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EN ISO 13408-7:2015 Standard

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  Keywords:

#process #aseptic #part #simulation #cannot

  Directive

In vitro diagnostic medical devices Directive (98/79/EC)

  Last Official Journal reference

Thursday 15th of April 2021

  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 62304:2006/AC:2008

In vitro diagnostic medical devices Directive (98/79/EC)

Medical device software - Software life-cycle processesIEC 62304:2006

EN ISO 15223-1:2016

In vitro diagnostic medical devices Directive (98/79/EC)

Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requir...

EN ISO 11737-2:2009

In vitro diagnostic medical devices Directive (98/79/EC)

Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation an...

EN ISO 13408-1:2015

In vitro diagnostic medical devices Directive (98/79/EC)

Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)

EN ISO 13408-2:2011

In vitro diagnostic medical devices Directive (98/79/EC)

Aseptic processing of health care products - Part 2: Filtration (ISO 13408-2:2003)

EN ISO 13408-3:2011

In vitro diagnostic medical devices Directive (98/79/EC)

Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006)

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