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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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Sterilisation des dispositifs medicaux. Search all products by. These tests are intended to be performed when validating a sterilization process. Such product items are non-sterile.

Take the smart route to manage medical device compliance. General requirements for characterization of a sterilizing agent and the development, validation and routine control of a isk process for medical devices BS EN ISO Sterilization is an example of a special process because process efficacy cannot be verified by inspection and testing of the product.

Test equipment, Sterilization hygieneSamples, Microbiological analysis, Microbiology, Approval testing, Process 1177-2, Biological analysis and testing, Specimen preparation, Medical equipment, Sterile equipment, Assessed reliability. Accept and continue Learn more about the cookies we use and how to change your settings. You may experience issues viewing this site lso Internet Explorer 9, 10 or 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 111737-2 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.

May Replaced By: Worldwide Standards We can source any standard from anywhere in the world. The purpose of sterilization processing is to inactivate the microbiological contaminants and thereby transform the non-sterile items into sterile ones.

Subsequent to this exposure, medical devices are subjected individually to tests of sterility as described in this part of BS EN ISO Tests of sterility performed in the definition, validation and maintenance of a sterilization process Status: Overview Product Details A sterile product is one which is free of viable microorganisms. This website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3. Please download Chrome or Firefox or view our browser tips.

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BS EN ISO 11737-2:2009

For a given treatment, the probability of survival is determined by the number and resistance of microorganisms and by the environment in which the organisms exist during treatment. Find Similar Items This product falls into the following categories.

Your basket is empty. Click to learn more. The International Standards for sterilization of medical devices require, when it is necessary to supply a sterile product item, that adventitious microbiological contamination of a medical device from all sources be oso by all practical means. The 1137-2, easier way to work with standards. Take the smart route to manage medical device compliance.

Click to learn more. Essais de sterilite pratiques en cours de validation d’un procede de sterilisation. Moist heat Requirements for the development, validation and routine control of a 11737–2 process for medical devices. Tests of sterility performed in the validation of a sterilization process.

The ISO series of standards designates certain processes used in manufacture as ‘special’ if the results cannot be fully verified by subsequent inspection and testing of the product.

Customers who bought this product also bought BS EN For this reason, sterilization processes have to be validated before use, the performance of the process monitored routinely and the equipment maintained. Worldwide Standards We can source any standard from anywhere in the world.

BS EN ISO 11737-2:2000

Find Similar Items This product falls into the following categories. International Standards specifying procedures for the validation and routine control of the processes used for sterilization of medical devices have been prepared. Learn more about the cookies we use and how to change your settings.

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isi You may find similar items within these categories by selecting from the choices below:. It specifies the general criteria for isl 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.

Even so, product items 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.

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This website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3. 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.

Sterilization of medical devices. Tests of sterility performed in oso definition, validation and maintenance of a sterilization process. Sterilization of medical devices. Sterile equipment, Sterilization hygieneMedical equipment, Microbiological analysis, Process control, Approval testing, Biological analysis and testing, Microbiology, Assessed reliability, Test equipment, Samples, Specimen preparation.

We use cookies 11737-22 make our website iao to isp and to better understand your needs. Please download Chrome or Firefox or view our browser tips. Essais de sterilite pratiques en cours de validation d’un procede de sterilisation Title in German Sterilisation von Medizinprodukten.

You may experience issues viewing this site in Internet Explorer 9, 10 or Accept and continue Learn more about the cookies we use and how to change your settings. Your basket is empty.

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