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EN ISO 13408-1:2015 Standard

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  Keywords:

#guidance #place #part #processes #offers

  Directive

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

  Last Official Journal reference

Friday 17th of November 2017

  Description:

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

  Purpose

This part of ISO 13408 specifies the general requirements for, and offers guidance on, processes, programmes and procedures for development, validation and routine control of the manufacturing process for aseptically-processed health care products. 1.2 This part of ISO 13408 includes requirements and guidance relative to the overall topic of aseptic processing. Specific requirements and guidance on various specialized processes and methods related to filtration, lyophilization, clean-in place (CIP) technologies, sterilization in place (SIP) and isolator systems are given in other parts of ISO 13408.

  Publication

Friday 17th of November 2017

  Reference

This standard superseed the "EN ISO 13408-1:2011".

Anyway is still possible use the "EN ISO 13408-1:2011" until June 30th, 2016

  Related Standards

EN ISO 13408-6:2011

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

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

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 61326-2-6:2006

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

Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro...

EN 61010-2-101:2002

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

Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Particular requirements fo...

EN ISO 23640:2015

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

In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)

EN ISO 20776-1:2006

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

Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infectious agents and evaluation of p...

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