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DIN EN ISO 15193
In vitro diagnostic medical devices - Requirements for reference measurement procedures (ISO/DIS 15193:2023); German and English version prEN ISO 15193:2023
Edition
2024-02
DIN EN ISO 15883-5
Washer-disinfectors - Part 5: Performance requirements and test method criteria for demonstrating cleaning efficacy (ISO 15883-5:2021); German version EN ISO 15883-5:2021
Edition
2021-11
DIN EN ISO 11073-10101
Health informatics - Device interoperability - Part 10101: Point-of-care medical device communication - Nomenclature (ISO/IEEE 11073-10101:2020); English version EN ISO 11073-10101:2020, only on CD-ROM
Edition
2021-01
DIN EN ISO 17511
In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples (ISO 17511:2020); German version EN ISO 17511:2021
Edition
2021-11
DIN EN ISO 20916
In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice (ISO 20916:2019); German version EN ISO 20916:2024
Edition
2024-07
DIN/TR 13284
Thrombin generation assay; Text in German and English
Edition
2024-06
DIN CEN ISO/TS 19807-2
Nanotechnologies - Magnetic nanomaterials - Part 2: Specification of characteristics and measurement methods for nanostructured magnetic beads for nucleic acid extraction (ISO/TS 19807-2:2021); German version CEN ISO/TS 19807-2:2023
Edition
2023-09
DIN CEN ISO/TS 19844 ; DIN SPEC 13261:2017-12
Health informatics - Identification of medicinal products - Implementation guidelines for data elements and structures for the unique identification and exchange of regulated information on substances (ISO/TS 19844:2016); English version CEN ISO/TS 19844:2017, only on CD-ROM
Edition
2017-12
DIN EN ISO/IEEE 11073-10206
Health informatics - Device interoperability - Part 10206: Personal health device communication - Abstract content information model (ISO/IEEE FDIS 11073-10206:2024); English version prEN ISO/IEEE 11073-10206:2024
Edition
2024-04
DIN CEN ISO/TS 5798
In vitro diagnostic test systems - Requirements and recommendations for detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by nucleic acid amplification methods (ISO/TS 5798:2022); German version CEN ISO/TS 5798:2022
Edition
2023-03