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  • Abstract:
    This part of ISO 11138 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.
  • Document number:
    DIN EN ISO 11138-2
  • Issuing date:
    2017-07-01
  • Document type:
    Norm
  • Title:
    Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2017); German version EN ISO 11138-2:2017
  • Replaces:
    DIN EN ISO 11138-2(2009-09); DIN EN ISO 11138-2(2015-10)
  • Author:
    DIN Standards Committee Health Technologies
  • Search term:
    Bacterial count; Bioassay; Biochemicals; Bio-indicators; Biological hazards; Biological systems; Biological tests; CE marking; Efficiency; Ethylene oxide; Evaluations; Gas sterilizers; Gases; Germ carrier; Germs; Indicators; Medical devices; Medical equipment; Medical products; Medical sciences; Methods; Microbiological analysis; Microorganisms; Performance; Population; Rating tests; Resistance; Sequence of operations; Specification; Specification (approval); Sterilization (hygiene); Sterilizers; Sterilizing apparatus; Sterilizing gases; Survival characteristics; Systems; Test germs; Test organisms; Testing; Use
  • Application areas:
    09.01 Medizinprodukte im Allgemeinen
  • Hazards:
    AC Mess- und Prüfverfahren für die Ermittlung von Belastungen und Gefährdungen; BA Biologische Gefährdungen im Allgemeinen
  • ICS:
    11.080.20 Disinfectants and antiseptics
  • Price:
    82,20 EUR
  • Cross references:
    ISO 11138-1 (2017-03)<S>; ISO 18472 (2018-08)<G>; DIN EN ISO 14937 (2010-03); ISO 11135 (2014-07); ISO 14937 (2009-10); DIN EN ISO 11135 (2020-04); DIN EN ISO 11138-1 (2017-07); DIN EN ISO 11138-7 (2019-11); DIN EN ISO 18472 (2018-11); ISO 11138-7 (2019-03)
  • Cited in:
    DIN EN ISO 10651-5 (2021-11); DIN EN ISO 11138-7 (2019-11); DIN EN ISO 11138-8 (2021-11); DIN EN ISO 11140-6 (2023-02); DIN EN ISO 11737-1 (2018-07); DIN EN ISO 11737-1 (2018-11); DIN EN ISO 11737-1 (2021-10); DIN EN ISO 11737-2 (2020-07); DIN EN ISO 18472 (2018-11); DIN ISO 11040-7 (2020-11); DIN ISO 21881 (2020-12); DIN ISO 21882 (2020-12); DGUV Information 213-086 (2019-12)
  • Identical with:
    EN ISO 11138-2(2017-03)<IDT>; ISO 11138-2(2017-03)<IDT>
  • Update flag:
    Unchanged

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