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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Why should you use this standard? Search all products by. Take the smart route to manage medical 11135-1 compliance. Click to learn more.

It tackles the need for quality systems, staff training and proper safety measures and covers the following points: Find Similar Items This product falls into the following categories.

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. Overview Product Details What is this standard about?

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Requirements for the development, validation and routine control of a sterilization process for medical devices Status: Accept and continue Isl more about the cookies we use and how to change your settings.

BS EN ISO 11135:2014

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You may find similar items within these categories by selecting from the choices below:. It 11135–1 the need for quality systems, staff training and proper safety measures and covers the following points:.

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

Symbols to be used with medical device labels, labelling and information to be supplied General requirements. Anyone responsible for sterilizing medical devices in both industrial and health care settings. The faster, easier way to work with standards. It also adds additional information. It describes requirements that, if met, will provide an ethylene oxide sterilization process with appropriate microbiocidal activity intended to sterilize medical devices.

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Requirements for the development, validation and routine control of a sterilization process for medical devices. We use cookies to make our website easier to use and to better understand your needs. You may experience issues viewing this site in Internet Explorer 9, 10 or Sterilization of health-care products.

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This international standard sets out how to ensure that medical devices are sterilized effectively using an ethylene oxide sterilization process.