Norm

NEN-EN-ISO 13408-1:2015 en

Aseptisch verwerken van producten in de gezondheidszorg - Deel 1: Algemene eisen

161,21

Over deze norm

Status Definitief
Aantal pagina's 53
Gepubliceerd op 01-06-2015
Taal Engels
NEN-EN-ISO 13408-1 specifies the general requirements for, and offers guidance on, processes, programmes and procedures for development, validation and routine control of the manufacturing process for aseptically-processed health care products. This part of ISO 13408 includes requirements and guidance relative to the overall topic of aseptic processing. Specific requirements and guidance on various specialized processes and methods related to filtration, lyophilization, clean-in place (CIP) technologies, sterilization in place (SIP) and isolator systems are given in other parts of ISO 13408.conditions.

Details

ICS-code 11.080.01
Nederlandse titel Aseptisch verwerken van producten in de gezondheidszorg - Deel 1: Algemene eisen
Engelse titel Aseptic processing of health care products - Part 1: General requirements
Vervangt
Normatieve verwijzingen
  • 93/42/EEG, Medische hulpmiddelen
  • 98/79/EG, In vitro diagnostica

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