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Draft standard [Pre-order]

DIN EN ISO 14155

Clinical investigation of medical devices for human subjects - Good clinical practice (ISO/DIS 14155:2024); German and English version prEN ISO 14155:2024
Edition 2024-09

Standards [CURRENT]

DIN ISO 11040-6

Prefilled syringes - Part 6: Plastic barrels for injectables and sterilized subassembled syringes ready for filling (ISO 11040-6:2019)
Edition 2021-05

Standards [CURRENT]

DIN EN 16620

Food Analysis - Determination of furan in coffee and coffee products by headspace gas chromatography and mass spectrometry (HS GC-MS); German version EN 16620:2015
Edition 2015-06

Standards [CURRENT]

DIN EN ISO 10273

Microbiology of the food chain - Horizontal method for the detection of pathogenic Yersinia enterocolitica (ISO 10273:2017); German version EN ISO 10273:2017
Edition 2017-08

Draft standard

DIN EN ISO 22017

Water quality - Guidance for rapid radioactivity measurements in nuclear or radiological emergency situation (ISO/DIS 22017:2019); German and English version prEN ISO 22017:2019
Edition 2019-10

Standards [CURRENT]

DIN ISO 13022

Medical products containing viable human cells - Application of risk management and requirements for processing practices (ISO 13022:2012)
Edition 2014-06

Draft standard

DIN ISO 11040-4

Prefilled syringes - Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling (ISO/DIS 11040-4:2023); Text in German and English
Edition 2023-05

Standards [CURRENT]

DIN EN ISO 16140-3

Microbiology of the food chain - Method validation - Part 3: Protocol for the verification of reference methods and validated alternative methods in a single laboratory (ISO 16140-3:2021); German version EN ISO 16140-3:2021
Edition 2021-06

Standards [CURRENT]

DIN EN ISO 10993-1

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10); German version EN ISO 10993-1:2020
Edition 2021-05

Standards [CURRENT]

DIN EN ISO 81060-2

Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type (ISO 81060-2:2018 + Amd 1:2020); German version EN ISO 81060-2:2019 + A1:2020
Edition 2020-12

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