YY/T 1555.2-2018 PDF EnglishUS$150.00 · In stock · Download in 9 seconds
YY/T 1555.2-2018: Particular requirements for the silicone gel filled breast implant - Performance requirement of silicone gel filler - Part 2: Limits requirement for extractable substances Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedure Status: Valid
Similar standardsYY/T 1555.2-2018: Particular requirements for the silicone gel filled breast implant - Performance requirement of silicone gel filler - Part 2: Limits requirement for extractable substances---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/YYT1555.2-2018 YY PHARMACEUTICAL INDUSTRY STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA ICS 11.040.30 C 30 Particular requirements for the silicone gel filled breast implant - Performance requirement of silicone gel filler - Part 2: Limits requirement for extractable substances ISSUED ON: DECEMBER 20, 2018 IMPLEMENTED ON: JANUARY 01, 2020 Issued by: National Medical Products Administration Table of ContentsForeword ... 3 1 Scope ... 4 2 Normative references ... 4 3 Terms and definitions ... 4 4 Limit requirements ... 5 5 Detection methods ... 6 Appendix A (Normative) Preparation method of extract ... 7 Appendix B (Normative) Determination of residual amount of oligosiloxane substances: gas chromatography (GC method) ... 8 Bibliography ... 11 Particular requirements for the silicone gel filled breast implant - Performance requirement of silicone gel filler - Part 2: Limits requirement for extractable substances1 ScopeThis Part of YY/T 1555 specifies the extraction methods, detection methods and limit requirements for extractable substances in the silicone gel filler used for artificial mammary implant. This Part applies to artificial mammary implants with silicone gel as the inner filler.2 Normative referencesThe following documents are indispensable for the application of this document. For dated references, only the dated version applies to this document. For undated references, the latest edition (including all amendments) applies to this Standard. YY 0334-2002, General specification for surgical implants made of silicone elastomer YY/T 1457, Non-active surgical implants - Determination method for oligomeric siloxanes in mammary implants3 Terms and definitionsThe following terms and definitions apply to this document. 3.1 mammary implant An implant with a shell, which is used for increasing the volume of the breast or replacing the breast. The shell can be filled with objects by a manufacturer or a surgeon. [YY 0647-2008, definition 3.5] 3.2 filler The contents of the implant.Appendix B(Normative) Determination of residual amount of oligosiloxane substances: gas chromatography (GC method) B.1 Principle Use gas chromatography to analyze the small molecules in the extract. When the vaporized sample is carried by the mobile phase into the chromatographic column for operation, it is repeatedly distributed between the two phases. Due to the different distribution coefficients of each component between the mobile phase and the stationary phase, the running speed of each component in the chromatographic column is different. After a certain column length, they are separated from each other. They leave the chromatographic column and enters the detector in sequence. The detector can convert the sample component information into an electrical signal; the size of the electrical signal is proportional to the amount or concentration of the measured component, so as to realize the detection of the measured component. B.2 Apparatus B.2.1 Gas chromatograph, with hydrogen flame ionization detector. B.2.2 Electronic balance (precision of 0.1 mg). B.2.3 Ultrasonic cleaner. B.3 Reagents B.3.1 Acetone, required to be analytical grade and above. B.3.2 Octamethylcyclotetrasiloxane (D4), required to be analytical grade and above. B.3.3 Decamethylcyclopentasiloxane (D5), required to be analytical grade and above. B.4 Test methods B.4.1 Standard solution preparation Take about 0.05 g of D4, D5 and other oligosiloxane substances respectively; accurately weigh them; use acetone to dilute the solution to 50 mL; then, use acetone to dilute the solutions successively, to prepare mixed standard solutions of D4 and D5 oligosiloxane substances of at least 5 concentration gradients from 1 μg/mL to 50 μg/mL. B.4.2 Gas phase determination Chromatographic conditions: Chromatographic column: capillary column (30 m × 0.25 mm × 0.25 μm) with 5% phenyl-95% polydimethylsiloxane as the fixed liquid; Column temperature: 60 °C (hold for 3 min), raise to 300 °C at 10 °C/min (hold for 10 min); Inlet temperature: 280 °C; Detector temperature: 300 °C; Carrier gas: helium or nitrogen (purity above 99.99%), flow rate of 1.0 mL/min; Injection volume: 1 μL. Take the blank solution, standard solution, and sample solution (see A.3 for the preparation method) for the gas chromatograph test. Take a standard solution of an intermediate concentration and inject consecutively 5 times, to calculate the relative standard deviation (RSD) of the peak area of oligosiloxane substances. B.5 Result analysis B.5.1 Use the external standard method to analyze the test results; establish a standard working curve and a regression equation; calculate the residual amount of oligosiloxane substances in the sample according to Formula (B.1). The measurement results are expressed as the ratio of the mass (μg) of oligosiloxane substances to the mass (g) of the test mass; the unit is μg/g, namely, mg/kg. Where: X – the residual amount of oligosiloxane substances, in micrograms per gram (μg/g, namely, mg/kg); c – the concentration value of oligosiloxane substances in the sample test solution, which is read on the standard curve, in micrograms per milliliter (μg/mL); V – the volume of the added extraction solvent acetone, in milliliters (mL); m – the mass of the sample, in grams (g). B.5.2 If the concentration value read on the standard curve is less than the minimum concentration value of the standard solution, the result is expressed by Formula (B.2): ......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 1555.2-2018 be delivered?Answer: The full copy PDF of English version of YY/T 1555.2-2018 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 1555.2-2018_English with my colleagues?Answer: Yes. The purchased PDF of YY/T 1555.2-2018_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. 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