Norm

NEN-EN-ISO 13408-6:2011 en

Aseptische verwerking van producten in de gezondheidszorg - Deel 6: Isolatiesystemen

Volledig inclusief:

79,70

Over deze norm

Status Definitief
Aantal pagina's 17
Gepubliceerd op 01-09-2011
Taal Engels
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.

Details

ICS-code 11.080.01
Nederlandse titel Aseptische verwerking van producten in de gezondheidszorg - Deel 6: Isolatiesystemen
Engelse titel Aseptic processing of health care products - Part 6: Isolator systems
Vervangt
Gewijzigd door
Normatieve verwijzingen
  • 93/42/EEG, Medische hulpmiddelen

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