SS-ISO-13408-7 Aseptic processing of health care products - Part 7: Alternative processes for atypical medical devices and combination products (ISO 13408-7:2012, IDT)

SS-ISO-13408-7 - 2012 EDITION - CURRENT

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This part of ISO 13408 specifes requirements and provides guidance on alternative approaches to process simulations for the qualifcation 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.

To find similar documents by classification:

11.080.01 (Sterilization and disinfection in general Including sterilization methods, air quality of surgery rooms, etc.)

11.080.20 (Disinfectants and antiseptics Chemicals for industrial and domestic disinfection purposes, see 71.100.35)

11.080.99 (Other standards related to sterilization and disinfection)

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Designation Name

SS-ISO 13408-7:2012

Revision Level




Publication Date

Dec. 6, 2012



Page Count


International Equivalent

ISO 13408-7:2012(IDT)