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Displaying 1-12 of 27 results.
LVS EN 556-1:2024
standard
EN
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
11.35 €
LVS EN 556-2:2016
standard
EN
Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptically processed medical devices
12.15 €
LVS EN ISO 11135:2014
standard
EN
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)
25.88 €
LVS EN ISO 11135:2014/A1:2020
amendment
EN
Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices - Amendment 1: Revision of Annex E, Single batch release (ISO 11135:2014/Amd 1:2018)
14.26 €
LVS CEN ISO/TS 11137-4:2023
technical specification (TS)
EN
Sterilization of health care products - Radiation - Part 4: Guidance on process control (ISO/TS 11137-4:2020)
22.71 €
LVS EN ISO 11137-1:2015
standard
EN
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, including Amd 1:2013)
21.39 €
LVS EN ISO 11137-1:2015/A2:2020
amendment
EN
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 11137-1:2006/Amd 2:2018)
12.93 €
LVS EN ISO 11137-2:2015
standard
EN
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)
25.88 €
LVS EN ISO 11137-2:2015/A1:2023
amendment
EN
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose - Amendment 1 (ISO 11137-2:2013/Amd 1:2022)
10.56 €
LVS EN ISO 11137-3:2017
standard
EN
Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control (ISO 11137-3:2017)
20.33 €
LVS EN ISO 11737-1:2018
standard
EN
Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018)
21.39 €
LVS EN ISO 11737-1:2018/A1:2021
amendment
EN
Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products - Amendment 1 (ISO 11737-1:2018/Amd 1:2021)
10.56 €