Sterilization of health care products — Chemical indicators — Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test
保健品灭菌——化学指示剂第3部分:用于Bowie和Dick型蒸汽渗透试验的2级指示剂系统
发布日期:
2007-03-15
ISO 11140-3:2007规定了包装物品(如仪器和多孔材料)蒸汽灭菌器蒸汽渗透试验中使用的化学指示剂的要求。用于此目的的指示器为ISO 11140-1中所述的2级指示器。
符合ISO 11140-3:2007的指示器拟与EN 285中所述的标准测试包结合使用。ISO11140—3:2007没有考虑标准测试包的性能,而是指定了指示器的性能。
ISO 11140-3:2007 specifies the requirements for chemical indicators to be used in the steam penetration test for steam sterilizers for wrapped goods, e.g. instruments and porous materials. The indicator for this purpose is a Class 2 indicator as described in ISO 11140-1.
Indicators complying with ISO 11140-3:2007 are intended for use in combination with the standard test pack as described in EN 285. ISO 11140-3:2007 does not consider the performance of the standard test pack, but does specify the performance of the indicators.