Standard

NS-EN ISO 13408-6:2011

Withdrawn

Note: This standard has a new edition: NS-EN ISO 13408-6:2021

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Abstract

ISO 13408-6:2005 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.ISO 13408-6:2005 is focused on the use of isolator systems to maintain aseptic conditions; this may include applications for hazardous materials.ISO 13408-6:2005 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.

Document information

  • Standard from SN
  • Published:
  • Withdrawn:
  • Edition: 2011-06
  • Version: 1
  • Document type: NAT
  • ICS 11.080.01
  • National Committee CEN/TC 204

Legal references

EU law: 93/42/EEC, 90/385/EEC, 98/79/EC

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