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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 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 18113-4:2011

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

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents ...

EN ISO 14971:2012

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

Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)

EN ISO 15194:2009

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

In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified refer...

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 17511:2003

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

In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assign...

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