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Standard ID	Contents [version]	USD	STEP2	[PDF] delivered in	Standard Title (Description)	Status	Related Standard
YBB 00112004-2015	English	110	Add to Cart	0--10 minutes. Auto immediate delivery.	Assemblages for prefilled syringes (with stainless-steel needles)	Valid	YBB 00112004-2015
YBB 00112004-2015	Chinese	RFQ	ASK	<=1-day	[PDF from Chinese Authority, or Standard Committee, or Publishing House]

Detail Information of YBB 00112004-2015; YBB00112004-2015
Description (Translated English): (Prefilled syringe assembly (with the needle))
Sector / Industry: Medical & Pharmaceutical Packaging Industry Standard
Classification of Chinese Standard: C08
Word Count Estimation: 3,380
Date of Issue: 2015-08-11
Date of Implementation: 2015-12-01
Older Standard (superseded by this standard): YBB 0011-2004
Regulation (derived from): China Food & Drug Administration Announcement 2015 No.164

YBB00112004-2015
YY / YBB
National Drug Packing Container (Material) Standard
Assemblages for prefilled syringes
(with stainless-steel needles)
预封装注射器组合件(带注射针)
ISSUED ON. AUGUST 11, 2015
IMPLEMENTED ON. DECEMBER 01, 2015
Issued by. China Food and Drug Administration of PRC
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Assemblages for prefilled syringes
(with stainless-steel needles)
This standard applies to prefilled syringe assemblages (with stainless-steel needles). The
assemblage consists of a glass needle, a rubber piston, a stainless-steel needle, a needle
cap, and a putter.
[Appearance] TAKE appropriate amount of this product; MAKE direct visual inspection
against the product in a bright place in natural light. The glass needle tube sleeve shall be
free from cracks or fractures AND the curling shall be free from deformation; the cone and
curling shall be free from cracks or breakage; the needle tube external surface shall be free
from spots, stains, or scratches; there shall be no printing defects which may affect normal
use; the needle shall be free from separation, reversing, or obstruction; AND the needle and
needle cap shall be free from separation.
[Glass needle tube] It shall meet the requirements for the borosilicate glass needle tube
which is used for the prefilled syringe (YBB00062004-2015).
[Rubber piston] It shall meet the requirements for the chlorinated butyl rubber piston
(YBB00072004-2015) or the brominated butyl rubber piston (YBB00082004-2015) which is
used for the prefilled syringe.
[Stainless-steel injection needle] It shall meet the requirements for the stainless-steel
injection needle (YBB00092004-2015) which is used for the prefilled syringe.
[Needle cap] It shall meet the requirements of the polyisoprene rubber needle cap which is
used for the prefilled syringe (YBB00102004-2015).
[Connection force between needle and needle seat] TAKE appropriate amount of this
product; FIX the syringe onto the test machine; at the rate of 100 mm/min ± 5 mm/min AND
the tensile force not less than 22 N, PERFORM the syringe pull test. There shall be no
loosening or separation between the stainless-steel needle and the needle seat of the glass
needle tube.
[Needle cap pull out force] TAKE appropriate amount of this product; FIX the needle cap
and the syringe tube onto the upper and lower fixtures of the test machine; the test rate is
100 mm/min ± 5 mm/min. The pull-out force of the needle cap shall be 4.0 ~ 45.0 N.
[Fit between piston and putter] (only for threaded pistons) TAKE appropriate amount of
this product; CONNECT the putter and the piston; INSERT the piston totally into the prefilled
syringe which had been lubricated by the silicon oil and filled with half water; EMPTY the air;
CAP the syringe needle; slowly WITHDRAW about 3 mm backwards. The putter shall be
kept stable AND not be separated from the piston.
[Piston lubrication] Take appropriate amount of this product; INSERT the piston into the
syringe tube which had been lubricated by silicone oil; USE the putter to push the p......

Related standard:   YBB 00112002-2015  YBB 00112003-2015