ISO 11137-2:2013

Name: ISO 11137-2:2013 — Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
SKU: ISO 11137-2:2013
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Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose

Название (английский):

ISO 11137-2:2013

Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 68
Дата публикации:: 21 мая 2013 г.
Издание:: ISO IS 11137 edition 3 version 1
ICS:: 11.080.01

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Описание (английский):

ISO 11137-2:2013 specifies methods for determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization dose to achieve a sterility assurance level, SAL, of 10−6. ISO 11137-2:2013 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose. ISO 11137-2:2013 defines product families for sterilization dose establishment and sterilization dose audit.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

ISO 11137-2:2013 - “Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose” specifies validated methods to determine the minimum radiation dose required to achieve a specified sterility requirement. The standard describes procedures to set a product‑specific sterilization dose, to substantiate preselected doses of 25 kGy or 15 kGy for a Sterility Assurance Level (SAL) of 10−6, and to perform routine sterilization dose audits that demonstrate continued effectiveness. It also defines how to group products into product families for dose setting and audit purposes.

Key topics and requirements

Dose‑setting methods: Uses Methods 1 and 2 (bioburden‑based and fraction‑positive incremental dosing approaches) to predict the dose needed to reach a targeted SAL.

Dose substantiation (Method VD): Specific procedures to substantiate that a preselected dose (25 kGy or 15 kGy) achieves SAL 10−6 for a product or product family.

Bioburden and microbiological testing: Requirements for sampling, determination of product bioburden, and interpretation of sterility test results used in dose calculations.

Sampling and product representation: Definitions and guidance on Sample Item Portions (SIP), selection of representative products, and designation of items that represent a product family for verification experiments.

Verification dose experiments: Protocols for performing incremental irradiation and sterility testing at sub‑sterilizing doses to extrapolate required sterilization dose.

Sterilization dose audit: Procedures to routinely audit and confirm that the established dose continues to achieve the required SAL; defines actions on audit failure.

Product families: Criteria for defining, maintaining and updating product families so that dose setting and audits apply consistently across similar products.

Applications and users

Medical device manufacturers validating radiation sterilization processes

Sterilization process engineers and validation specialists

Quality assurance and regulatory affairs teams preparing validation dossiers

Contract sterilization providers conducting dose setting and routine audits

Test laboratories performing bioburden and sterility testing

Practical uses include selecting an appropriate sterilization dose, substantiating use of standard doses (25 kGy/15 kGy), designing verification studies, and establishing ongoing audit programs that support regulatory compliance and product safety.

Related standards

ISO 11137-1: Requirements for development, validation and routine control of a sterilization process

ISO 11737-1: Determination of a population of microorganisms on products

ISO 11737-2: Sterility tests used in sterilization validation

Keywords: ISO 11137-2, sterilization dose, radiation sterilization, 25 kGy, 15 kGy, SAL 10^-6, bioburden, dose audit, product family, medical device sterilization.

ISO 11137-2:2013

Abstract

Похожие стандарты

Overview

Key topics and requirements

Applications and users

Related standards

Технические детали

BS EN ISO 11137-1:2026

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ISO 11737-2:2019

Sterilization of health care products — Microbiological methods — Part 2: Tests of sterility performed in the…