ISO 11737-2 PDF

STANDARD. ISO. Second edition. Sterilization of medical devices —. Microbiological methods —. Part 2: Tests of sterility performed in the. ISO. /(R) Sterilization of medical devices – Microbiological methods – Part 2: Tests of sterility performed in the definition, validation and. BS EN ISO Sterilization of medical devices – Microbiological methods Part 2: Tests of sterility performed in the definition, validation and maintenance of .

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BS EN ISO 11737-2:2009

Learn more about the cookies we use and how to change your settings. Sterilitaetspruefungen bei der Validierung eines Sterilisationsverfahrens. Your basket is empty. It includes guidance on the techniques used and on practical aspects of the requirements.

A sterile product is one which is free of viable microorganisms.

NBN EN ISO 11737-2

You may find similar items within these categories by selecting from the choices below:. Take the smart route to manage medical device compliance.

Find Similar Items This product falls into the following categories. An example of the use of such a test is in establishing a sterilizing dose for sterilization by radiation and for demonstrating the continued validity of this sterilization dose.

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NBN EN ISO | NBN

Overview Product Details A sterile product is one which is free of viable microorganisms. 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 An element of this validation may consist of exposing medical devices to the sterilizing agent when the extent of treatment has been reduced relative to that which will be used in routine processing in order to provide a knowledge of the resistance to the agent of the microbial contamination as it occurs naturally on medical devices.

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Tests of sterility performed in the definition, validation and maintenance of a sterilization process. This website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3. Essais de sterilite pratiques en cours de validation d’un procede de sterilisation. It follows that the sterility of any one item in a population of items subjected to sterilization processing cannot be guaranteed, and the sterility of the processed population of items has to be defined in terms of the probability of the existence of a non-sterile item in that population.

Such product items are non-sterile. Test equipment, Sterilization hygieneSamples, Microbiological analysis, Microbiology, Approval testing, Process control, Biological analysis and testing, Specimen preparation, Medical equipment, Sterile equipment, Assessed reliability.

Sterilization of medical devices. Moist heat Requirements for the development, validation and routine control of a sterilization process for medical devices. May Replaced By: Subsequent to this exposure, medical devices are subjected individually to tests of sterility as described in this part of BS EN ISO We use cookies to make our website easier to use and to better understand your needs.

Sterilization is an example of a special process because process efficacy cannot be verified by inspection and testing of the product. Worldwide Standards We can source any standard from anywhere in the world. Customers who bought this product also bought BS EN You may experience issues viewing this site in Internet Explorer 9, 10 or Find Similar Items This product falls into the following categories. The purpose of sterilization processing is to inactivate the microbiological contaminants and thereby transform the non-sterile items into sterile ones.

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International Standards specifying procedures for the validation and routine control of the processes used for sterilization of medical devices have been prepared. Tests of sterility performed in the validation of a sterilization process.

It specifies the 1737-2 criteria for tests of sterility on medical devices which have been exposed to a treatment with the sterilizing agent that is a fraction of the specified sterilization process. This website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3.

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You may find similar items within these categories by selecting from the choices below:. Sterilisation des dispositifs medicaux.

These tests are intended to be performed when validating a sterilization process. Even so, product 17137-2 produced under standard manufacturing conditions in accordance with the requirements for quality systems for medical devices may, prior to sterilization, have microorganisms on them, albeit in low numbers.

Take the smart route to manage medical device compliance.

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