YY/T 1555.2-2018 Translated English of Chinese Standard. (YYT1555.2-2018): Particular requirements for the silicone gel filled breast implant. Performance requirement of silicone gel filler - Part 2: Limits requirement for extractable substances
https://www.chinesestandard.net, 2022 M01 6 - 11 pages
This 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.
according to A.1 acetone to dilute added extraction solvent amount of oligosiloxane amount of silicone analytical grade analyze appropriate amount area of oligosiloxane artificial mammary implant balance to weigh blank control solution chromatographic column D4 and D5 Decamethylcyclopentasiloxane D5 detector dichloromethane extract document Evaporation residue exceed 50 mg/kg extract according extract Take extractable substances extraction solvent acetone filled breast implant g of sample Gas chromatograph gel filled breast grams g Heavy metals Limits requirement method in Appendix micrograms per gram micrograms per milliliter milliliters mL minimum concentration value Octamethylcyclotetrasiloxane D4 oligosiloxane substances perform the test Preparation method prepare the blank Prepare the extract purified water readily oxidizable substances Reducing substances readily relative standard deviation requirement for extractable requirement of silicone residual amount sample to 20 sample water extract Shenzhen silicone gel filler standard curve standard deviation RSD standard solution substances readily oxidizable surgical implants temperature test according Wang YY/T