YY/T 0908-2013: Translated English of Chinese Standard. (YYT0908-2013): Single-use filter for syringe
https://www.chinesestandard.net, 2022 M03 6 - 15 páginas
This Standard specifies classification and marking, materials, physical requirements, chemical requirements, biological requirements, signs, packaging for single-use filter for syringe.
Comentarios de la gente - Escribir un comentario
No encontramos ningún comentario en los lugares habituales.
Classification and marking
Annex A Normative Physical test
Annex B Normative Type inspection rules
100mL of test accordance with YY/T according to Chapter according to GB/T applies base Biological blank bubble point pressure Chemical clean counter clearly marked contamination contents count range dialysis direct clinical drugs effect eluate ethylene oxide evaluation exceed filter for syringe filter is sterile Filter nominal pore filter removal rate Filter specification filtrate fittings Flow given in accordance given in YY/T graphic symbols given indicate initial packaging injection equipment integrity joint Label latex particles less than 15mL liquid mass concentration Medical Device meet the requirements name and specification needles nominal pore size non-sterile NOTE Number of particles Packaging materials particle size counting particles measured Physical requirements pieces point pressure tester product is provided protective cover Reagents references signs Single-use filter sodium chloride injection specification marking Standard Steps storage structure surface Table A.1 Take test cell Test methods test solution tested according total sampling volume Unsterilized