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Normas DIN – AENOR
DIN EN ISO 13408-4:2011-01

DIN EN ISO 13408-4:2011-01

Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005); German version FprEN ISO 13408-4:2010 / Note: Date of issue 2011-01-17

Traitement aseptique des produits de santé - Partie 4: Technologies de nettoyage sur place (ISO 13408-4:2005); Version allemande FprEN ISO 13408-4:2010 / Attention: Date de parution 2011-01-17

Aseptische Herstellung von Produkten für die Gesundheitsfürsorge - Teil 4: Reinigung vor Ort (ISO 13408-4:2005); Deutsche Fassung FprEN ISO 13408-4:2010 / Achtung: Erscheinungsdatum 2011-01-17

Fecha Anulación:
2011-09 /Withdrawn
Equivalencias internacionales:

FprEN ISO 13408-4 (2010-12)

ISO 13408-4 (2005-11)

Relación con otras normas DIN:

Reemplazada por: DIN EN ISO 13408-4:2011-09

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, Cleaning, Definitions, Health services, Medical devices, Medical technology, Public health protection, Quality assurance, Specification (approval), Sterility, Validation
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