YY/T 1556-2017: Translated English of Chinese Standard. (YYT 1556-2017, YY/T1556-2017, YYT1556-2017): Test methods for particle contamination of infusion, transfusion and injection equipment for medical use
https://www.chinesestandard.net, 7 apr 2019 - 12 pagine
This Standard specifies test methods for particle contamination of intravenous infusion, blood transfusion, injection equipment. This Standard is applicable to particle contamination inspection of intravenous infusion device. For other products, the particle contamination test method can refer to this Standard. This Standard is not applicable to syringe for intramuscular injection with a nominal capacity of 1 mL or less.
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100mL of collected 100mL of fluids 20s to obtain blank test blood transfusion catheter hub Classify and count collected fluid Combine the obtained contamination of infusion counting method direct or indirect easy to foam elute 2min Erlenmeyer flask 7.3 evaluation coefficient extract the fluids fluid or collected fluids after washing fluids for washing flush the lumen GB/T human blood indirect contact Infusion Device inner surface intravenous infusion Isopropanol is highly least 100mL lumen according microscope nominal capacity greater number of particles obtain 3 portions oscillate for 20s oscillating device 7.5 particle contamination index particle counter 7.6 particle counter method particles in blank particles in fluids Piercing devices piston pollution index prescribed method NOTE Purified water 7.1.1 Respectively extract Shandong Standard Take 10 test test methods test piece test samples test syringes times/min transfusion and injection Tween-80 solution ultrasonic cleaner unit washing fluid washing is less washing of nominal washing to obtain