Verkkokauppa
SFS-EN ISO 11138-2:2017:en
Sterilization of health care products. Biological indicators. Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2017)
Soveltamisala
Suomenkielistä soveltamisalaa ei ole saatavissa.
ISO 11138-2:2017 specifies 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 and ISO 14937.
NOTE 2 National or regional regulations can provide requirements for work place safety.
Tämän julkaisun valmistelusta Suomessa vastaa Palvelualojen työnantajat PALTA ry, puh. 040 579 4393.
ISO 11138-2:2017 specifies 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 and ISO 14937.
NOTE 2 National or regional regulations can provide requirements for work place safety.
Tämän julkaisun valmistelusta Suomessa vastaa Palvelualojen työnantajat PALTA ry, puh. 040 579 4393.
Sisällysluettelo
Tuoteryhmä(t)
Sidokset
Velvoittavat viittaukset
ISO 11138-1:2017 Sterilization of health care products -- Biological indicators -- Part 1: General requirements
ISO 18472:2006 Sterilization of health care products -- Biological and chemical indicators -- Test equipment
ISO 18472:2006 Sterilization of health care products -- Biological and chemical indicators -- Test equipment
Tekninen komitea
Vahvistuspäivä
07.04.2017
Julkaisupäivä
11.04.2017
Painos
3
Sivumäärä
13
Julkaisun kieli
englanti