NEN-EN 13824
Sterilization of medical devices - Validation and routine control of aseptic processes - Requirements and guidance
inactive
| Organization: | NEN |
| Publication Date: | 1 February 2000 |
| Status: | inactive |
| Page Count: | 76 |
| ICS Code (Sterilization and disinfection in general): | 11.080.01 |
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.
Document History
December 1, 2004
Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
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...
November 1, 2002
Sterilization of medical devices - Validation and routine control of aseptic processes - Requirements and guidance
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...
NEN-EN 13824
February 1, 2000
Sterilization of medical devices - Validation and routine control of aseptic processes - Requirements and guidance
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...