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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Sterilization of health-care products. It tackles the need for quality systems, staff training and proper safety measures and covers the following points:.
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Requirements for the development, validation and routine control of a sterilization process for medical devices. You may experience issues viewing this site in Internet Explorer 9, 10 or Find Similar Items 1113-51 product falls into the following categories. The faster, easier way to work with standards.
Anyone responsible for sterilizing medical devices in both industrial and health care settings. Who is this standard for? This international standard sets out how to ensure that medical devices are sterilized effectively using an ethylene oxide sterilization process.
Your basket is empty. 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.
ISO /Amd – Revision of Annex E, Single batch release
Take the smart route to manage medical device compliance. Overview Product Details What is this standard about?
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BS EN ISO 11135:2014
It describes requirements that, if met, will provide an ethylene oxide sterilization process with appropriate microbiocidal activity 1115-1 to sterilize medical devices. 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: