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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

EN ISO 81060-1:2012

Medical devices Directive (93/42/EEC)

Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type (ISO 81060-1:2007)

EN 60627:2001/AC:2002

Medical devices Directive (93/42/EEC)

Diagnostic X-ray imaging equipment - Characteristics of general purpose and mammographic anti-scatter gridsIEC 60627:2001

EN 62304:2006

Medical devices Directive (93/42/EEC)

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

EN 62220-1-3:2008

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-3: Determination of the detective quantum...

EN 62220-1-2:2007

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-2: Determination of the detective quantum...

EN 62220-1:2004

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1: Determination of the detective quantum e...

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