EN
SR EN 13824:2005
Sterilizarea dispozitivelor medicale. Tratarea aseptică a dispozitivelor medicale lichide. Cerinţe
This document specifies requirements for the design and operation of aseptic processing facilities and the validation and routine control of aseptic processes for the preparation of sterile liquid medical devices. It is not applicable to those pharmaceutical products where the requirements of the relevant good manufacturing practices are applicable. NOTE Many of the principles included in this document can be applied to certain aseptically processed sterile solid medical devices.
Status :
Anulat
Data aprobării : 23.12.2005
Data publicării : 25.12.2005
Data anulării : 31.10.2011
Număr de pagini : 63
ICS : 11.080.01 Sterilizare si dezinfectare în general
Comitet tehnic : 377 - Medicale
- Inlocuit prin SR EN ISO 13408-2:2011
- Inlocuit prin SR EN ISO 13408-4:2011
- Inlocuit prin SR EN ISO 13408-3:2011
- Inlocuit prin SR EN ISO 13408-1:2011
- Inlocuit prin SR EN ISO 13408-6:2011
- Inlocuit prin SR EN ISO 13408-5:2011