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  • BSI
    BS EN ISO 13408-7:2015 Aseptic processing of health care products - Alternative processes for medical devices and combination products
    Edition: 2015
    $435.35
    / user per year

Description of BS EN ISO 13408-7:2015 2015

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
StatusUnder Review
Publication Date2015-08-31
Identical National Standard OfEN ISO 13408-7:2015, ISO 13408-7:2012
CorrectsBS ISO 13408-7:2012
DescriptorsContainers, Quality assurance systems, Production, Quality management, Verification, Clean rooms, Sterile equipment, Sterilization (hygiene), Environment (working), Medical equipment, Quality control, Personnel
ICS11.080.01 Sterilization and disinfection in general
CommitteeCH/198
ISBN978 0 580 84747 9
PublisherBSI
Pages32

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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