標準號：DIN EN ISO 11140-4-2007
中文標準名稱：衛生保健產品的滅菌.化學指示劑.第4部分:蒸汽滲透檢測用可代替真空滅菌鍋殘余空氣試驗的指示劑
英文標準名稱：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 (ISO 11140-4:2007);German version EN ISO 11140-4:2007
標準類型：C47
發布日期：1999/12/31 12:00:00
實施日期：1999/12/31 12:00:00
中國標準分類號：C47
引用標準：ISO 5-4-1995;ISO 5-1;ISO 5-3;ISO 187-1990;ISO 2248;ISO 10012-1;ISO 11140-1-2005;ISO/CIE 10526-1999;EN 285-2006;IEC 60584-2-1982;IEC 60584-2/A1-1989;IEC 60751-1983;IEC 60751-A1-1986
適用范圍：This part ISO 11140 specifies the performance for a Class 2 indicator to be used as an alternative to the Bowie an Dick-type test for steam sterilizers for wrapped health care goods(instruments,etc,.and porous loads).NOTE The Bowie and Dick-type test is used for routine testing of steam sterilizers and validation of steam sterilization processes. An indicator complying with this part of ISO 11140 incorpotates a specified material which is used as a test load.This test load may,or may not,be re-usable. This part of ISO 11140 does not specify requirements for the test load,but specified the performance of the indicator in combination with the test load with which it is intended to be used.The indicator specified in this part of ISO 11140 is intended to identify poor steam penetration 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 for use in sterilizers in which the air removal stage does not include evacuation below atmospheric pressure.