Manufacturers of medical devices are required to provide EN ISO compliant instructions for use. These instructions must contain validated reprocessing processes for the respective medical device. There are 1 million hospital infections annually in Germany. We say: That's 1 million too much. Involve HygCen at an early stage in the review of your healthcare reprocessing process.
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This includes information for processing prior to use or reuse of the medical device. The provisions of this document are applicable to medical devices that are intended for invasive or other direct or indirect patient contact. Processing instructions are not defined in this document. Rather, this document specifies requirements to assist manufacturers of medical devices in providing detailed processing instructions that consist of the following activities, where applicable:.
This document excludes processing of the following: — non-critical medical devices not intended for direct patient contact; — textile devices used in patient draping systems or surgical clothing; — medical devices specified by the manufacturer for single-use only and supplied ready for use.
Multi-user access to over 3, medical device standards, regulations, expert commentaries and other documents. Worldwide Standards We can source any standard from anywhere in the world. Learn more about the cookies we use and how to change your settings. Online Tools. Search all products by. Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices.
Tourism and related services. Medical tourism. Medical spas. Click to learn more. Overview Product Details What is this standard about? Who is this standard for? Rather, this document specifies requirements to assist manufacturers of medical devices in providing detailed processing instructions that consist of the following activities, where applicable: a initial treatment at the point of use; b preparation before cleaning; c cleaning; d disinfection; e drying; f inspection and maintenance; g packaging; h sterilization; i storage; j transportation.
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Learn more. The faster, easier way to work with standards. Learn how. Symbols to be used with medical device labels, labelling and information to be supplied General requirements BS EN ISO Sterilization of health care products. General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices BS EN ISO Sterilization of health care products.
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EN ISO 17664
While this probability can be reduced to a very low number, it can never be reduced to zero. A lot of single-use medical devices, such as cannulas, surgical gloves and plasters, must be processed, or to be more precise sterilized, before they can be used. This processing is usually performed by the manufacturers or their service providers. However, reusable medical devices, such as bedpans, surgical gowns, surgical instruments e.
ISO specifies the information to be provided by the medical device manufacturer on the processing of medical devices claimed to be resterilizable, and medical devices intended to be sterilized by the processor. ISO specifies requirements for the information to be provided by the medical device manufacturer, so that the medical device can be processed safely and will continue to meet its performance specification. Requirements are specified for processing that consists of all or some of the following activities:. When providing instructions for these activities, medical device manufacturers are expected to be aware of the training and knowledge of procedures, and of the processing equipment available to the persons likely to be responsible for processing.
BS EN ISO 17664:2017
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