Status: Published. Publication date: Edition: 1. Number of pages: 4. Technical Committee.: ISO/TC Sterilization of health care products. ICS. ISO INTERNATIONAL. STANDARD. ISO. First edition. Sterilization of health care products —. Ethylene oxide —. Part 1. Permission can be requested from either ISO at the address below or ISO’s ISO cancels and replaces ISO and.

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It tackles the need for quality systems, staff training and proper safety measures and covers the following points: You may find similar items within these categories by selecting from the choices below:. Overview Product Details What is this standard about? Click to learn more.

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Medical equipment, Sterilization hygieneEthylene oxide, Hygiene, Medical instruments, Sterile equipment, Performance, Performance testing, Quality control, Maintenance, Acceptance approvalVerification, Microbiological analysis, Instructions for use, Personnel, Sterilizers, Management. Anyone responsible for sterilizing medical devices in both industrial and health care settings.

Why should you 1113-1 this standard?

Requirements for the development, validation and routine control of a sterilization process for medical devices Status: Accept and continue Learn more about the cookies we use and how to change your settings. Who is this standard for? Sterilization of health-care products. This international standard sets out how to ensure that medical devices are sterilized effectively using an ethylene oxide sterilization process.

ISO /Amd – Revision of Annex E, Single batch release

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This website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3. It tackles the need for quality systems, staff training and proper safety measures and covers the following points:.

Requirements for the development, validation and routine control of a sterilization process for medical devices. It also adds additional information.

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BS EN ISO 11135:2014

Find Similar Items This product falls into the following categories. Symbols to be used with medical device labels, labelling and information to be supplied General requirements. It describes requirements that, if met, will provide an ethylene oxide sterilization process with appropriate microbiocidal activity intended to sterilize medical devices.