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EN ISO 13408-6:2011 Standard

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  Keywords:

#part #aseptic #isolator #requirements #used

  Directive

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

  Last Official Journal reference

Friday 17th of November 2017

  Description:

Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005)

  Purpose

This part of ISO 13408 specifies the requirements for isolator systems used for aseptic processing and offers guidance on qualification, bio-decontamination, validation, operation and control of isolator systems used for aseptic processing of health care products. This part of ISO 13408 is focused on the use of isolator systems to maintain aseptic conditions; this may include applications for hazardous materials. 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 in particular to national or regional jurisdictions.

  Publication

Friday 17th of November 2017

  Related Standards

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EN 13532:2002

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EN ISO 13485:2016/AC:2016

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Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

EN ISO 13485:2016

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

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

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