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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Requirements for the development, validation and routine control of a sterilization process for medical devices BS EN Measure of the ability of a specified technique to remove microorganisms from isl.

For both types of validations, the first step is identical: Please download Chrome or Firefox or view our browser tips. 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: The unit of measurement is CFU: Accelerated aging and package testing are additional tests to be considered for product 1117-2 at the maximum dose.

Each method has specific limitations and requirements that must be fully investigated before selection.

In the context of irradiation sterilization, bioburden is determined immediately prior to sterilization.

BIs also do not accurately represent natural form of bioburden on a product spore strip vs. Sterilization of health care products-Radiation-Part 2: Are there other options for dose setting besides VDmax25 and Method 1? Sterilization of health care products-Radiation-Part 1: Method 1 from determines the lowest sterilization dose necessary for the determined bioburden population. Pre- and postirradiation properties related to functionality and appearance must be evaluated to determine maximum dose.


You may experience issues viewing this site in Internet Explorer 9, 10 or The radiation resistance of B. Take the smart route to manage medical device compliance. In order to test a dose for SALone million products would need to be irradiated and sterility tested.

Accept and continue Learn more about the cookies we use and how to change your settings. If the sterility test exhibits a failing number of positive tests, the verification dose experiment can be performed again and samples re-tested.

Establishing the sterilization dose Status: If one of these validations establishes my minimum dose, how do I establish a maximum dose?

Irradiating your product at a dose approximately 2. Why is the verification dose experiment performed at a lower SAL than the sterilization dose?

It is recommended that even without changes that the test be repeated every years to account for any changes in raw materials uso suppliers. This part of ISO specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose.

These TIRs reflect common industry practices that evolve from an accumulated process knowledge base. Population of viable microorganisms on a product.

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

Contained in and TIR 33 are additional methodsincluding Jso 2 incremental dosing and VD max for selected doses of kGy in 2. Performed early in product qualification, materials can be screened for compatibility with irradiation. Do not sterility test the samples. Bioburden counts must be CFU or less.


We use cookies to 1137-2 our website easier to use and to better understand your needs. This website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3. Worldwide Standards We can source any standard from anywhere in the world. Overview Product Details What is this standard about?

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

Guidance on dosimetric aspects of development, validation and routine control. Sterilization of Medical devices-Microbiological methods-Part 1: Sterilization of health care products-Radiation-Part 3: Do I need a Biological Indicator? Have bioburden testing performed on 10 isi from three different batches, for a total of 30 products.

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 izo the incremental increases in the bioburden values have been included in Table 6.

Search all products by. 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.

EN ISO 11137-2:2015

Its use today has been discontinued. Click to learn more. Test performed with selected microorganisms to demonstrate the presence of substances that inhibit the multiplication of these microorganisms. What are the basic steps?