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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

Thursday 15th of April 2021

  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 supersedes the "EN ISO 13408-1:2011"

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

  Related Standards

EN 556-2:2015

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

Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptic...

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 13408-5:2011

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

Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)

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 13641:2002

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

Elimination or reduction of risk of infection related to 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)

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