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SSH EN ISO 13408-4:2011

Trajtimi antimikrobik ndaj produkteve të kujdesit shëndetësor - Pjesa 4: Teknologjitë e vendeve të pastrimit (ISO 13408-4:2005)

Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005)
26 mar 2012

General information

60.60     26 mar 2012

DPS

DPS/KT 316

European Norm

11.080.01  

anglisht  

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Scope

ISO 13408-4:2005 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.
ISO 13408-4:2005 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.
ISO 13408-4:2005 is not applicable to processes where equipment is dismantled and cleaned in a washer.
ISO 13408-4:2005 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.

Related directives

Directives related to this standards.

98/79/EC

Pajisje mjekësore të diagnostikimit "in-vitro"

Të harmonizuara
93/42/EEC

Pajisje Mjekësore

Të harmonizuara
90/385/EEC

Pajisjet mjekësore aktive transplatuese

Të harmonizuara

Life cycle

NOW

PUBLISHED
SSH EN ISO 13408-4:2011
60.60 Standard published
26 mar 2012

Related project

Adopted from EN ISO 13408-4:2011