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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/DIS 11137-1:2023)
Edition 2023-05-15

Biological evaluation of medical devices - Part 7: ethylene oxide sterilization residuals - Amendment 1 : applicability of allowable limits for neonates and infants
Edition 2022-01-12

Packaging for terminally sterilized medical devices - Part 8: re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods
Edition 2018-12-19

Packaging for terminally sterilized medical devices - Part 7: adhesive coated paper for low temperature sterilization processes - Requirements and test methods
Edition 2017-03-15

Standards [CURRENT]

OENORM EN ISO 17665-1

Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006)
Edition 2006-11-01

Standards [CURRENT]

OENORM EN ISO 25424

Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2018 + Amd 1:2022) (consolidated version)
Edition 2022-10-01

Standards [CURRENT]

OENORM EN ISO 11135

Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014 + Amd 1:2018) (consolidated version)
Edition 2020-04-01

Standards [CURRENT]

OENORM EN ISO 11737-2

Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019)
Edition 2020-06-15

Standards [CURRENT]

SN EN ISO 10993-7/AC

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008/Cor 1:2009); Corrigendum AC
Edition 2009-11

Standards [CURRENT]

SN EN 868-8

Packaging for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods
Edition 2019-08

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