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Homepage>CSN Standards>85 HEALTH SERVICE>8552 General regulations and directions for articles for health service>CSN EN ISO 13408-7 - Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products
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Released: 01.02.2016
CSN EN ISO 13408-7 - Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products

CSN EN ISO 13408-7

Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products

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Number of Standard:CSN EN ISO 13408-7
Category:855264
Pages:36
Released:01.02.2016
Catalog number:98850
DESCRIPTION

CSN EN ISO 13408-7

CSN EN ISO 13408-7 This part of ISO 13408 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. This part of ISO 13408 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.
Original English text of CSN EN Standard.
The price of the Standard included all amendments and correcturs.