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Standards [CURRENT]

DIN EN ISO 80369-6

Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications (ISO 80369-6:2016, Corrected version 2016-11-15); German version EN ISO 80369-6:2016
Edition 2018-10

Standards [available pre-publication]

DIN EN ISO 81060-2

Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type (ISO 81060-2:2018 + Amd.1:2020 + Amd.2:2024); German version EN ISO 81060-2:2019 + A1:2020 + A2:2024
Edition 2024-08

Standards [CURRENT]

DIN 58950-7

Sterilization - Steam sterilizers for pharmaceutical products - Part 7: Requirements on services and local environment; Text in German and English
Edition 2022-06

Standards [CURRENT]

DIN ISO 11040-4

Prefilled syringes - Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling (ISO 11040-4:2015)
Edition 2017-07

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 15197

In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013); German version EN ISO 15197:2015
Edition 2015-12

Standards [CURRENT]

DIN EN ISO 13408-1

Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013); German version EN ISO 13408-1:2015
Edition 2015-12

Standards [CURRENT]

DIN EN ISO 16140-2

Microbiology of the food chain - Method validation - Part 2: Protocol for the validation of alternative (proprietary) methods against a reference method (ISO 16140-2:2016); German version EN ISO 16140-2:2016
Edition 2016-11

Draft standard [New]

DIN EN ISO 10993-7

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO/DIS 10993-7:2024); German and English version prEN ISO 10993-7:2024
Edition 2024-08

Standards [CURRENT]

DIN EN ISO 7218

Microbiology of food and animal feeding stuffs - General requirements and guidance for microbiological examinations (ISO 7218:2007 + Amd 1:2013); German version EN ISO 7218:2007 + A1:2013
Edition 2014-09

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