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EN ISO 13408-4:2011 Standard

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  Keywords:

#part #equipment #processes #requirements #national

  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 4: Clean-in-place technologies (ISO 13408-4:2005)

  Purpose

This part of ISO 13408 specifies the general requirements for clean-in-place (CIP) processes applied to product contact surfaces of equipment used in the manufacture of sterile health care products by aseptic processing and offers guidance on qualification, validation, operation and control. This part of ISO 13408 is applicable to processes where cleaning agents are delivered to the internal surfaces of equipment designed to be compatible with CIP, which may come in contact with the product. This part of ISO 13408 is not applicable to processes where equipment is dismantled and cleaned in a washer. This part of ISO 13408 does not supersede or replace national regulatory requirements, such as Good Manufacturing Practices (GMPs) and/or compendial requirements that pertain to particular national or regional jurisdictions.

  Publication

Friday 17th of November 2017

  Related Standards

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

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instrumen...

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

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

EN 13975:2003

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Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects

EN 13641:2002

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Elimination or reduction of risk of infection related to in vitro diagnostic reagents

EN 13612:2002/AC:2002

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Performance evaluation of in vitro diagnostic medical devices

EN 13532:2002

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

General requirements for in vitro diagnostic medical devices for self-testing

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