YY/T 0908-2013 Translated English of Chinese Standard. (YYT0908-2013): Single-use filter for syringeThis Standard specifies classification and marking, materials, physical requirements, chemical requirements, biological requirements, signs, packaging for single-use filter for syringe. |
Contents
| 3 | |
Scope | 4 |
Classification and marking | 5 |
Materials | 6 |
Chemical requirements | 7 |
Biological requirements | 8 |
Signs | 9 |
Packaging | 10 |
Annex A Normative Physical test | 11 |
Annex B Normative Type inspection rules | 15 |
Common terms and phrases
100mL of test accordance with YY/T according to Chapter according to GB/T bubble point pressure clean counter concentration of 9g/L count range Count the latex direct clinical eluate eluent ethylene oxide exceed filter for syringe filter is sterile Filter nominal pore filter removal rate Filter specification filtrate given in accordance given in YY/T graphic symbols given including resistance method initial packaging injection equipment Instruments Particle counter latex particles less than 15mL liquid mass concentration Medical Device meet the requirements method in GB/T method or photoresist milliliter pieces/mL nominal pore size non-sterile Number of particles Packaging materials particle size counting photoresist method pieces per milliliter point pressure tester Pressure gauge pretreated filter product is provided protective cover sample pool according Single-use filter size count range sodium chloride injection specification marking Standard Table A.1 taper for syringes Test cell base Test methods test solution A.1.2 tested according total sampling volume Unsterilized