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EN ISO 13408-7:2015 Standard

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  Keywords:

#process #aseptic #part #simulation #cannot

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 25th of March 2020

  Description:

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

  Purpose

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.

  Publication

Friday 17th of November 2017

  Related Standards

EN ISO 13408-6:2011

Medical devices Directive (93/42/EEC)

Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005)

EN ISO 10651-2:2009

Medical devices Directive (93/42/EEC)

Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 2: Home care ventilat...

EN ISO 8835-4:2009

Medical devices Directive (93/42/EEC)

Inhalational anaesthesia systems - Part 4: Anaesthetic vapour delivery devices (ISO 8835-4:2004)

EN ISO 8835-5:2009

Medical devices Directive (93/42/EEC)

Inhalational anaesthesia systems - Part 5: Anaesthetic ventilators (ISO 8835-5:2004)

EN ISO 9170-1:2008

Medical devices Directive (93/42/EEC)

Terminal units for medical gas pipeline systems - Part 1: Terminal units for use with compressed medical gases and vacuum (ISO 917...

EN ISO 9170-2:2008

Medical devices Directive (93/42/EEC)

Terminal units for medical gas pipeline systems - Part 2: Terminal units for anaesthetic gas scavenging systems (ISO 9170-2:2008)

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