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   Published : October 2011



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
Publication Date31 October 2011
Normative References(Required to achieve compliance to this standard)ISO 11138, ISO 11140, ISO 13408-1, ISO 13408-4, ISO 14161, ISO 14937, ISO 17665-1, ISO/IEC 90003, ISO 9001:2000
Informative References(Provided for Information)ISO 9000, ISO/TS 11139:2006, ISO 22442, 90/385/EEC, 93/42/EEC, 98/79/EC, ISO 13408
ReplacesBS EN 13824:2004
International RelationshipsEN ISO 13408-5:2011,ISO 13408-5:2006
DescriptorsMedical equipment, Sterile equipment, Sterilization (hygiene), Production, Environment (working), Quality assurance systems, Quality management, Quality control, Sterilizers, Verification, Personnel
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 Size1.048 MB

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