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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 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 13091

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

Standards [CURRENT]

DIN EN ISO 20857

Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010); German version EN ISO 20857:2013
Edition 2013-08

Standards [CURRENT]

DIN EN 17141

Cleanrooms and associated controlled environments - Biocontamination control; German version EN 17141:2020
Edition 2021-02

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 EN ISO 13408-7

Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012); German version EN ISO 13408-7:2015
Edition 2015-11

Standards [CURRENT]

DIN EN ISO 13408-4

Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005); German version EN ISO 13408-4:2011
Edition 2011-09

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