DIN EN ISO 11140-4:2007 PDF

Scope: 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 Referenced Document

EN 285:2006 Sterilization - Steam sterilizers - Large sterilizers (Incorporates Amendment A2: 2009)
IEC 60584-2:1982 Thermocouples Part 2: Tolerances (Edition 1.0)
IEC 60751:1983 Industrial platinium resistance thermometer sensors
ISO 10012-1 Quality assurance requirements for measuring equipment; part 1: metrological confirmation system for measuring equipment
ISO 11140-1:2005 Sterilization of health care products - Chemical indicators - Part 1: General requirements
ISO 187:1990 Paper, board and pulps; standard atmosphere for conditioning and testing and procedure for monitoring the atmosphere and conditioning of samples
ISO 2248 Packaging; Complete, filled transport packages; Vertical impact test by dropping
ISO 5-1 Photography and graphic technology - Density measurements - Part 1: Geometry and functional notation*， 2009-12-01 Update
ISO 5-3 Photography and graphic technology - Density measurements - Part 3: Spectral conditions*， 2009-12-01 Update
ISO 5-4:1995 Photography - Density measurements - Part 4: Geometric conditions for reflection density
ISO/CIE 10526:1999 CIE standard illuminants for colorimetry

2007 DIN EN ISO 11140-4:2007-07 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
2007 DIN EN ISO 11140-4:2007 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
0000 DIN EN ISO 11140-4:2005
0000 DIN EN 867-4:2001