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SSH EN ISO 13408-5:2011

Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)

Mar 26, 2012

General information

60.60     Mar 26, 2012

DPS

DPS/KT 316

European Norm

11.080.01  

English  

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Scope

ISO 13408-5:2006 specifies the general requirements for sterilization in place (SIP) applied to product contact surfaces of the equipment used in the manufacture of sterile health care products by aseptic processing and offers guidance on qualification, validation, operation and control.
ISO 13408-5:2006 applies to processes where sterilizing agents are delivered to the internal surfaces of equipment that can come in contact with the product.

Related directives

Directives related to this standards.

98/79/EC

In vitro diagnostic medical devices

Harmonized
93/42/EEC

Medical devices

Harmonized
90/385/EEC

Active implantable medical devices

Harmonized

Life cycle

NOW

PUBLISHED
SSH EN ISO 13408-5:2011
60.60 Standard published
Mar 26, 2012

Related project

Adopted from EN ISO 13408-5:2011