. Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of English version of YY/T 0308-2015 be delivered?Answer: The full copy PDF of English version of YY/T 0308-2015 can be downloaded in 9 seconds, and it will also be emailed to you in 9 seconds (double mechanisms to ensure the delivery reliably), with PDF-invoice.Question 2: Can I share the purchased PDF of YY/T 0308-2015_English with my colleagues?Answer: Yes. The purchased PDF of YY/T 0308-2015_English will be deemed to be sold to your employer/organization who actually paid for it, including your colleagues and your employer's intranet.Question 3: Does the price include tax/VAT?Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countriesQuestion 4: Do you accept my currency other than USD?Answer: Yes. www.ChineseStandard.us -- YY/T 0308-2015 -- Click this link and select your country/currency to pay, the exact amount in your currency will be printed on the invoice. Full PDF will also be downloaded/emailed in 9 seconds.Question 5: Should I purchase the latest version YY/T 0308-2015?Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version YY/T 0308-2015 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.How to buy and download a true PDF of English version of YY/T 0308-2015?A step-by-step guide to download PDF of YY/T 0308-2015_EnglishStep 1: Visit website https://www.ChineseStandard.net (Pay in USD), or https://www.ChineseStandard.us (Pay in any currencies such as Euro, KRW, JPY, AUD).Step 2: Search keyword "YY/T 0308-2015". Step 3: Click "Add to Cart". If multiple PDFs are required, repeat steps 2 and 3 to add up to 12 PDFs to cart. Step 4: Select payment option (Via payment agents Stripe or PayPal). Step 5: Customize Tax Invoice -- Fill up your email etc. Step 6: Click "Checkout". Step 7: Make payment by credit card, PayPal, Google Pay etc. After the payment is completed and in 9 seconds, you will receive 2 emails attached with the purchased PDFs and PDF-invoice, respectively. Step 8: Optional -- Go to download PDF. Step 9: Optional -- Click Open/Download PDF to download PDFs and invoice. See screenshots for above steps: Steps 1~3 Steps 4~6 Step 7 Step 8 Step 9 |
