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EN iSO 13485 ISO EN 980

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Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2009) Symbols for use in the labelling of medical devices Sterilization of medical devices - Requirements for medical devices to be designated ‘STERILE’ - Part 2: Requirements for aseptically processed medical devices Sterilization of medical devices - Requirements for medical devices to be designated ‘STERILE’ - Part 1: Requirements for terminally sterilized medical devices

Reference and title of the harmonised standardĭate of cessation of presumption of conformity of superseded standard

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(Publication of titles and references of harmonised standards under the directive) Commission communication in the framework of the implementation of the Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices

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