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Standards [CURRENT]

DIN 58950-6

Sterilization - Steam sterilizers for pharmaceutical products - Part 6: Operation; Text in German and English
Edition 2019-03

Standards [CURRENT]

DIN EN ISO 10993-11

Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017); German version EN ISO 10993-11:2018
Edition 2018-09

Standards [CURRENT]

DIN EN ISO 29701

Nanotechnologies - Endotoxin test on nanomaterial samples for in vitro systems - Limulus amebocyte lysate (LAL) test (ISO 29701:2010); German version EN ISO 29701:2010
Edition 2011-01

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 EN ISO 14644-17

Cleanrooms and associated controlled environments - Part 17: Particle deposition rate applications (ISO 14644-17:2021); German version EN ISO 14644-17:2021
Edition 2021-06

Standards [CURRENT]

DIN EN ISO 14644-4

Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up (ISO 14644-4:2022); German version EN ISO 14644-4:2022
Edition 2023-04

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 80369-7

Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications (ISO 80369-7:2021); German version EN ISO 80369-7:2021
Edition 2021-08

Standards [CURRENT]

DIN EN ISO 11737-2

Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019); German version EN ISO 11737-2:2020
Edition 2020-07

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

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