YY 0325-2016 Translated English of Chinese Standard. YY0325-2016: Sterile urethral catheter for single usehttps://www.chinesestandard.net, 24 giu 2018 - 26 pagine This Standard specifies the terms and definitions, requirements, symbols and markings, packaging, etc. for sterile urethral catheter for single use. This Standard applies to sterile urethral catheter with balloon and without balloon for single use. |
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14 days 150 Not applicable Ammonium chloride Anhydrous applicable With balloon balloon is filled Bending resistance test biocompatibility catheter for single catheter is immersed catheter’s drainage cavity catheters with balloon catheters without side chloride connecting device counterbore countersink device and weights device for weights Distilled water drain hole drainage conical interface ethylene oxide Figure E.1 filling conical interface flow following information g Sodium given in Annex immersed in simulated measuring cylinder Medical Devices method given minimum shaft length nominal balloon capacity nominal capacity packaging phosphate 2.5 PLACE the urethral reagents REMOVE the urethral report shall include report The test Shandong side holes Sodium chloride specified in Table Standard Sterile urethral catheter symbols and markings Table C.1 temperature at 37 test connector Test layout Test method Test report test urethral catheter tested in accordance total mass urethral catheter balloon urethral catheter identification urethral catheter’s drainage urine for 14 valve Water bath YY/T