Standard Svensk standard · SS-EN ISO 11138-2:2009

Sterilisering av medicintekniska produkter - Biologiska indikatorer - Del 2: Biologiska indikatorer för steriliseringsprocesser med etylenoxid (ISO 11138-2:2006)

Status: Upphävd · Ersätts av: SS-EN ISO 11138-2:2017

Omfattning
This part of ISO 11138 provides specific requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilizers and sterilization processes employing ethylene oxide gas as the sterilizing agent, either as pure ethylene oxide gas or mixtures of this gas with diluent gases, at sterilizing temperatures within the range of 29 °C to 65 °C.

NOTE 1 Requirements for validation and control of ethylene oxide sterilization processes are provided by ISO 11135.

NOTE 2 National or regional regulations could provide requirements for work place safety.

Ämnesområden

Sterilisering och desinficering allmänt (11.080.01)


Produktinformation

Språk: Engelska

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

Internationell titel: Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2006)

Artikelnummer: STD-69753

Utgåva: 2

Fastställd: 2009-05-18

Antal sidor: 20

Ersätter: SS-EN ISO 11138-2:2006

Ersätts av: SS-EN ISO 11138-2:2017