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Standard for chlorine dioxide sterilization of medical devices

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Guest user Created:   May 25, 2021 Last commented:   May 26, 2021

Standard for chlorine dioxide sterilization of medical devices

What standard to I require for chlorine dioxide sterilization of medical devices?

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić May 26, 2021

To my knowledge, there is no ISO standard for performing chlorine dioxide sterilization. However, besides that kind of standard, each sterilization process and sterile medical device must correspond to the following harmonized and state-fo.the-art standards:

ISO 18472:2018 Sterilization of health care products — Biological and chemical indicators — Test equipment
EN ISO 11737-2:2020 Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation, and maintenance of a sterilization process (ISO 11737-2:2019)’
EN 556-1:2001 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
EN ISO 11140-1: 2014 Sterilization of health care products - Chemical indicators - Part 1: General requirements
EN ISO 11140-3:2009 Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and ****-type steam penetration test
EN ISO 11737-1: 2018 Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products
EN ISO 11737-2:2019 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation, and maintenance of a sterilization process
EN 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

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May 25, 2021

May 26, 2021