YY/T 1293.5-2017 PDF EnglishUS$150.00 · In stock · Download in 9 seconds
YY/T 1293.5-2017: Contacting wound dressing - Part 5: Alginate dressing 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 1293.5: Historical versions
Similar standardsYY/T 1293.5-2017: Contacting wound dressing - Part 5: Alginate dressing---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/YYT1293.5-2017YY PHARMACEUTICAL INDUSTRY STANDARD ICS 11.120.20 C 31 Contacting wound dressing - Part 5.Alginate dressing Issued on: MAY 2, 2017 Implemented on: APRIL 3, 2018 Issued by. China Food and Drug Administration Table of ContentsForeword... 3 Introduction... 4 1 Scope... 5 2 Normative references... 5 3 Classification... 6 4 Requirements... 6 5 Biocompatibility... 7 6 Test methods... 7 7 Marks... 10 8 Packaging... 10 Annex A (informative) Infrared identification map of alginate... 12 Contacting wound dressing - Part 5.Alginate dressing1 ScopeThis Part of YY 1293 specifies the performance requirements and test methods for alginate dressing. This Part is applicable to aseptically supplied alginate dressing that consists only of alginate fibres. This Part does not include requirements for alginate dressing containing silver and other bacteriostatic agents.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 6682, Water for analytical laboratory use - Specification and test methods GB/T 16886.1, Biological evaluation of medical devices - Part 1.Guidance on selection of tests YY/T 0466.1, Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1.General requirements YY/T 0471.1-2004, Test methods for primary wound dressing - Part 1. Aspects of absorbency YY/T0615.1, Requirements for medical devices to be designated STERILE - Part 1.Requirements for terminally sterilized medical devices Pharmacopoeia of People's Republic of China (Edition 2010) ISO 11607-1.2006, Packaging for terminally sterilized medical devices - Part 1.Materials, sterile barrier systems and packaging systems 1 1 The standard corresponding to ISO 11607-1 is GB 19633.The latest version has been submitted for approval. Please pay attention to the publication. 6.2 Identification test 6.2.1 Extract fiber from alginate dressing for infrared identification based on the reference to Annex A. The result shall be substantially the same as or in between the two spectra of the alginate G infrared absorption spectrum or the alginate M infrared absorption spectrum. 6.2.2 Weigh 5.0 mg of alginate dressing. Add 5mL of water, 1mL of freshly prepared 1% of 1,3 dihydroxynaphthalene ethanol solution, 5mL of hydrochloric acid, boil 3min and cool. Add 5mL of water. Extract with 15 mL of diisopropyl ether. The dark purple in the upper layer shall be deeper than the blank made in the same method. 6.2.3 Weigh 0.1g of alginate dressing. Add 5mL of water, boil, the sample shall not dissolve. Add 2mL of 10% sodium carbonate solution to generate white precipitate. Perform centrifugation and acidification to generate gelatinous precipitate. 6.3 Loss on drying Take 0.5g of alginate dressing. Conduct the test according to Annex VIII L in Part II of Pharmacopoeia of People's Republic of China (Edition 2010). 6.4 pH test Cut 1.0g of sample into about 1cm2 pieces. Put into a suitable container. Add 50mL of water. Seal at 37°C ± 1°C to soak 24h. Pour the liquid gently, mix, and obtain the test solution. Determine the pH of the test solution and blank solution with a pH meter. The difference of these two shall be inspection results. 6.5 Ignition residue test Take 1.0g of alginate dressing. Conduct the test according to Annex VIII N Ignition residue inspection method (500°C~600°C) in Part II of Pharmacopoeia of People's Republic of China (Edition 2010). 6.6 Heavy metal test Take residue left under 6.5.Perform according to Annex VIII H Heavy metal inspection method in Part II of Pharmacopoeia of People's Republic of China (Edition 2010). NOTE Add 2mL of acetate buffer (pH3.5). After slight heat dissolution, if there is precipitation, filtrate it and then move to Nessler colorimetric tube. 6.7 Iron content test Take 1.0g of alginate dressing. Slow bake at 500°C~600°C till complete carbonization. Let it cool. After adding 4 mL of hydrochloric acid to dissolve it, transfer it to a 50 mL volumetric flask. Add water to the scale, shake, and accurately measure 5mL. Perform according to Annex VIII G Iron salt inspection method in Part II of Pharmacopoeia of People's Republic of China (Edition 2010). 6.8 Arsenic content test Take 1.0g of alginate dressing. Add 1.0g of calcium hydroxide. Mix. Add water to wet. First use a small fire to make the reaction complete. Then slowly bake at 500°C~600°C to complete carbonization. Let it cool. Add 5mL of hydrochloric acid and 23mL of water to make them dissolved. Perform according to Annex VIII J Arsenic salt inspection method "Method One" in Part II of Pharmacopoeia of People's Republic of China (Edition 2010). 6.9 Cadmium content test Take 1.0g of alginate dressing. Slowly bake at 500°C~600°C to complete carbonization. Let it cool. Add 5mL of hydrochloric acid and 23mL of water to make them dissolved. According to Annex IV D Atomic absorption spectrophotometry "Method One" in Part II of Pharmacopoeia of People's Republic of China (Edition 2010), determine at 228.5nm. 6.10 Calcium content test Take the sample under the weight loss test. Place in a crucible. Slowly cauterize for about 20 min. Let it cool. Add a little hydrogen peroxide (0.5 mL to 1.0 mL). Continue burning until there is no mass present. Fully gray at 700°C~800°C, completely turning from dark red to white. Let it cool. Add 10mL of hydrochloric acid (1+3), a few drops of concentrated nitric acid. Boil carefully. Transfer to a 100mL volumetric flask. Dilute with distilled water to the scale, shake. Use it as test solution. Accurately transfer 5mL of the above test solution into a 250mL Erlenmeyer flask. Add 50mL of distilled water, 5mL of sodium hydroxide solution, 1mL of 10% triethanolamine solution, 0.1g of calcium erythromycin indicator. Titrate with EDTA standard solution (c=0.01 mol/L), when it turns from burgundy to bright blue, it shall be the end. Calculate the calcium content according to equation (1). where, c - EDTA titrant concentration in moles per liter (mol/L); Calcium content ......Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al. 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