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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It tackles the need for quality systems, staff training and proper safety measures ios covers the following points:. Your basket is empty. Learn more about the cookies we use and how to change your settings.
Search all products by. Who is this standard for? This international standard sets out how oso ensure that medical devices are sterilized effectively using an ethylene oxide sterilization process.
ISO /Amd – Revision of Annex E, Single batch release
Accept and continue Learn more about the cookies we use and how to change your settings. Anyone responsible for sterilizing medical devices in both industrial and health care settings.
Overview Product Details What is this standard about? Find Similar Items This product falls into the following categories. It tackles the need for quality systems, staff training and proper 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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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. This website is 11315-1 viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3.
You may experience issues viewing this site in Internet Explorer 9, 10 or 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
Why should you use this standard? It also adds additional information. Requirements for the development, validation and routine control of a sterilization process for medical devices. Requirements for the development, validation and routine control of a sterilization process for medical devices Status: Please download Chrome or Firefox or view our browser tips.
Click to learn more. Take the smart route to manage medical device compliance.