Is en ISO 11135?

BS EN ISO 11135:2014+A1:2019. This standard details how to develop, validate and reliably reproduce an ethylene oxide sterilization process for medical devices that has appropriate microbicidal activity. In particular, this edition of the standard introduces amendments that clarify Annex E on single batch release.

What is EO sterilization?

Ethylene oxide (also known as EO or EtO) is a low temperature gaseous process widely used to sterilize a variety of healthcare products, such as single-use medical devices.

How do you validate EtO sterilization?

The common approach for ethylene oxide sterilization (EO sterilization) validation is referred to as the “Overkill Approach,” in which a biological indicator, placed in the most resistant location of the device, is deactivated or killed in one-half the time of the routine sterilization cycle.

What is half cycle in sterilization?

Half Cycle – The load is then processed in a cycle which has been selected or designed by the EO sterilization specialist to deliver less lethality at one half the routine cycle exposure time, as compared to the cycle which will be used for routine processing.

What is ISO 11737?

ISO 11737-1:2018 specifies requirements and provides guidance on the enumeration and microbial characterization of the population of viable microorganisms on or in a health care product, component, raw material or package.

What is a process challenge device?

Process challenge devices (PCDs), according to ANSI/AAMI/ISO TIR11139:2006—Sterilization of health care products—vocabulary, are devices “designed to constitute a defined resistance to a sterilization process and used to assess performance of the process.”1 Healthcare facilities need to monitor and predict whether they …

What is dunnage in sterilization?

Dunnage, by definition, is simulated product to represent a worst-case load for the validation. Dunnage should be product components, products, and packaging that are representative of what you trying to validate.

What is autoclave cycle?

During autoclaving, surgical handtools are exposed to 100% humidity, 135ºC (275ºF) and pressure variations for up to 18 minutes. Most autoclaves also have additional vacuum cycles to facilitate steam penetration and kill viruses, fungi, bacteria, and spores that can hide in microscopic cavities on the device.

What are the requirements for ISO 11135-1?

ISO 11135-1:2007 specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices.

How to requalify ethylene oxide for ISO 11135?

Requalification –ISO 11135 •Have a documented procedure that requires an annual review of validation (IQ, OQ, PQ) •Use the Requalification Decision Tree detailed in D.12.3.2 The simplest route to compliance

How does ISO collaborate with the International Electrotechnical Commission?

ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1.

Who are the international organizations that work with ISO?

International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.