ISO 11140-1:2014
Sterilization of health care products - Chemical indicators - Part 1: General requirements

Standard No.
ISO 11140-1:2014
Release Date
2014
Published By
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

  • 2014 ISO 11140-1:2014 Sterilization of health care products - Chemical indicators - Part 1: General requirements
  • 2005 ISO 11140-1:2005 Sterilization of health care products - Chemical indicators - Part 1: General requirements
  • 1998 ISO 11140-1:1995/Amd 1:1998 Sterilization of health care products - Chemical indicators - Part 1: General requirements; Amendment 1
  • 1995 ISO 11140-1:1995 Sterilization of health care products - Chemical indicators - Part 1: General requirements
Sterilization of health care products - Chemical indicators - Part 1: General requirements



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