ISO 11137-2 PDF

Buy EN ISO STERILIZATION OF HEALTH CARE PRODUCTS – RADIATION – PART 2: ESTABLISHING THE STERILIZATION DOSE (ISO. ISO Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose. ANSI/AAMI/. ISO Sterilization of health care products — Radiation —. Part 2: Establishing the sterilization dose. American. National. Standard.

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Accelerated aging and package testing are additional tests to be considered for product irradiated at the maximum dose. Accept and continue Learn more about the cookies we use and how to change your settings.

This is considered an overdose. Irradiating your product at a dose approximately 2. Have bioburden testing performed on 10 products from three different batches, for a total of 30 products. Bacillus pumilus, a spore-forming microorganism, served for many years as a biological indicator to test for sterility.

The radiation resistance of B. This part of ISO specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose.


BIs also do not accurately represent natural form of bioburden on a product spore strip vs. Contained in and TIR 33 are additional methodsincluding Method 2 incremental dosing and VD max for selected doses of kGy in 2. You may experience issues viewing this site in Internet Explorer 9, 10 or You may find similar items within these categories by selecting from the choices below:.

EN ISO – Sterilization of health care products – Radiation – Part 2: –

Why is the verification dose experiment performed at a lower SAL than the sterilization dose? If one of these validations establishes my minimum dose, how do I establish a maximum dose?

Your basket is empty. This standard contains guidelines to specify the methods that can be used to determine the minimum sterilisation dose.

Gamma Sterilization Validations VDmax 25 and Method 1

This must 111337-2 retested if any changes are made to the product. The unit of measurement is CFU: Which validation is right for me? Pre- and postirradiation properties related to functionality and appearance must be evaluated to determine maximum dose. Do not sterility test the samples.

The number of samples required for this testing should be confirmed with the laboratory performing the testing usually Do I need a Biological Indicator? Overview Product Details What is this standard about? Search all products by. Sterilization of health care products-Radiation-Part 3: Performed early in product qualification, materials 1113-72 be screened for compatibility with irradiation. Establishing the sterilization dose Status: In the context of irradiation sterilization, 111377-2 is determined immediately prior to sterilization.


Gamma Sterilization Validations: VDmax 25 and Method 1 FAQ | STERIS AST

Method 1 from determines the lowest sterilization dose necessary for the determined bioburden population. Who is this standard for?

Its use today has been discontinued. A correction of the language isk to describe the requirements for interpretations of results during a verification dose experiment Amendments to methods of dose establishment and means of substantiation Changes to the incremental increases in the bioburden values have been included in Table 6. In order to test a dose for SALone million products would need to be irradiated and sterility tested.