Overview

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. The International Standard has been prepared by Technical Committee ISO/TC 198 "Sterilization of health care products" (secretariat: ANSI, USA), with the participation of German experts and adopted by Technical Committee CEN/TC 204 "Sterilization of medical devices" (secretariat: BSI, United Kingdom) without amendment. The responsible German committee is Working Committee NA 063-01-07 AA "Aseptische Herstellung" ("Aseptic processing") at DIN Standards Committee Medicine (NAMed).

Document: references other documents

Document: referenced in other documents

Responsible national committee

NA 176-03-10 AA - Aseptic processing  

Responsible european committee

CEN/TC 204 - Sterilization of medical devices  

Responsible international committee

ISO/TC 198/WG 9 - Aseptic processing