ISO 11140-4-2007 卫生保健品的灭菌.化学指示剂.第4部分:蒸汽穿透检测布维-狄(Bowie and Dick)形式试验的2级指示剂

标准号：ISO 11140-4-2007
中文标准名称：卫生保健品的灭菌.化学指示剂.第4部分:蒸汽穿透检测布维-狄(Bowie and Dick)形式试验的2级指示剂
英文标准名称：Sterilization of health care products - Chemical indicators - Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration
标准类型：C50
发布日期：1999/12/31 12:00:00
实施日期：1999/12/31 12:00:00
中国标准分类号：C50
国际标准分类号：11.080.01;11.080.20
适用范围：This part of ISO 11140 specifies the performance for a Class 2 indicator to be used as an alternative to theBowie and Dick-type test for steam sterilizers for wrapped health care goods (instruments, etc., and porousloads).NOTE The Bowie and Dick-type test is used for routine testing of steam sterilizers and validation of steamsterilization processes.An indicator complying with this part of ISO 11140 incorporates a specified material which is used as a testload. This test load may, or may not, be re-usable. This part of ISO 11140 does not specify requirements forthe test load, but specifies the performance of the indicator in combination with the test load with which it isintended to be used. The indicator specified in this part of ISO 11140 is intended to identify poor steampenetration but does not necessarily indicate the cause of this poor steam penetration.This part of ISO 11140 does not include test methods to establish the suitability of these indicator systems foruse in sterilizers in which the air removal stage does not include evacuation below atmospheric pressure.