Standard Svensk standard · SS-EN ISO 11138-7:2019

Sterilisering av medicintekniska produkter - Biologiska indikatorer - Vägledning för val, användning och tolkning av resultat (ISO 11138-7:2019)

Status: Gällande

Omfattning
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.

Ämnesområden

Medicinsk utrustning allmänt (11.040.01) Sterilisering och desinficering allmänt (11.080.01) Farmakopéprodukter allmänt (11.120.01)


Produktinformation

Språk: Engelska

Framtagen av: Rengöring, desinfektion och sterilisering, SIS/TK 349

Internationell titel: Sterilization of health care products - Biological indicators - Part 7: Guidance for the selection, use and interpretation of results (ISO 11138-7:2019)

Artikelnummer: STD-80011454

Utgåva: 1

Fastställd: 2019-04-24

Antal sidor: 80

Ersätter: SS-EN ISO 14161:2009