BS EN ISO 13408-7:2015 - Aseptic processing of health care products. Alternative processes for medical devices and combination products

BS EN ISO 13408-7:2015

Aseptic processing of health care products. Alternative processes for medical devices and combination products

Status : Current, Under review   Published : February 2013

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ISO 13408-7:2012 specifies requirements and provides guidance on alternative approaches to process simulations for the qualification of the aseptic processing of medical devices and combination products that cannot be terminally sterilized and where the process simulation approach according to ISO 13408-1 cannot be applied. ISO 13408-7:2012 describes how risk assessment can be used during the development of an aseptic process to design a process simulation study for medical devices and combination products in those cases where a straightforward substitution of media for product during aseptic processing is not feasible or would not simulate the actual aseptic process.




Standard NumberBS EN ISO 13408-7:2015
TitleAseptic processing of health care products. Alternative processes for medical devices and combination products
StatusCurrent, Under review
Publication Date28 February 2013
Normative References(Required to achieve compliance to this standard)ISO 13408-1:2008
Informative References(Provided for Information)ISO 14698, PDA Technical Report 22 (TR22), 90/385/EEC, SG3/N15R8/2005, SG3/N99-10, European Pharmacopoeia, ISO 11137-2, ISO 13485, EU Good Manufacturing Practice Directive, JP Pharmacopoeia, EMEA/CHMP/410869/2006, ICH Guidance for Industry — Q9 Quality Risk Management, ISO 14644, 2005/17/EC, US Pharmacopoeia, ISO 14971:2007, PDA Technical Report 44 (TR44), PDA Technical Report 34 (TR34), 2004/23/EC, ISO 11737-2
International RelationshipsEN ISO 13408-7 (ISO 13408-7:20
Amended ByCorrigendum, August 2015
DescriptorsContainers, Quality assurance systems, Production, Quality management, Verification, Clean rooms, Sterile equipment, Sterilization (hygiene), Environment (working), Medical equipment, Quality control, Personnel
ICS11.080.01
Title in FrenchTraitement aseptique des produits de santé. Procédés alternatifs pour les dispositifs médicaux et les produits de combinaison
Title in GermanAseptische Herstellung von Produkten für die Gesundheitsfürsorge. Alternative Verfahren für Medizinprodukte und Kombinationsprodukte
CommitteeCH/198
ISBN978 0 580 84747 9
PublisherBSI
FormatA4
DeliveryYes
Pages32
File Size1.354 MB
Price£182.00


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