Standard Svensk standard · SS-EN ISO 11138-4:2017

Sterilisering av medicintekniska produkter - Biologiska indikatorer - Del 4: Biologiska indikatorer för steriliseringsprocesser med torr värme (ISO 11138-4:2017)

Status: Gällande

Omfattning
This document specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing dry heat as the sterilizing agent at sterilizing temperatures within the range of 120 °C to 180 °C.

NOTE 1 Requirements for validation and control of dry heat sterilization processes are provided by ISO 20857.

NOTE 2 Requirements for work place safety can be provided by national or regional regulations.

Ämnesområden

Sterilisering (11.080) Desinficeringsmedel och antiseptika (11.080.20)


Produktinformation

Språk: Engelska

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

Internationell titel: Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes (ISO 11138-4:2017)

Artikelnummer: STD-8025812

Utgåva: 2

Fastställd: 2017-04-05

Antal sidor: 24

Ersätter: SS-EN ISO 11138-4:2006