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Draft standard

DIN EN ISO 18113-4

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO/DIS 18113-4:2021); German and English version prEN ISO 18113-4:2021
Edition 2021-09

Standards [CURRENT]

DIN EN ISO 1135-4

Transfusion equipment for medical use - Part 4: Transfusion sets for single use, gravity feed (ISO 1135-4:2015); German version EN ISO 1135-4:2015
Edition 2016-06

Standards [CURRENT]

DIN EN ISO 20186-1

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 1: Isolated cellular RNA (ISO 20186-1:2019); German version EN ISO 20186-1:2019
Edition 2019-08

Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood - Amendment 1 (ISO 10993-4:2017/DAM 1:2024); German and English version EN ISO 10993-4:2017/prA1:2024
Edition 2024-04

Technical Report Draft [New]

DIN/TR 13284

Thrombin generation assay; Text in German and English
Edition 2024-06

Standards [CURRENT]

DIN EN ISO 1135-5

Transfusion equipment for medical use - Part 5: Transfusion sets for single use with pressure infusion apparatus (ISO 1135-5:2015); German version EN ISO 1135-5:2015
Edition 2016-06

Standards [CURRENT]

DIN EN ISO 10993-16

Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017); German version EN ISO 10993-16:2017
Edition 2018-02

Standards [CURRENT]

DIN 58985

Laboratory medicine - Decision-marking criteria
Edition 2003-12

Standards [CURRENT]

DIN EN ISO 6888-1

Microbiology of the food chain - Horizontal method for the enumeration of coagulase-positive staphylococci (Staphylococcus aureus and other species) - Part 1: Method using Baird-Parker agar medium (ISO 6888-1:2021 + Amd 1:2023); German version EN ISO 6888-1:2021 + A1:2023
Edition 2024-03

Standards [CURRENT]

DIN 58932-3

Haematology - Determination of the concentration of blood corpuscles in blood - Part 3: Reference method for the determination of the concentration of erythrocytes; Text in German and English
Edition 2024-02

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