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? This international standard sets out how 111135-1 ensure that medical devices are sterilized effectively using an ethylene oxide sterilization process. Sterilization of health-care products.
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BS EN ISO 11135:2014
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.
Worldwide Standards We can source any standard from anywhere in the world. Search all products by. Learn more about the cookies we use and how to change your settings. It also adds additional information. Anyone responsible for sterilizing medical devices in both industrial and health care settings. 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 Status: It describes requirements that, if met, will provide an ethylene oxide sterilization process with appropriate microbiocidal activity intended to sterilize medical devices. The faster, easier way to work with standards. You may find similar 111351 within these categories by selecting from the choices below:.
ISO /Amd – Revision of Annex E, Single batch release
Who is this standard for? Overview Product Details What is this standard about? Symbols to be used with medical device labels, labelling and information to be supplied General requirements.
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