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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Anyone responsible for sterilizing medical devices in both industrial and health care settings.
Sterilization of health-care products. Search all products by.
The faster, easier way to work with standards. Overview Product Details What is this standard about?
You may find similar items within these categories by selecting from the choices below:. Symbols to be used with medical device labels, labelling and information to be supplied General requirements.
ISO /Amd – Revision of Annex E, Single batch release
Why should you use this standard?
BS EN ISO 11135:2014
kso Take the smart route to manage medical device compliance. This international standard sets out how to ensure that medical devices are sterilized effectively using an ethylene oxide sterilization process.
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Learn more about the cookies we use and how to change your settings. It describes requirements that, if met, will provide an ethylene oxide sterilization process with appropriate microbiocidal activity intended to sterilize medical devices. Requirements for the development, validation and routine control of a sterilization process for io devices Status: It tackles the need for quality 1135-1, staff training and proper safety measures and covers the following points:.
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. Click to learn more.
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It tackles the need for quality systems, staff training and proper safety measures and covers the following points: