ISO 13408-5:2006 - $103.00   BUY NOW

Aseptic processing of health care products - Part 5: Sterilization in place

ISO 13408-5:2006 Publication Description:

ISO 13408-5:2006 specifies the general requirements for sterilization in place (SIP) applied to product contact surfaces of the equipment used in the manufacture of sterile health care products by aseptic processing and offers guidance on qualification, validation, operation and control.

ISO 13408-5:2006 applies to processes where sterilizing agents are delivered to the internal surfaces of equipment that can come in contact with the product.

International Classification for Standards (ICS)

ICS Classification Field ICS Field Sub-Group and Number
ICS-11-Health ICS Sterilization-General (11.080.01)

ICS Related Standards

Cart Document Number Document Title
$209.00 ISO 11135:2014 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
$189.00 ISO 11135-1:2007 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
$180.00 ISO/TS 11135-2:2008 Sterilization of health care products - Ethylene oxide - Part 2: Guidance on the application of ISO 11135-1
$185.00 ISO 11137-1:2006 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
$19.00 ISO 11137-1:2006/Amd1:2013 - Amendment 1
$209.00 ISO 11137-2:2013 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
$103.00 ISO 11137-3:2006 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects
$185.00 ISO 11138-1:2006 Sterilization of health care products - Biological indicators - Part 1: General requirements
$45.00 ISO 11138-2:2006 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes
$68.00 ISO 11138-3:2006 Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes
$68.00 ISO 11138-4:2006 Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes
$68.00 ISO 11138-5:2006 Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
$103.00 ISO/TS 11139:2006 Sterilization of health care products - Vocabulary
$162.00 ISO 11140-1:2014 Sterilization of health care products - Chemical indicators - Part 1: General requirements
$156.00 ISO 11140-1:2005 Sterilization of health care products - Chemical indicators - Part 1: General requirements
$138.00 ISO 11140-3:2007 Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test
$162.00 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
$68.00 ISO 11140-5:2007 Sterilization of health care products - Chemical indicators - Part 5: Class 2 indicators for Bowie and Dick-type air removal tests
$185.00 ISO 11737-1:2006 Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products
$103.00 ISO 11737-2:2009 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
$209.00 ISO/TS 13004:2013 Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD
$185.00 ISO 13408-1:2008 Aseptic processing of health care products - Part 1: General requirements
$19.00 ISO 13408-1:2008/Amd1:2013 - Amendment 1
$68.00 ISO 13408-2:2003 Aseptic processing of health care products - Part 2: Filtration
$68.00 ISO 13408-3:2006 Aseptic processing of health care products - Part 3: Lyophilization
$103.00 ISO 13408-4:2005 Aseptic processing of health care products - Part 4: Clean-in-place technologies
$103.00 ISO 13408-6:2005 Aseptic processing of health care products - Part 6: Isolator systems
$19.00 ISO 13408-6:2005/Amd1:2013 - Amendment 1
$138.00 ISO 13408-7:2012 Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products
$162.00 ISO 14160:2011 Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices
$209.00 ISO 14161:2009 Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results
$185.00 ISO 14937:2009 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
$162.00 ISO 15882:2008 Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results
$103.00 ISO 17664:2004 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices
$185.00 ISO 17665-1:2006 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
$185.00 ISO/TS 17665-2:2009 Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1
$209.00 ISO/TS 17665-3:2013 Sterilization of health care products - Moist heat - Part 3: Guidance on the designation of a medical device to a product family and processing category for steam sterilization
$162.00 ISO 18362:2016 Manufacture of cell-based health care products - Control of microbial risks during processing
$162.00 ISO 18472:2006 Sterilization of health care products - Biological and chemical indicators - Test equipment
$209.00 ISO 20857:2010 Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices
$185.00 ISO 25424:2009 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices
$185.00 ISO 11137-3:2017 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control
$185.00 ISO 11138-1:2017 Sterilization of health care products - Biological indicators - Part 1: General requirements
$45.00 ISO 11138-2:2017 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes
$68.00 ISO 11138-3:2017 Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes
$68.00 ISO 11138-4:2017 Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes
$68.00 ISO 11138-5:2017 Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes