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

SS-EN-ISO-13408-7 - 2015 EDITION - CURRENT


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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.

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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)

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Active implantable medical devices. Medical devices. In vitro diagnostic medical devices

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Designation Name

SS-EN ISO 13408-7:2015

Revision Level

2015 EDITION

Status

Current

Publication Date

Aug. 9, 2015

Language(s)

English

Page Count

36

International Equivalent

EN ISO 13408-7:2015(IDT); ISO 13408-7:2012(IDT)