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This Free of Charge application was designed to help manufacturers, consultants, notified bodies to keep under control the EU declaration of conformity
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EN ISO 11737-2:2009 Standard
Keywords:
EN ISO 11737-2:2020
EN ISO 11737-2:2020
Directive
Last Official Journal reference
Description:
Purpose
Publication
In vitro diagnostic medical devices Directive (98/79/EC)
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)
In vitro diagnostic medical devices Directive (98/79/EC)
Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, vali...
In vitro diagnostic medical devices Directive (98/79/EC)
Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and rout...
In vitro diagnostic medical devices Directive (98/79/EC)
Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a steri...
In vitro diagnostic medical devices Directive (98/79/EC)
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging sy...
In vitro diagnostic medical devices Directive (98/79/EC)
Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validati...
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