EN ISO 11138-5:2017
Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes

Standard No.

EN ISO 11138-5:2017

Release Date

2017

Published By

European Committee for Standardization (CEN)

Latest

EN ISO 11138-5:2017

Replace

FprEN ISO 11138-5:2016

EN ISO 11138-5:2017 Referenced Document

• EN 14180:2014 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
• ISO 11138-1:2017 Sterilization of health care products - Biological indicators - Part 1: General requirements
• ISO 14161:2009 Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results
• ISO 14937:2009 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 25424:2009 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices

EN ISO 11138-5:2017 history

• 2017 EN ISO 11138-5:2017 Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
• 2006 EN ISO 11138-5:2006 Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes