YY 0497-2005 Translated English of Chinese Standard. YY0497-2005: Sterile insulin syringe for single usehttps://www.chinesestandard.net, 19 Jul 2015 - 32 halaman This Standard specifies classification, requirements, test methods, inspection rules, marks, operation instructions, packaging, transportation, storage, etc. for insulin syringe for single-use. It covers syringes for use with 40 units of insulin/ml (U-40) and 100 units of insulin/ml (U-100). |
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accordance with Table Acute systemic toxicity Annex G Apply to Inspection Batch number starts blank contrast solution Bonding strength Capacity tolerance Chinese character conform core pin curl of coat Description of interiors dimension Edge curl endotoxin Equipment for Medical ethylene oxide fitted with protective Fitting of plunger Graduated capacity line head of syringe Hemolysis including nominal capacity injection needle insulin syringe License number Lot-by-lot inspection Luer male conical fitting Manufacturer’s name medical devices Medium packages method specified milliliters month of expiry needle for syringes needle tubing Nominal outer diameter non-conformance classification non-pyrogen number as required Packaged syringes Periodic inspection plunger and coat pressing-hand Procedures and Tables production protective end caps provisions of Table re-use sampling plan self-sealing syringe units single package stylet surface of syringe syringe and needle syringe coat syringe for single-use Syringes of type test methods Test solution prepared test TEST according total graduated capacity unit container YY/T