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

EN 552

Sterilization of medical devices - Validation and routine control of sterilization by irradiation

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Versions

Legislation and regulations

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Current edition

NEN-EN 552:1995 en

Amendments and corrections (3)

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amendment
NEN-EN 552:1995/A2:2001 en

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amendment
NEN-EN 552:1995/Ontw. A2:2000 en

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amendment
NEN-EN 552:1995/A1:1999 en

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

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

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