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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 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 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 58950-6

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

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 10993-7

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008 + Cor 1:2009 + Amd 1:2019); German version EN ISO 10993-7:2008 + AC:2009 + A1:2022
Edition 2022-09

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 ISO 20695

Enteral feeding systems - Design and testing (ISO 20695:2020); German version EN ISO 20695:2020
Edition 2020-10

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 3826-4

Plastics collapsible containers for human blood and blood components - Part 4: Apheresis blood bag systems with integrated features (ISO 3826-4:2015); German version EN ISO 3826-4:2015
Edition 2015-12

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