11.080.01 : Sterilization and disinfection in general

ASTM F3127-22

ASTM F3127-22

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Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices

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ASTM F3438-21

ASTM F3438-21

Superseded Historical

Standard Guide for Detection and Quantification of Cleaning Markers (Analytes) for the Validation of Cleaning Methods for Reusable Medical Devices

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ASTM E1173-23

ASTM E1173-23

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Standard Practice for Evaluation of Preoperative, Precatheterization, or Preinjection Skin Preparations

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ASTM F3208-20

ASTM F3208-20

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Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices

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BS EN ISO 11139:2018+A1:2024

BS EN ISO 11139:2018+A1:2024

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Sterilization of health care products. Vocabulary of terms used in sterilization and related equipment and process standards

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BS EN ISO 17664-1:2021

BS EN ISO 17664-1:2021

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Processing of health care products. Information to be provided by the medical device manufacturer for processing devices Critical and semi-critical

€316.00

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BS EN ISO 11137-2:2015+A1:2023

BS EN ISO 11137-2:2015+A1:2023

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Sterilization of health care products. Radiation Establishing the sterilization dose

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BS EN ISO 25424:2019+A1:2022

BS EN ISO 25424:2019+A1:2022

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Sterilization of health care products. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices

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BS ISO 18362:2016+A1:2022

BS ISO 18362:2016+A1:2022

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Manufacture of cell-based health care products. Control of microbial risks during processing

€316.00

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BS EN ISO 17665:2024

BS EN ISO 17665:2024

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

€364.00

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BS ISO 22441:2022

BS ISO 22441:2022

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Sterilization of health care products. Low temperature vaporized hydrogen peroxide. Requirements for the development, validation and routine control of a sterilization process for medical devices

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BS EN ISO 13004:2023

BS EN ISO 13004:2023

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Sterilization of health care products. Radiation. Substantiation of selected sterilization dose. Method VDmaxSD

€374.00

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BS EN ISO 17664-2:2023

BS EN ISO 17664-2:2023

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Processing of health care products. Information to be provided by the medical device manufacturer for processing devices Non-critical

€316.00

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BS EN ISO 17665:2024 ExComm

BS EN ISO 17665:2024 ExComm

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Expert Commentary for [BS EN ISO 17665:2024] Sterilization of health care products. Moist heat. Requirements for the development, validation and routine control of a sterilization process for medical devices

€104.00

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BS ISO 11737-3:2023

BS ISO 11737-3:2023

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Sterilization of health care products. Microbiological methods Bacterial endotoxin testing

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