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Note: This standard is partly replaced. The replacing standards are listed at the bottom of this page.See

ISO 11137

Sterilization of health care products - Requirements for validation and routine control - Radiation sterilization

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Versions

Legislation and regulations

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Current edition

ISO 11137:1995 en

Amendments and corrections (2)

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amendment
ISO 11137:1995/Amd 1:2001 en

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correction
ISO 11137:1995/Cor 1:1997 en

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This standard has been partly replaced by the following standard(s):

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

ISO 11137-1 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 2: Revision to 4.3.4 and 11.2

ISO 11137-3 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control