Standard No.:	YBB00112004-2015
Chinese Name:	预灌封注射器组合件(带注射针)
English Name:
Professional Classification:	YB Professional Standard - Metallurgy
Issued by:
Issued on:	2015-08-11
Implemented on:	2015-12-01
Status:	VALID
Replace:	YBB00112004
Language:	English
File Format:	PDF
Word Count:
Price(USD):	please email coc@codeofchina.com for quotation
Delivery:	via email in

This standard is applicable to the assemblages for prefilled syringes (with stainless steel needles). The assemblages are composed of glass needle tubing, rubber plunger, stainless steel needle, needle cap and push rod.

[Appearance] Take appropriate amount of this product, and carry out visual inspection in the bright place of natural light. The sleeve of glass needle tubing shall be free of cracks or seams, and the curling edge shall be free of deformation; the conical head and curling edge shall be free of cracks or breakage; the outer surface of the needle tubing shall be free of spots, stains and scratches; there is no printing defects affecting the use; the needle shall be free of separation, up-down reversal, or blocking; and the needle and needle cap shall not be separated.

[Glass needle tubing] It shall meet the requirements of YBB00062004-2015 Borosilicate Glass Needle Tubing for Prefilled Syringes.

[Rubber plunger] It shall meet the requirements of YBB00072004-2015 Chlorobutyl Rubber Plungers for Prefilled Syringes or YBB00082004-2015 Bromobutyl Rubber Plungers for Prefilled Syringes.

[Stainless steel needle] It shall meet the requirements of YBB00092004-2015 Stainless Steel Needles for Prefilled Syringes.

[Needle cap] It shall meet the requirements of YBB00102004-2015 Polyisoprene Rubber Caps for Prefilled Syringe Needles.