EN ISO 14161:2009 Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results (ISO 14161:2009)
This International Standard provides guidance for the selection, use and interpretation of results from application of biological indicators when used in the development, validation and routine monitoring of sterilization processes.This International Standard applies to biological indicators for which International Standards exist.
EN ISO 14161:2009 Referenced Document
ISO 11135-1 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 11138-2 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes*， 2017-03-01 Update
ISO 11138-3 Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes*， 2017-02-28 Update
ISO 11138-4 Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes*， 2017-03-01 Update
ISO 11138-5 Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes*， 2017-03-01 Update
ISO 11737-1 Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products — Amendment 1*， 2021-05-19 Update
ISO 17665-1 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 18472:2006 Sterilization of health care products - Biological and chemical indicators - Test equipment
EN ISO 14161:2009 history
2009EN ISO 14161:2009 Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results (ISO 14161:2009)
2000EN ISO 14161:2000 Sterilization of Health Care Products - Biological Indicators - Guidance for the Selection, Use and Interpretation of Results ISO 14161:2000