HOME   Cart(0)   Quotation   About-Us Tax PDFs Standard-List Powered by Google www.ChineseStandard.net Database: 189760 (7 Sep 2024)

YBB 00062004-2015 English PDF

YBB 00062004-2015_English: PDF (YBB00062004-2015)
Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusPDF
YBB 00062004-2015English110 Add to Cart 0--9 seconds. Auto-delivery Borosilicate glass barrels for prefilled syringes Valid YBB 00062004-2015
Standards related to: YBB 00062004-2015

BASIC DATA
Standard ID YBB 00062004-2015 (YBB00062004-2015)
Description (Translated English) Borosilicate glass barrels for prefilled syringes
Sector / Industry Medical & Pharmaceutical Packaging Industry Standard
Classification of Chinese Standard C08
Word Count Estimation 2,222
Date of Issue 2015-08-11
Date of Implementation 2015-12-01
Older Standard (superseded by this standard) YBB 0006-2004
Regulation (derived from) China Food & Drug Administration Announcement 2015 No.164

YBB 00062004-2015 NATIONAL STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA Borosilicate glass barrels for prefilled syringes Borosilicate glass barrels for prefilled syringes This standard applies to borosilicate glass barrels for prefilled syringes which contain injection solutions. There are two forms: with an injection needle or a Luer taper. [Appearance] Take an appropriate amount of this product. In a bright place with natural light, visually check it from front side. It shall be colorless and transparent; the surface shall be smooth and flat; there shall be no obvious glass defects; there shall be no cracks in any part. [Identification] * (1) Linear thermal expansion coefficient: Take appropriate amount of this product. Follow the “Determination method for average linear thermal expansion coefficient” (YB 00202003-2015) or “Determination method for linear thermal expansion coefficient” (YBB 00212003-2015) to make determination. The linear thermal expansion coefficient of medium borosilicate glass shall be (3.5 ~ 6.1) x 10-6 K-1 (20 ~ 300 °C); the linear thermal expansion coefficient of high borosilicate glass shall be (3.2 ~ 3.4) x 10-6 K-1 (20 ~ 300 °C). (2) Content of boron trioxide: Take appropriate amount of this product. Follow the “Determination method of boron trioxide” (YBB 00232003-2015) to make determination. The boron trioxide of medium boron silicon glass shall be not less than 8%; boron trioxide of high boron silicon glass shall be not less than 12%. [Particle water resistance at 121 °C] Take an appropriate amount of this product. Follow the “Determination method and classification of water resistance of glass particle at 121 °C” (YBB 00252003-2015) to make determination. It shall meet the level 1 requirements. [Inner surface water resistance] Take an appropriate amount of this product. Follow the “Determination method and classification of inner surface water resistance at 121 °C” (YBB 00242003-2015) to make determination, which shall meet the HC1 level requirements. [Internal stress] Take an appropriate amount of this product. Follow the “Determination method of internal stress” (YB 00162003-2015) to make determination. The optical path difference caused by the maximum permanent stress after annealing must not exceed 40 nm/mm. [Leaching amount of arsenic, antimony, lead, cadmium] * Take an appropriate amount of this product. Follow the “Determination method of leaching amount of arsenic, antimony, lead, cadmium” (YBB 00372004-2015) to make determination. In each liter of leaching liquid, the arsenic shall not exceed 0.2 mg, the antimony shall not exceed 0.7 mg, the lead shall not exceed ...