International Organization for Standardization (ISO)
Latest
ISO 11140-1:2014
ISO 11140-1:2014 Referenced Document
EN 13060:2004 Small steam sterilizers Incorporates Amendment A2: 2010
EN 14180:2014 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
EN 1422:2014 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
EN 285:2006 Sterilization - Steam sterilizers - Large sterilizers (Incorporates Amendment A2: 2009)
EN 550:1994 Sterilization of Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization
EN 552:1994 AMD A1 Sterilization of Medical Devices - Validation and Routine Control of Sterilization by Irradiation (Incorporates Amendment A1: 1999)
EN 556-1:2001 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices*, 2023-12-23 Update
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
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
ISO 11137-2:2013 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
ISO 11137-3:2006 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects
ISO 11138-1:2006 Sterilization of health care products - Biological indicators - Part 1: General requirements
ISO 11138-2:2006 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes
ISO 11138-3:2006 Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes
ISO 11138-4:2006 Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes
ISO 8601:2004 Data elements and interchange formats - Information interchange - Representation of dates and times
ISO 9001:2008 Quality management systems - Requirements
ISO 11140-1:2014 history
2014ISO 11140-1:2014 Sterilization of health care products - Chemical indicators - Part 1: General requirements
2005ISO 11140-1:2005 Sterilization of health care products - Chemical indicators - Part 1: General requirements
1998ISO 11140-1:1995/Amd 1:1998 Sterilization of health care products - Chemical indicators - Part 1: General requirements; Amendment 1
1995ISO 11140-1:1995 Sterilization of health care products - Chemical indicators - Part 1: General requirements