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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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This website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3. Overview Product Details What is this standard about? Are there other options for dose setting besides VDmax25 and Method 1? In order to test a dose for SALone million products would need to be irradiated and sterility tested.

If the sterility test exhibits a failing number of positive tests, the verification dose experiment can be performed again and samples re-tested. Take the smart route to manage medical device compliance. You may experience issues viewing this site in Internet Explorer 9, 10 or These TIRs reflect common industry practices that evolve from an accumulated process knowledge base.

If one of these validations establishes my minimum dose, how do I establish a maximum dose? Please download Chrome or Firefox or view our browser tips. The radiation resistance of B. Establishing the sterilization dose Status: Do not sterility test the samples. Search all products by. This standard contains guidelines to specify the methods that can be used to determine the minimum sterilisation dose.

Each method has specific limitations and requirements that must be fully investigated before selection. Sterilization of Medical devices-Microbiological methods-Part 1: Do I need a Biological Indicator?

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You may find similar items within these categories by selecting from the choices below:. This part of ISO specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose.

The standard has been systematically reviewed by experts to ensure its continued market relevance and adherence to clinical best practice and now includes significant technical changes such as: Bacillus pumilus, a spore-forming microorganism, served for many years as a biological indicator to test for sterility.

Its use today has been discontinued. What are the basic steps? Sterilization of health care products-Radiation-Part 3: It also defines product families for establishing sterilization doses and gives details on a sterilization dose audit.

Why is the verification dose experiment performed at a lower Sio than the sterilization dose? When gamma irradiation is selected for product sterilization, the dose at which the product is irradiated must be established and validated in accordance with appropriate AAMI standards.

Which validation is right for me? The unit of measurement is CFU: Pre- and postirradiation properties related to functionality and appearance must be evaluated to determine maximum dose.

Probability of a viable microorganism being present on a product unit after sterilization. Send new samples for irradiation prior to sterility testing.

The faster, easier way to work with standards. This is considered an ixo. Have bioburden testing performed on 10 products from three different batches, for a total of 30 products. Contained in and TIR 33 are additional methodsincluding Method 2 11317-2 dosing and VD max for selected doses of kGy in 2.

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This must be retested if any changes are made to the product. Accelerated iwo and package testing are additional tests to be considered for product irradiated at the maximum dose.

EN ISO 11137-2:2015

This Method should be used when the lowest possible sterilization dose is desired due to cost considerations, use of gamma sensitive materials, or when the bioburden count is above CFU. Bioburden counts must be CFU or less. Population of viable microorganisms on a product.

Your basket is empty. 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 jso means of substantiation Changes to the incremental increases in the bioburden values have been included in Table 6.

Medical equipment, Sterilization hygieneRadiation, Ionizing radiation, Gamma-radiation, Electron beams, X-rays, Radiation measurement, Verification, Quality control, Quality assurance, Medical technology, Medical instruments, Sterile equipment, Mathematical calculations.

Performed early in product qualification, materials can be screened for compatibility with irradiation.

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

Who is this standard for? Method 1 from determines the lowest 11137–2 dose necessary for the determined bioburden population. It is recommended that even without changes that the test be repeated every years to account for any changes in raw materials or suppliers.