Powered by Google www.ChineseStandard.net Database: 189760 (25 May 2024)

YBB 00062004-2015 related PDF English

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



Preview PDF: YBB 00062004-2015

YBB 00062004-2015: PDF in English
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
......

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