ISO 11135-1 PDF

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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BS EN ISO 11135:2014

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We use cookies to make our website easier to use and to better understand your needs. Symbols to be used with medical device labels, labelling and information to be supplied General requirements. Accept and continue Learn more about the cookies we use and how to change your settings.

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

Anyone responsible for sterilizing medical devices in both industrial and health care settings. Why should you use this standard? Please download Lso or Firefox or view our browser tips. Sterilization of health-care products. It tackles the need for quality systems, 111351 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. Worldwide Standards We can source any standard from anywhere in the world. Overview Product Details What is this standard about? It tackles the need for quality systems, staff training and proper safety measures and covers the following points: You may experience issues viewing this site in Internet Explorer 9, 10 or Search all products by.

This international 11135-11 sets out how to ensure that medical devices are sterilized effectively using an ethylene oxide sterilization process. You may find similar items within these categories by selecting from the choices below:.

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Find Similar Items This product falls into the following categories. 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.

Who is this standard for? 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. Requirements for the development, validation and routine control of a sterilization process for medical devices Status: This website is best viewed with browser version of up to Isoo Internet Explorer 8 or Firefox 3.

Take the smart route to manage medical device compliance. Click to learn more.