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EN ISO 13408-4:2011 Standard

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  Keywords:

#part #equipment #processes #requirements #national

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 14th 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

  Reference

This standard supersedes the "EN 13824:2004"

Anyway is still possible use the "EN 13824:2004" until December 31st, 2011

  Related Standards

EN ISO 25539-2:2009

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EN ISO 8835-2:2009

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Inhalational anaesthesia systems - Part 2: Anaesthetic breathing systems (ISO 8835-2:2007)

EN ISO 5366-1:2009

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Anaesthetic and respiratory equipment - Tracheostomy tubes - Part 1: Tubes and connectors for use in adults (ISO 5366-1:2000)

EN ISO 5840:2009

Medical devices Directive (93/42/EEC)

Cardiovascular implants - Cardiac valve prostheses (ISO 5840:2005)

EN ISO 7197:2009

Medical devices Directive (93/42/EEC)

Neurosurgical implants - Sterile, single-use hydrocephalus shunts and components (ISO 7197:2006, including Cor 1:2007)

EN ISO 7396-1:2007

Medical devices Directive (93/42/EEC)

Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum (ISO 7396-1:2007)

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