11.080.01 : Sterilization and disinfection in general

PNE-prEN ISO 11737-3

PNE-prEN ISO 11737-3

Withdrawn Most Recent

Sterilization of health care products - Microbiological methods - Part 3: Bacterial endotoxin testing (ISO 11737-3:2023)

€113.00

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ISO 14937:2009/WD Amd 1:2026

ISO 14937:2009/WD Amd 1:2026

Forthcoming Most Recent

Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices Amendment 1

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ISO 17665:2024/AWI Amd 1:2025

ISO 17665:2024/AWI Amd 1:2025

Forthcoming Most Recent

Sterilization of health care products — Moist heat — Requirements for the development, validation and routine control of a sterilization process for medical devices

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ISO 11140-1:2014/AWI Amd 1:2025

ISO 11140-1:2014/AWI Amd 1:2025

Forthcoming Most Recent

Sterilization of health care products — Chemical indicators — Part 1: General requirements

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ISO/CD 11140-3:2024

ISO/CD 11140-3:2024

Withdrawn Most Recent

Sterilization of health care products — Chemical indicators

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ISO/CD 11140-4:2024

ISO/CD 11140-4:2024

Withdrawn Most Recent

Sterilization of health care products — Chemical indicators

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ISO/CD 11140-5:2024

ISO/CD 11140-5:2024

Withdrawn Most Recent

Sterilization of health care products — Chemical indicators

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ISO/DIS 11135:2024

ISO/DIS 11135:2024

Withdrawn Most Recent

Sterilization of health care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices

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DIN EN ISO 11135:2024-04

DIN EN ISO 11135:2024-04

Superseded Historical

Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11135.2:2024); German and English version prEN ISO 11135:2024

€229.44

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DIN EN ISO 17664-2:2023-09

DIN EN ISO 17664-2:2023-09

Superseded Historical

Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices (ISO 17664-2:2021); German and English version prEN ISO 17664-2:2023

€116.64

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DIN EN ISO 11135:2023-05

DIN EN ISO 11135:2023-05

Superseded Historical

Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11135:2023); German and English version prEN ISO 11135:2023

€248.22

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DIN EN ISO 13004:2023-03

DIN EN ISO 13004:2023-03

Superseded Historical

Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VD (ISO 13004:2022); German and English version prEN ISO 13004:2023

€167.66

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DIN EN ISO 11139/A1:2023-03

DIN EN ISO 11139/A1:2023-03

Superseded Historical

Sterilization of health care products - Vocabulary of terms used in sterilization and related equipment and process standards - Amendment 1 (ISO 11139:2018/DAM 1:2023); German and English version EN ISO 11139:2018/prA1:2023

€69.91

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DIN EN 556-1:2023-02

DIN EN 556-1:2023-02

Superseded Historical

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices; German and English version prEN 556-1:2023

€69.91

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DIN EN 556-2:2023-02

DIN EN 556-2:2023-02

Superseded Historical

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: requirements for aseptically processed medical devices; German and English version prEN 556-2:2023

€84.58

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