DIN EN ISO 13408-3:2011-09
Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006); German version EN ISO 13408-3:2011
| Fecha edición: |
2011-09-01
En Vigor
|
|---|---|
| Idiomas disponibles: | Inglés, Alemán |
| Resumen: | This part of ISO 13408 specifies requirements for, and offers guidance on, equipment, processes, programs and procedures for the control and validation of lyophilization as an aseptic process. It does not address the physical/chemical objectives of a lyophilization process. |
| Keywords: | Aseptic|CE marking|Clean rooms|Cleaning|Containers|Definitions|Freeze-drying|Guide books|Health services|Insulators|Maintenance|Medical devices|Medical equipment|Medical products|Medical sciences|Medical technology|Occupational medicine|Personnel|Processing|Public health protection|Quality assurance|Quality management|Specification (approval)|Sterile|Sterility|Sterilization (hygiene)|Surveillance (approval)|Validation |
| ICS: | 11.080.01 - Esterilización y desinfeccion en general |
| CTN: | |
|
Equivalencia Internacional |
Idéntica EN ISO 13408-3:2011 Idéntica ISO 13408-3:2006 |
|
Reemplazo Normas |
Reemplaza a DIN EN 13824:2005-02 Reemplaza a DIN EN ISO 13408-3:2011-01 |










