S T E R I L I Z A T I O N - ISO standards

For questions and comments contact:

Radoslaw Wach - the Technical University of Lodz, POLAND; http://mitr.p.lodz.pl/biomat/ e-mail:

wach@mitr.p.lodz.pl

Standard Number Title

Sterilization of health care products - Ethylene oxide - Part 1:

ISO 11135-1:2007 Requirements for development, validation and routine control of a
sterilization process for medical devices.
ISO 11135-2:2008 & Sterilization of health care products - Ethylene oxide - Part 2: Guidance
ISO/TS 11135 -2: 2008 on the application of ISO 11135-1.
/Cor 1:2009
Sterilization of health care products -- Radiation - Part 1: Requirements for
ISO 11137-1:2006 development, validation and routine control of a sterilization process for
medical devices.
ISO 11137-2:2006 & Sterilization of health care products -- Radiation - Part 2: Establishing the
ISO 11137-2:2006 /Cor sterilization dose.
1:2009

ISO 11137-3:2006 Sterilization of health care products -- Radiation - Part 3: Guidance on

dosimetric aspects.
ISO 11138-1:2006 Sterilisation of healthcare products - Biological indicators - Part 1: General
requirements.

ISO 11138-2:2006 Sterilisation of healthcare products - Biological indicators - Part 2: Biological

indicators for ethylene oxide sterilisation processes.

ISO 11138-3:2006 Sterilisation of healthcare products - Biological indicators - Part 3:

Biological indicators for moist heat sterilisation processes.
ISO 11138-4:2006 Sterilization of health care products - Biological indicators - Part 4:
Biological indicators for dry heat sterilization processes.
ISO 11138-5:2006 Sterilization of health care products - Biological indicators - Part 5:
Biological indicators for low-temperature steam and formaldehyde
ISO/TS 11139:2006 Sterilisation of healthcare products - Vocabulary.
ISO 11140-1:2005 Sterilisation of healthcare products - Chemical indicators - Part 1: General
requirements.
ISO 11140-3:2007 & Sterilization of health care products - Chemical indicators - Part 3: Class
ISO 11140-3:2007/Cor 2 indicator systems for use in the Bowie and Dick-type steam
1:2007 penetration test.
 Sterilization of health care products - Chemical indicators - Part 4: Class
ISO 11140-4:2007 2 indicators as an alternative to the Bowie and Dick-type test for
detection of steam penetration.
Sterilization of health care products - Chemical indicators - Part 5: Class
ISO 11140-5:2007
2 indicators for Bowie and Dick-type air removal tests.

ISO 11607-1:2006 Packaging for terminally sterilized medical devices - Part 1:

Requirements for materials, sterile barrier systems and packaging
ISO 11607-2:2006 Packaging for terminally sterilized medical devices - Part 2: Validation
requirements for forming, sealing and assembly processes.
ISO 11737-1:2006 &
Sterilisation of medical devices — Microbiological methods — Part 1:
ISO 11737-1:2006/Cor
Estimation of population of microorganisms on products.
1:2007

Sterilization of medical devices - Microbiological methods - Part 2: Tests

ISO 11737-2:2009 of sterility performed in the definition, validation and maintenance of a
sterilization process.
ISO 13408-1:2008 Aseptic processing of health care products - Part 1: General requirements.

ISO 13408-2:2003 Aseptic processing of health care products - Part 2: Filtration.

ISO 13408-3:2006 Aseptic processing of health care products - Part 3: Lyophilization.

ISO 13408-4:2005 Aseptic processing of health care products - Part 4: Clean-in-place

technologies.
ISO 13408-5:2006 Aseptic processing of health care products - Part 5: Sterilization in place.

ISO 13408-6:2005 Aseptic processing of health care products - Part 6: Isolator systems.

Sterilisation of single-use medical devices incorporating materials of

ISO 14160:1998 animal origin - Validation and routine control of sterilisation by liquid
chemical sterilants.
ISO 14161:2009 Sterilisation of healthcare products - Biological indicators - Guidance for the
selection, use and interpretation of results.
Sterilisation of healthcare products - General requirements for
ISO 14937:2009 characterisation of a sterilising agent and the development, validation
and routine control of a sterilisation process for medical devices.
ISO 15882:2008 Sterilization of health care products - Chemical indicators - Guidance for
selection, use and interpretation of results.
Sterilization of health care products - Moist heat - Part 1: Requirements
ISO 17665-1:2006 for the development, validation and routine control of a sterilization
process for medical devices.

ISO/TS 17665-2:2009 Sterilization of health care products - Moist heat - Part 2: Guidance on
the application of ISO 17665-1.
ISO 18472:2006 Sterilization of health care products - Biological and chemical indicators -
Test equipment.
Medical devices utilizing animal tissues and their derivatives - Part 4:
ISO/TR 22442-4:2010 Principles for elimination and/or inactivation of transmissible spongiform
encephalopathy (TSE) agents and validation assays for those processes.
*This standard has been withdrawn and replaced by EN ISO 11137:2006