標準號：BS EN ISO 11140-4-2007
中文標準名稱：保健品滅菌.化學指示劑.蒸汽滲透檢測布維-狄(Bowie和Dick)型試驗可選2級指示劑
英文標準名稱：Sterilization of health care products - Chemical indicators - Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration
標準類型：C47
發布日期：2007/3/30 12:00:00
實施日期：2007/3/30 12:00:00
中國標準分類號：C47
國際標準分類號：11.080.20
適用范圍：ISO 11140-4:2007 specifies the performance for a Class 2 indicator to be used as an alternative to the Bowie and Dick-type test for steam sterilizers for wrapped health care goods (instruments, etc. and porous loads).An indicator complying with ISO 11140-4:2007 incorporates a specified material which is used as a test load. This test load may, or may not, be re-usable. ISO 11140-4:2007 does not specify requirements for the test load, but specifies the performance of the indicator in combination with the test load with which it is intended to be used. The indicator specified in ISO 11140-4:2007 is intended to identify poor steam penetration but does not necessarily indicate the cause of this poor steam penetration.This part of ISO 11140-4:2007 does not include test methods to establish the suitability of these indicators for use in sterilizers in which the air removal stage does not include evacuation below atmospheric pressure.