BS EN 13824:2004
Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
- Standard No.
- BS EN 13824:2004
- Release Date
- 2004
- Published By
- British Standards Institution (BSI)
- Status
- 2011-10
- Replace By
- BS EN ISO 13408-1:2011
- BS EN ISO 13408-1:2011+A1:2013
- BS EN ISO 13408-2:2011
- BS EN ISO 13408-3:2011
- BS EN ISO 13408-4:2011
- BS EN ISO 13408-5:2011
- BS EN ISO 13408-6:2011
- BS EN ISO 13408-6:2011+A1:2013
- Latest
- BS EN ISO 13408-1:2011+A1:2013
- BS EN ISO 13408-2:2018
- BS EN ISO 13408-3:2011
- BS EN ISO 13408-4:2011
- BS EN ISO 13408-5:2011
- BS EN ISO 13408-6:2011+A1:2013
- Scope
- 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.
BS EN 13824:2004 history
- 2011 BS EN ISO 13408-1:2011+A1:2013 Aseptic processing of health care products. General requirements
- 0000 BS EN ISO 13408-1:2011
- 2004 BS EN 13824:2004 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
