Standard Svensk standard · SS-EN ISO 14161:2009

Sterilisering av medicintekniska produkter - Biologiska indikatorer - Vägledning för val, användning och tolkning av resultat (ISO 14161:2009)

Status: Upphävd · Ersätts av: SS-EN ISO 11138-7:2019

Omfattning
This International Standard 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. This International Standard applies to biological indicators for which International Standards exist.

NOTE 1 See, for example, the ISO 11138 series.

NOTE 2 The general information provided in this International Standard can have useful application for processes and biological indicators not currently addressed by existing International Standards, e.g., new and developing sterilization processes.

This International Standard does not consider those processes that rely solely on physical removal of microorganisms, e.g., filtration.

This International Standard is not intended to apply to combination processes using, for example, washer disinfectors or flushing and steaming of pipelines.

This International Standard is not intended to apply to liquid 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 - Guidance for the selection, use, and interpretation of results (ISO 14161:2009)

Artikelnummer: STD-71240

Utgåva: 2

Fastställd: 2009-09-28

Antal sidor: 80

Ersätter: SS-EN ISO 14161

Ersätts av: SS-EN ISO 11138-7:2019