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Administrative provision

2004/C24/03

Note for guidance on minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products (EMEA/410/01 Rev. 2 - October 2003) adopted by the Committee for Proprietary Medicinal Products (CPMP) and by the Committee for Veterinary Medicinal products (CVMP)
Edition 2004-01-28

Standards [CURRENT]

DIN ISO 13022

Medical products containing viable human cells - Application of risk management and requirements for processing practices (ISO 13022:2012)
Edition 2014-06

Standards [CURRENT]

DIN 58924

Haemostaseology - Reference method for the determination of the collagen binding acitvity of the VWF; Text in German and English
Edition 2022-05

Standards [CURRENT]

DIN EN ISO 22442-3

Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents (ISO 22442-3:2007); German version EN ISO 22442-3:2007
Edition 2008-03

Standards [CURRENT]

DIN EN 17122

Chemical disinfectants and antiseptics - Quantitative non-porous surface test for the evaluation of virucidal activity of chemical disinfectants and antiseptics used in the veterinary area - Test method and requirements - Phase 2, step 2; German version EN 17122:2019
Edition 2020-02

Standards [CURRENT]

DIN EN 16777

Chemical disinfectants and antiseptics - Quantitative non-porous surface test without mechanical action for the evaluation of virucidal activity of chemical disinfectants used in the medical area - Test method and requirements (phase 2, step 2); German version EN 16777:2018
Edition 2019-03

Standards [CURRENT]

DIN 58987

Haemostaseology - Reference method for the Von Willebrand Factor antigen; Text in German and English
Edition 2024-04

Standards [CURRENT]

DIN ISO 21882

Sterile packaged ready for filling glass vials (ISO 21882:2019)
Edition 2020-12

Standards [CURRENT]

DIN ISO 21881

Sterile packaged ready for filling glass cartridges (ISO 21881:2019)
Edition 2020-12

Standards [New]

DIN EN ISO 12417-1

Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements (ISO 12417-1:2024); German version EN ISO 12417-1:2024
Edition 2024-08

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