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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Your basket is empty. 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. Learn more about the cookies we use and how to change your settings.

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 These tests are intended to be performed when validating a sterilization process.

We use cookies to make our website easier to use and to better understand your needs. 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.

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 Title in German Sterilisation von Medizinprodukten.

Learn more about the cookies we use and how to change your settings. 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. For this reason, sterilization processes have jso be validated before use, the performance of the process monitored routinely and the equipment maintained.

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Search all products by. You may experience issues viewing this kso in Internet Explorer 9, 10 or Sterilization of medical devices. Essais de sterilite pratiques en cours de validation d’un procede de sterilisation.

Click to learn more. Your basket is empty. It specifies the general 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.

Worldwide Standards We can source any standard from anywhere 11737–2 the world. The 117737-2, easier way to work with standards.

Accept and continue Learn more about the cookies we use and how to change your settings. Tests of sterility performed in the definition, validation and maintenance of a sterilization process Status: Search kso products by. Take the smart route to manage medical device compliance. This website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3.

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 minimized by all practical means. Please download Chrome or Firefox or view our browser tips. An example of the use lso such a test is in establishing a sterilizing dose for sterilization by radiation and for demonstrating the continued validity of this sterilization dose.

Subsequent to this exposure, medical devices are subjected individually to tests of sterility as described in this part of BS EN ISO Please download Chrome or Firefox or view our browser tips. We use cookies to make our website easier to use and to better understand your needs. International Standards specifying procedures for the validation and routine control of uso processes used for sterilization of medical devices isl been prepared.

Worldwide Standards We can source any standard from anywhere in the world.

It includes guidance on the techniques used and on practical aspects of the requirements. Sterile equipment, Sterilization hygieneMedical equipment, Microbiological analysis, Process control, Approval testing, Biological analysis and testing, Microbiology, Assessed reliability, Test equipment, Samples, Specimen preparation.

You may find similar items within these categories by selecting from the choices below:. Find Similar Items This product falls into the following categories. Tests of sterility performed in ixo definition, validation and maintenance of 117337-2 sterilization process. 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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You may experience issues viewing this site in Internet Explorer 9, 10 or Tests of sterility performed in the validation of a sterilization process.

BS EN ISO 11737-2:2000

Find Similar Items This product falls into the following categories. Overview Product Details A sterile product is one which is free of viable microorganisms. A sterile product is one which is free of viable microorganisms.

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. Sterilization of medical devices. Test equipment, Sterilization hygieneSamples, Microbiological analysis, Microbiology, Approval testing, Process control, Biological analysis and testing, Specimen preparation, Medical equipment, Sterile equipment, Assessed reliability.

Moist heat Requirements for the development, validation and routine control of a sterilization process for medical devices. Sterilization is an example of a special process because process efficacy cannot be verified by inspection and testing of the product. Click to learn more. Take the smart route to manage medical device compliance.

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

Tests of sterility performed in the validation of a sterilization process Status: Sterilitaetspruefungen bei der Validierung eines Sterilisationsverfahrens.