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Standards [CURRENT]

DIN EN ISO 11137-3

Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control (ISO 11137-3:2017); German version EN ISO 11137-3:2017
Edition 2017-11

Technical Specification

DIN CEN ISO/TS 11137-4

Sterilization of health care products - Radiation - Part 4: Guidance on process control (ISO/TS 11137-4:2020); German version CEN ISO/TS 11137-4:2023
Edition 2023-10

Standards [CURRENT]

DIN EN ISO 11138-1

Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO 11138-1:2017); German version EN ISO 11138-1:2017
Edition 2017-07

Standards [CURRENT]

DIN EN ISO 11138-2

Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2017); German version EN ISO 11138-2:2017
Edition 2017-07

Standards [CURRENT]

DIN EN ISO 11138-3

Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2017); German version EN ISO 11138-3:2017
Edition 2017-07

Standards [CURRENT]

DIN EN ISO 11138-4

Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes (ISO 11138-4:2017); German version EN ISO 11138-4:2017
Edition 2017-07

Standards [CURRENT]

DIN EN ISO 11138-5

Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes (ISO 11138-5:2017); German version EN ISO 11138-5:2017
Edition 2017-07

Standards [CURRENT]

DIN EN ISO 11138-7

Sterilization of health care products - Biological indicators - Part 7: Guidance for the selection, use and interpretation of results (ISO 11138-7:2019); German version EN ISO 11138-7:2019
Edition 2019-11

Standards [CURRENT]

DIN EN ISO 11138-8

Sterilization of health care products - Biological indicators - Part 8: Method for validation of a reduced incubation time for a biological indicator (ISO 11138-8:2021); German version EN ISO 11138-8:2021
Edition 2021-11

Standards [CURRENT]

DIN EN ISO 11139

Sterilization of health care products - Vocabulary of terms used in sterilization and related equipment and process standards (ISO 11139:2018 + Amd 1:2024); German and English version EN ISO 11139:2018 + A1:2024
Edition 2024-06

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