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.
Document identifier
ISO 13408-7:2012
Title
Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products
ISO Category
TC 198: Sterilization of health care products
Publication date
2012-08-01
International Relationship
AAMI/ISO 13408-7:2012/(R)2018 * DIN EN ISO 13408-7 * BS ISO 13408-7:2012 * BS EN ISO 13408-7:2015
| Price |
138 vnd |
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