DIN EN ISO 11140-4:2007
卫生保健产品的灭菌.化学指示剂.第4部分:蒸汽渗透检测用可代替真空灭菌锅残余空气试验的指示剂

标准号: DIN EN ISO 11140-4:2007
发布: 2007年
发布单位: 德国标准化学会
替代标准: DIN EN ISO 11140-4:2007-07
当前最新: DIN EN ISO 11140-4:2007-07

引用标准: EN 285:2006 IEC 60584-2/A1:1989 IEC 60584-2:1982 IEC 60751-A1:1986 IEC 60751:1983 ISO 10012-1 ISO 11140-1:2005 ISO 187:1990 ISO 2248 ISO 5-1 ISO 5-3 ISO 5-4:1995 ISO/CIE 10526:1999
被代替标准: DIN EN 867-4:2001 DIN EN ISO 11140-4:2005

适用范围: 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.

DIN EN ISO 11140-4:2007卫生保健产品的灭菌.化学指示剂.第4部分:蒸汽渗透检测用可代替真空灭菌锅残余空气试验的指示剂