BS EN ISO 14161:2009
Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results

Standard No.

BS EN ISO 14161:2009

Release Date

2010

Published By

British Standards Institution (BSI)

Status

Be replaced 2010-01

Replace By

BS EN ISO 14161:2010

Latest

BS EN ISO 14161:2010

Replace

08/30149503 DC:2008 BS EN ISO 14161:2001

Scope

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. NOTE 1 See, for example, the ISO 11138 series. NOTE 2 The general information provided in this International Standard can have useful application for processes and biological indicators not currently addressed by existing International Standards, e.g., new and developing sterilization processes. This International Standard does not consider those processes that rely solely on physical removal of microorganisms, e.g., filtration. This International Standard is not intended to apply to combination processes using, for example, washer disinfectors or flushing and steaming of pipelines. This International Standard is not intended to apply to liquid sterilization processes.

BS 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 11138-1:2006 Sterilization of health care products - Biological indicators - Part 1: General requirements
• 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 14937 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
• 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

BS EN ISO 14161:2009 history

• 2010 BS EN ISO 14161:2010 Sterilization of health care products. Biological indicators. Guidance for the selection, use and interpretation of results
• 2010 BS EN ISO 14161:2009 Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results