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EN ISO 13408-1:2015 Standard

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  Keywords:

#guidance #place #part #processes #offers

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 14th 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

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EN ISO 17510-1:2009

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Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates

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