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Guidline

Standards [CURRENT]

DIN EN ISO 12417-1

Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements (ISO 12417-1:2024); German version EN ISO 12417-1:2024
Edition 2024-08

Standards [CURRENT]

DIN EN ISO 21676

Water quality - Determination of the dissolved fraction of selected active pharmaceutical ingredients, transformation products and other organic substances in water and treated waste water - Method using high performance liquid chromatography and mass spectrometric detection (HPLC-MS/MS or -HRMS) after direct injection (ISO 21676:2018); German version EN ISO 21676:2021
Edition 2022-01

Standards [CURRENT]

SN EN ISO 12417-1

Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements (ISO 12417-1:2024)
Edition 2024-03

Standards [CURRENT]

DIN EN ISO 11615

Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated medicinal product information (ISO 11615:2017 + Amd 1:2022); German version EN ISO 11615:2017 + A1:2022
Edition 2022-12

Standards [CURRENT]

DIN EN ISO 27953-2

Health informatics - Individual case safety reports (ICSRs) in pharmacovigilance - Part 2: Human pharmaceutical reporting requirements for ICSR (ISO 27953-2:2011); German and English version EN ISO 27953-2:2011, only on CD-ROM
Edition 2012-09

Technical Specification [available pre-publication]

DIN CEN ISO/TS 4958

Nanotechnologies - Vocabulary - Liposomes (ISO/TS 4958:2024); German version CEN ISO/TS 4958:2024
Edition 2024-12

Standards [CURRENT]

OENORM EN ISO 21676

Water quality - Determination of the dissolved fraction of selected active pharmaceutical ingredients, transformation products and other organic substances in water and treated waste water - Method using high performance liquid chromatography and mass spectrometric detection (HPLC-MS/MS or -HRMS) after direct injection (ISO 21676:2018)
Edition 2022-01-01

Standards [CURRENT]

DIN EN ISO 11608-3

Needle-based injection systems for medical use - Requirements and test methods - Part 3: Containers and integrated fluid paths (ISO 11608-3:2022, Corrected version 2023-01); German version EN ISO 11608-3:2022
Edition 2024-01

Standards [CURRENT]

DIN EN ISO 20072

Aerosol drug delivery device design verification - Requirements and test methods (ISO 20072:2009); German version EN ISO 20072:2013
Edition 2013-10

Standards [CURRENT]

SN EN ISO 21676

Water quality - Determination of the dissolved fraction of selected active pharmaceutical ingredients, transformation products and other organic substances in water and treated waste water - Method using high performance liquid chromatography and mass spectrometric detection (HPLC-MS/MS or -HRMS) after direct injection (ISO 21676:2018)
Edition 2021-08

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