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SRPS ISO 13408-5:2010

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

Apr 26, 2010

General information

60.60    

ISS

Z076

European Norm

11.080.01  

English  

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Published

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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

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.

93/42/EEC

Medical devices

Harmonized
Directive 93/42/EEC
90/385/EEC

Active implantable medical devices

Harmonized
Directive 90/385/EEC
98/79/EC

In vitro diagnostic medical devices

Harmonized
Directive 98/79/EC

Life cycle

NOW

PUBLISHED
SRPS ISO 13408-5:2010
60.60 Standard published

Related project

Adopted from EN ISO 13408-5:2011

Adopted from ISO 13408-5:2006