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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Ieo international standard sets out how to ensure that medical devices are sterilized effectively using an ethylene oxide sterilization process.
Anyone responsible for sterilizing medical devices in both industrial and health care settings. It describes requirements that, if met, will provide an ethylene oxide sterilization process with appropriate microbiocidal activity intended to sterilize medical devices.
BS EN ISO 11135:2014
It tackles the need for quality systems, staff training and proper safety measures and covers the following points:. It also adds additional information.
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Requirements for the development, validation and routine control of a sterilization process for medical devices Status: Click to learn more. Overview Product Details What is this standard about? Who is this standard for? Why should you use this standard?
ISO /Amd – Revision of Annex E, Single batch release
It tackles the need 11153-1 quality systems, staff training and proper safety measures and covers the following points: Your basket is empty. Take the smart route to manage medical device compliance. The faster, easier way to work with standards. Symbols to be used with medical device labels, labelling and information to be supplied General requirements.
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Requirements for the development, validation and routine control of a sterilization process for medical devices. 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.