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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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Anyone responsible for sterilizing medical devices in both industrial and health care settings. 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. Take the smart route to manage medical device compliance.

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Search all products by. This international standard sets out how to ensure that medical devices are sterilized effectively using 111351- ethylene oxide sterilization process.

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Sterilization of health-care products. 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.

BS EN ISO 11135:2014

We use cookies to make our website easier to use and to better understand your needs. It tackles the need for quality systems, staff training and uso safety measures and covers the following points:. 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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It tackles the need for quality systems, staff training and proper safety measures and covers the following points: Worldwide 11315-1 We can source any standard from anywhere in the world. Symbols to be used with medical device labels, labelling and information to be supplied General requirements. Requirements for the development, validation and routine control of a sterilization process for medical devices Status: