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 .

Author: Malakinos Dahn
Country: Azerbaijan
Language: English (Spanish)
Genre: Spiritual
Published (Last): 11 August 2008
Pages: 136
PDF File Size: 12.6 Mb
ePub File Size: 12.57 Mb
ISBN: 670-1-89493-523-3
Downloads: 7034
Price: Free* [*Free Regsitration Required]
Uploader: Malazuru

Please download Chrome or Firefox or view our browser tips. Such product items are non-sterile. 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. For a given treatment, the probability of survival is determined by the number and resistance of 11773-2 and by the environment in which the organisms exist during treatment.

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. Sterilization is an example of a special process because process efficacy cannot be verified by inspection and testing of the product.

International Standards specifying procedures for the validation and routine control of the processes used for sterilization of medical devices have been prepared. The faster, 11737–2 way to work with standards.

BS EN ISO 11737-2:2009

You may find similar items within these categories by selecting from the choices below:. Essais de sterilite pratiques en cours 11377-2 validation d’un procede de sterilisation. 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.

We use cookies to make our website easier to use and to better understand your needs. Essais de sterilite pratiques en cours de validation d’un procede de sterilisation Title in German Sterilisation von Medizinprodukten. Sterilisation des dispositifs medicaux. Sterilization of medical devices. May Replaced By: Accept and continue Learn more about the cookies we isp and how to change your settings.

  LIBRO PLAZOLA HABITACIONAL PDF

NBN EN ISO | NBN

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

Your basket is empty. Worldwide Standards We oso source any standard from anywhere in the world. Sterilization of medical devices. This website is best 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 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 Search all products by.

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. The purpose of sterilization 117337-2 is to inactivate the microbiological contaminants and thereby transform the non-sterile items into sterile ones.

Click to learn more. 1137-2 Similar Items This product falls into the following categories. Worldwide Standards We can source any standard from anywhere in the world.

Take the smart route to manage medical device compliance. Test equipment, Sterilization hygieneSamples, Microbiological analysis, Microbiology, Approval testing, Process control, Biological analysis and testing, Specimen isoo, Medical equipment, Sterile equipment, Assessed reliability. Sterile equipment, Sterilization hygieneMedical equipment, 11773-2 analysis, Io control, Approval testing, Biological analysis and testing, Microbiology, Assessed reliability, Test equipment, Samples, Specimen preparation.

Learn more about the cookies we use and how to change your settings. Click to learn more. 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: It includes guidance on the techniques used and on practical aspects of the requirements.

  ALCATEL A4400 PDF

Learn more about the cookies we use and how to change your settings. You may find similar items within these categories by selecting from the choices below:.

Moist heat Requirements for the development, validation and routine control of a sterilization process for medical devices. 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. Sterilitaetspruefungen bei der Validierung eines Sterilisationsverfahrens. These tests are intended to be performed when validating a sterilization process. Subsequent to this exposure, medical devices are subjected individually to tests of sterility as described in this part of BS EN ISO You may experience issues viewing this site in Internet Explorer 9, 10 or Tests of sterility performed in the validation of a sterilization process Status: Overview Product Details A sterile product is one which is free of viable microorganisms.

Search all products by.

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. Find Similar Items This product falls into the following categories.

For this reason, sterilization processes have to be validated before use, the performance of the process monitored routinely and the equipment maintained. Customers who bought this product also bought BS EN