BS EN ISO 13408-5:2011 - Aseptic processing of health care products. Sterilization in place

BS EN ISO 13408-5:2011

Aseptic processing of health care products. Sterilization in place

Status : Current, Under review   Published : October 2011
Conformity to regulation : Designated



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.

Standard NumberBS EN ISO 13408-5:2011
TitleAseptic processing of health care products. Sterilization in place
StatusCurrent, Under review
Publication Date31 October 2011
Conformity to regulationDesignated
Normative References(Required to achieve compliance to this standard)ISO 14161, ISO 9001:2000, ISO 13408-1, ISO 11138, ISO 14937, ISO 11140, ISO/IEC 90003, ISO 13408-4, ISO 17665-1
Informative References(Provided for Information)ISO 13408, 93/42/EEC, ISO 22442, 98/79/EC, ISO 9000, ISO/TS 11139:2006, 90/385/EEC
ReplacesBS EN 13824:2004
International RelationshipsEN ISO 13408-5:2011
DescriptorsQuality assurance systems, Medical equipment, Sterile equipment, Personnel, Verification, Sterilizers, Environment (working), Sterilization (hygiene), Quality control, Quality management, Production
Title in FrenchTraitement aseptique des produits de santé. Stérilisation sur place
Title in GermanAseptische Herstellung von Produkten für die Gesundheitsfürsorge. Sterilisation vor Ort
ISBN978 0 580 72611 8
File Size1.021 MB

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