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Standards [CURRENT]

DIN EN ISO 8871-3

Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 3: Determination of released-particle count (ISO 8871-3:2003 + Amd 1:2018); German version EN ISO 8871-3:2004 + A1:2019
Edition 2019-08

Draft standard [New]

DIN EN ISO 8871-5

Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing (ISO/DIS 8871-5:2024); German and English version prEN ISO 8871-5:2024
Edition 2024-05

Standards [CURRENT]

DIN EN ISO 8871-1

Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 1: Extractables in aqueous autoclavates (ISO 8871-1:2003); German version EN ISO 8871-1:2004, text in German and English
Edition 2004-11

Standards [CURRENT]

DIN EN ISO 13408-5

Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006); German version EN ISO 13408-5:2011
Edition 2011-09

Standards [CURRENT]

DIN EN 13091

Biotechnology - Performance criteria for filter elements and filtration assemblies; German version EN 13091:1999
Edition 2000-02

Standards [CURRENT]

DIN EN ISO 11239

Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging (ISO 11239:2023); German version EN ISO 11239:2023
Edition 2023-10

Standards [CURRENT]

DIN ISO 15759

Medical infusion equipment - Plastics caps with inserted elastomeric liner for containers manufactured by the blow-fill-seal (BFS) process (ISO 15759:2005)
Edition 2006-05

Standards [CURRENT]

DIN ISO 11040-3

Prefilled syringes - Part 3: Seals for dental local anaesthetic cartridges (ISO 11040-3:2012)
Edition 2014-05

Standards [available pre-publication]

DIN ISO 4802-2

Glassware - Hydrolytic resistance of the interior surfaces of glass containers - Part 2: Determination by flame spectrometry and classification (ISO 4802-2:2023)
Edition 2024-08

Standards [available pre-publication]

DIN ISO 4802-1

Glassware - Hydrolytic resistance of the interior surfaces of glass containers - Part 1: Determination by titration method and classification (ISO 4802-1:2023)
Edition 2024-08

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