NS-EN ISO 11138-7:2019

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Norwegian title: Sterilisering av helsetjenesteprodukter — Biologiske indikatorer — Del 7: Veiledning for utvelgelse, bruk og tolkning av resultater (ISO 11138-7:2019)
English title: Sterilization of health care products — Biological indicators — Part 7: Guidance for the selection, use and interpretation of results (ISO 11138-7:2019)
Item type: Standard
Language: Engelsk
Edition: 2019-04 (2019-07-01)
Supersedes: NS-EN ISO 14161:2009 Alert Withdrawn
Number of pages: 80
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Included in: NS ICS 11.080
NS ICS 11
NS ICS 11.080.01
NS og NS-EN komplett (eks NS-EN ISO)
Scope: This document provides guidance for the selection, use and interpretation of results from application of biological indicators when used in the development, validation and routine monitoring of sterilization processes. It does not consider those processes that rely solely on physical removal of microorganisms, e.g. filtration. It is not applicable to combination processes using, for example, washer-disinfectors or flushing and steaming of pipelines. It does not specify requirements for the selection and use of biological indicators intended to monitor vaporised hydrogen peroxide processes for isolator and room biodecontamination processes at atmospheric pressure. It is not applicable to liquid immersion sterilization processes.
Committee: SN/K 108
Adopted: 2019-07-01
ICS: 11.080.01 - Sterilisering og desinfeksjon. Generelt