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Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007)
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Sterilization of health care products - Ethylene oxide - Part 2: Guidance on the application of ISO 11135-1 (ISO/TS 11135-2:2008)
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EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMOFILTERS AND HAEMOCONCENTRATORS.
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Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006) (Endorsed by AENOR in October of 2006.)
Available languages: English
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Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006)
Available languages: English, Spanish
Available design: electronic design (pdf), Print design
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2006) (Endorsed by AENOR in October of 2006.)
Available languages: English
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Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2006, corrected version 2006-08-01)
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Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2012)
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Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)
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Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects (ISO 11137-3:2006) (Endorsed by AENOR in October of 2006.)
Available languages: English
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