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DIN EN ISO 13408-4:2011-09

Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005); German version EN ISO 13408-4:2011

Fecha edición: 2011-09-01
En Vigor
Idiomas disponibles: Inglés, Alemán
Resumen: This part of ISO 13408 specifies the general requirements for clean in place (CIP) processes applied to product contact surfaces of equipment used in the manufacture of sterile health care products by aseptic processing and offers guidance on qualification, validation, operation and control.This part of ISO 13408 is applicable to processes where cleaning agents are delivered to the internal surfaces of equipment designed to be compatible with CIP, which may come in contact with the product.This part of ISO 13408 is not applicable to processes where equipment is dismantled and cleaned in a washer.This part of ISO 13408 does not supersede or replace national regulatory requirements, such as Good Manufacturing Practices (GMPs) and/or compendial requirements that pertain to particular national or regional jurisdictions.

Keywords: Aseptic|CE marking|Cleaning|Definitions|Health services|Medical technology|Public health protection|Quality assurance|Specification (approval)|Sterility|Validation
ICS: 11.080.01 - Esterilización y desinfeccion en general
CTN:

Equivalencia Internacional

Idéntica EN ISO 13408-4:2011

Idéntica ISO 13408-4:2005

Reemplazo Normas

Reemplaza a DIN EN 13824:2005-02

Reemplaza a DIN EN ISO 13408-4:2011-01

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