YBB 00292005-2-2015 PDF in English
YBB 00292005-2-2015 (YBB00292005-2-2015) PDF English
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Name of Chinese Standard | Status |
| YBB 00292005-2-2015 | English | 70 |
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Injection Vials Made of Middle Borosilicate Glass Tubing
| Valid |
Standards related to (historical): YBB 00292005-2-2015
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YBB 00292005-2-2015: PDF in English YBB00292005-2-2015
YBB
Injection Vials Made of Middle Borosilicate Glass Tubing
中硼硅玻璃管制注射剂瓶
The Standard is applicable to injection vials made of middle borosilicate glass
tubing containing directly-dispensed injections, sterile powders for injection and
concentrated solutions for injection.
[Appearance] TAKE appropriate amount of this product; in the light of natural
light, visually INSPECT from front. It shall be colorless and transparent or brown
and transparent; the surface shall be clean and smooth, and there shall be no
obvious glass defects; no cracks are allowed on any part.
[Identification]* (1) Coefficient of linear thermal expansion. TAKE
appropriate amount of this product, DETERMINE according to Tests for
Coefficient of Mean Linear Thermal Expansion (YBB00202003-2015) or Tests
for Coefficient of Linear Thermal Expansion (YBB00212003-2015). It shall be
(3.5 ~ 6.1) × 10-6 K-1 (20 ~ 300 °C).
(2) Content of boron oxide. TAKE appropriate amount of this product,
DETERMINE according to Determination of Boron Oxide (YBB00232003-2015).
The content of boron oxide shall not be less than 8 %.
[Hydrolytic resistance of glass grains at 121 °C] TAKE appropriate amount
of this product, DETERMINE according to Test and Classification for Hydrolytic
Resistance of Glass Grains at 121 °C (YBB00252003-2015). It shall comply
with Grade 1.
[Hydrolytic resistance of glass grains at 98 °C] TAKE appropriate amount of
this product, DETERMINE according to Test and Classification for Hydrolytic
Resistance of Glass Grains at 98 °C (YBB00362004-2015). It shall comply with
Grade HGB1.
[Hydrolytic resistance of interior surfaces] TAKE appropriate amount of this
product, DETERMINE according to Test and Classification for Hydrolytic
Resistance of Interior Surfaces at 121°C (YBB00242003-2015). It shall comply
with Grade HC1.
[Acid resistance]* TAKE appropriate amount of this product, DETERMINE
according to the first method of Tests for Resistance to Attack of Glass by
Boiling Hydrochloric Acid (YBB00342004-2015), it shall comply with Grade 1;
or DETERMINE according to the second method of Tests for Resistance to
Attack of Glass by Boiling Hydrochloric Acid (YBB00342004-2015), the amount
of alkaline oxide leaching shall not exceed 100 μg/dm2.
[Alkali resistance]* TAKE appropriate amount of this product, DETERMINE
according to Tests for Resistance to Attack of Glass by Mixed Alkali Aqueous
Solution (YBB00352004-2015), it shall not be lower than Grade 2.
[Internal stress] TAKE appropriate amount of this product, DETERMINE
according to Test for Stress (YBB00162003-2015). The optical path difference
caused by the maximum permanent stress after annealing shall not exceed 40
nm/mm.
[Heat resistance] TAKE appropriate amount of this product, PLACE it in an
oven, HEAT to 180 °C in 30 minutes and KEEP at constant temperature for 2
hours, REMOVE it immediately, it shall not be broken.
[Freezing resistance] TAKE appropriate amount of this product, INJECT 1/2
of the nominal capacity of water into the freezer. The temperature is controlled
at -41 °C ± 2 °C. REMOVE after 24 hours, immediately PLACE it in the water
at 40 °C ± 1 °C; REMOVE after 1 minute, it shall not be broken.
[Leaching amount of arsenic, antimony, lead, cadmium]* TAKE appropriate
amount of this product, DETERMINE according to Tests for Leaching Amount
of Arsenic, Antimony, Lead and Cadmium (YBB00372004-2015). In per liter of
leachate, arsenic shall not exceed 0.2 mg, antimony shall not exceed 0.7 mg,
lead shall not exceed 1.0 mg, and cadmium shall not exceed 0.25 mg.
[Vertical axis deviation] TAKE appropriate amount of this product,
DETERMINE according to Test for Vertical Axis Deviation of Bottles
(YBB00192003-2015). It shall comply with the specifications of Table 1.
......
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.
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