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Technical Specification

DIN CEN/TS 17390-1

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood - Part 1: Isolated RNA; German version CEN/TS 17390-1:2020
Edition 2020-05

Technical Specification

DIN CEN/TS 17390-2

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood - Part 2: Isolated DNA; German version CEN/TS 17390-2:2020
Edition 2020-05

Standards [available pre-publication]

DIN EN ISO 17665

Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665:2024); German version EN ISO 17665:2024
Edition 2024-09

Technical Specification

DIN CEN ISO/TS 23758

Guidelines for the validation of qualitative screening methods for the detection of residues of veterinary drugs in milk and milk products (ISO/TS 23758:2021); German version CEN ISO/TS 23758:2021
Edition 2022-02

Technical Specification [CURRENT]

DIN CEN ISO/TS 19256 ; DIN SPEC 13236:2017-06

Health informatics - Requirements for medicinal product dictionary systems for health care (ISO/TS 19256:2016); English version CEN ISO/TS 19256:2017
Edition 2017-06

Technical Specification [CURRENT]

DIN CEN ISO/TS 20443 ; DIN SPEC 13263:2018-11

Health informatics - Identification of medicinal products - Implementation guidelines for ISO 11615 data elements and structures for the unique identification and exchange of regulated medicinal product information (ISO/TS 20443:2017); English version CEN ISO/TS 20443:2018
Edition 2018-11

Technical rule [CURRENT]

VDI 5710 Blatt 1

Licensing and implementing of new nanotechnologies in the area of medical technology - Fundamentals
Edition 2019-07

Technical rule [CURRENT]

VDI 6305

Technical good manufacturing practice - Application guideline for projects in the GMP environment
Edition 2018-06

Managementsysteme, Nahrungsmittelmaschinen
Edition 2018-12

Praxisleitfaden zur DIN EN ISO 13485 und den neuen EU-Verordnungen
Edition 2019-04

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