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
中文标准名称：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
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 (ISO 11140-4:2007);German version EN ISO 11140-4:2007
标准类型：C47
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：C47
引用标准：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
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.