RO
SR EN ISO 11140-3:2009
Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test (ISO 11140-3:2007, including Cor 1:2007)
ISO 11140-3:2007 specifies the requirements for chemical indicators to be used in the steam penetration test for steam sterilizers for wrapped goods, e.g. instruments and porous materials. The indicator for this purpose is a Class 2 indicator as described in ISO 11140-1. Indicators complying with ISO 11140-3:2007 are intended for use in combination with the standard test pack as described in EN 285. ISO 11140-3:2007 does not consider the performance of the standard test pack, but does specify the performance of the indicators.
Status :
Valid
Approval date : 10/30/2009
Publish date : 11/1/2009
Number of pages : 28
ICS : 11.080.01 Sterilization and desinfectation
Technical Committee : 377 - Medical devices
- Replaces SR EN ISO 11140-3:2007
- Replaces SR EN ISO 11140-3:2007/AC:2009
- Normative reference SR EN ISO 11140-1:2006
- Normative reference SR ISO 5636-3:2001
- Normative reference SR EN ISO 5457:2002
- Normative reference SR EN 285+A2:2009