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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EN ISO 11137-2:2015

Find Similar Items This product falls into the following categories. Do not sterility test the samples.

In order to test a dose for SALone million products would need to be irradiated and sterility tested. Click to learn more. Establishing the 11137-22 dose Status: This is considered an overdose. Requirements for the development, validation and routine control of a sterilization process for medical devices BS EN This Method should be used when the lowest possible sterilization dose is desired due to kso considerations, use of gamma sensitive materials, or when the bioburden count is above CFU.

Bacillus pumilus, a spore-forming microorganism, served for many years as a biological indicator to test for sterility. A correction of the language used 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.


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BS EN ISO 11137-2:2015

Test performed with selected microorganisms to demonstrate the presence of substances that inhibit the multiplication of these microorganisms. The unit of measurement is CFU: This part of ISO specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose.

This must be retested 11173-2 any changes are made to the product. Each method has specific limitations and requirements that must be fully investigated before selection.

Performed early in product qualification, materials can be screened for compatibility with irradiation. Contained in and TIR 33 are additional methodsincluding Method 2 incremental dosing and VD max for selected doses of kGy in 2.

ANSI/AAMI/ISO – Sterilization of Health Care Products Package

Are there other options for dose setting besides VDmax25 and Method 1? Sterilization of health care products-Radiation-Part 1: Accept and continue Learn more about the cookies we use and how to change your settings. We use cookies to make our website easier to use and to better understand your needs. In the context of irradiation sterilization, bioburden is determined immediately prior to sterilization.

This isk contains guidelines to specify the methods that can be used to determine the minimum sterilisation dose.

  JIS G3201 PDF

Who is this standard for? The radiation resistance of B.

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

The faster, easier way to work with standards. Your basket is empty. Population of viable microorganisms on a product. Do I need a Biological Indicator? Have bioburden testing performed on 10 products from three different batches, for a total of 30 products.

Measure of the ability of a specified technique to remove microorganisms from product. Sterilization of health care products-Radiation-Part 3: Its use today has been discontinued.

Accelerated aging and package testing are additional tests to be considered for product irradiated at the maximum dose. Worldwide Standards We can source any standard from anywhere in isi world.

BIs also do not accurately represent natural form of bioburden on a product spore strip vs. Method 1 from determines the lowest sterilization dose necessary for the determined bioburden population. 11137-22 is recommended that even without changes that the test be repeated every years to account for any changes in raw materials or suppliers.