EN ISO 18472 Sterilization of Health Care Products - Standard for Testing Equipment

EUROLAB, with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of EN ISO 18472 testing. This standard provides informative methods useful in characterizing the performance of biological and chemical indicators for their intended use and routine quality control testing.

This standard specifies test equipment requirements to be used for:

• Test biological indicators for steam, ethylene oxide gas and dry heat sterilization processes for compliance with the requirements given in the ISO 11138 series;
• Test chemical indicators for steam, ethylene oxide gas, dry heat and evaporated hydrogen peroxide sterilization processes for compliance with the requirements given in ISO 11140‑1.

This document also provides informative methods useful in characterizing the performance of biological and chemical indicators for their intended use and routine quality control testing.

This document does not specify test equipment requirements for processes specifically for testing chemical and biological indicators aimed at monitoring isolator and room biodecontamination processes at atmospheric pressure.

ISO 11138‑2:2017, ISO 11138‑3:2017, ISO 11138‑4:2017 and ISO 11140‑1:2014 require the use of the resistometers specified in this document, and these resistometers are used in conjunction with the test methods outlined below. Suitable parts of ISO 11138 series and ISO 11140 series.

Resistometers for low temperature steam and formaldehyde indicators are not included in this document. Test methods using laboratory equipment for low temperature steam and formaldehyde are included in ISO 11138‑5:2017.

Test equipment for testing type 2 (eg Bowie Dick) chemical indicators is specified in ISO 11140‑3:2007, ISO 11140‑4:2007 and ISO 11140‑5:2007.

EUROLAB assists manufacturers with EN ISO 18472 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.