YY 0321.3-2009 Translated English of Chinese Standard. YY0321.3-2009: Single-use filter for anaesthesiaThis Standard specifies the requirements for single-use filter for anaesthesia. This Part is applicable to single-use filter for anaesthesia that is used together with single-use puncture needle for anesthesia. |
Contents
| 3 | |
Scope | 5 |
Classification and marks | 6 |
Materials | 7 |
Chemical requirements | 8 |
Biological requirements | 9 |
Annex A Normative Physical test | 11 |
Annex B Normative Type inspection rules | 14 |
Common terms and phrases
according to GB/T Adhesion test air filter Annex beginning with batch Biological evaluation clean counter sample comply cone joint protective Count the number counter sample pool distilled water Dust particle counter eluent Ethylene oxide Expression of results filter for anaesthesia filter Inject filter is aseptic filter is tested filter typical structure Filtration rate test five consecutive data flowmeter given in YY graphic symbols given including resistance method inner cone joint latex particles less than 15 liquid filter liquid leakage phenomenon measure the number Medical devices medical equipment milliliter pc/mL needle nominal pore number of particles outer 6:100 taper outer cone joint particle size range particles 0.5 µm Particulate contamination photoresist method piece per milliliter product model production lot number provides the filtration provisions of GB/T rate of liquid Read five consecutive Single-use filter Single-use puncture Standard sterilization Table A.1 taper for syringes test solution A.1.2 tested according total sample volume