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Standard

SN EN ISO 11737-1:2018

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ISO 11737-1:2018 specifies requirements and provides guidance on the enumeration and microbial characterization of the population of viable microorganisms on or in a health care product, component, raw material or package. NOTE 1 The nature and extent of microbial characterization is dependent on the intended use of bioburden data. NOTE 2 See Annex A for guidance on Clauses 1 to 9. ISO 11737-1:2018 does not apply to the enumeration or identification of viral, prion or protozoan contaminants. This includes the removal and detection of the causative agents of spongiform encephalopathies, such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. NOTE 3 Guidance on inactivating viruses and prions can be found in ISO 22442-3, ICH Q5A(R1) and ISO 13022. ISO 11737-1:2018 does not apply to the microbiological monitoring of the environment in which health care products are manufactured.

Specifiche dei prodotti

  • Standard da INB
  • Pubblicato:
  • Efficace:
  • Edizione: 3
  • Tipo di documento: EN
  • Pagine
  • ICS 11.080.01
  • ICS 07.100.10
  • Publisher SNV
  • Distributor SNV
  • National Committee INB/NK 171
  • European TC CEN/TC 204
  • International TC ISO/TC 198

Riferimento legale

Autorità federale svizzera: SWISSMEDIC
Designato ai sensi della legge svizzera:
Riferimento legaleRestrizioni
812.213
Designato ai sensi della legislazione dell'UE:
Riferimento legaleRestrizioni
Regulation (EU) 2017/745
Regulation (EU) 2017/746

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