YBB 00062004-2015 English PDF (YBB00062004-2015)

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YBB 00062004-2015: Borosilicate glass barrels for prefilled syringes
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