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  • Document number:
    ISO 11138-3
  • Issuing date:
    2017-03-01
  • Document type:
    Norm
  • Title:
    Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes
  • Replaces:
    ISO 11138-3(2006-07); ISO/FDIS 11138-3(2016-10)
  • Author:
    ISO/TC 198 Sterilization of health care products
  • Search term:
    Bacterial count; Bioassay; Biochemicals; Bio-indicators; Biological analysis and testing; Biological hazards; Biological systems; Biological tests; CE marking; Damp-heat tests; Efficiency; Evaluations; Germ carrier; Germs; Heat; Heat sterilization; Indicators; Inoculation; Marking of roads; Medical devices; Medical equipment; Medical products; Medical sciences; Methods; Microbiological analysis; Microorganisms; Operation; Packages; Population; Qualifications; Rating tests; Resistance; Sequence of operations; Specification; Specification (approval); Steam; Steam sterilization; Steam sterilizers; Sterilization (hygiene); Sterilizers; Sterilizing apparatus; Sterilizing gases; Surveillance (approval); Survival characteristics; Systems; Test germs; Testing; Use; Validation; Vapours
  • Application areas:
    09.01 Medizinprodukte im Allgemeinen
  • Hazards:
    BA Biologische Gefährdungen im Allgemeinen
  • ICS:
    11.080.01 Sterilization and disinfection in general; 11.080.20 Disinfectants and antiseptics
  • Price:
    72,00 EUR
  • Cross references:
    ISO 11138-1 (2017-03)<S>; ISO 18472 (2018-08)<G>; ISO 17665-1 (2006-08); ISO 11138-7 (2019-03)
  • Cited in:
    DIN EN ISO 6877 (2022-01); DIN EN ISO 10651-5 (2021-11); DIN EN ISO 11138-7 (2019-11); DIN EN ISO 11138-8 (2021-11); DIN EN ISO 11140-1 (2006-04)<GLEITEND>; DIN EN ISO 18472 (2018-11)<STARR>; DIN ISO 11040-7 (2020-11); DIN ISO 21881 (2020-12)<GLEITEND>; DIN ISO 21882 (2020-12)<GLEITEND>; 17/30363625 DC (2017-09-06); 18/30349202 DC (2018-06-08); 18/30349205 DC (2018-06-07); 20/30329920 DC (2020-10-05); 20/30379026 DC (2020-04-22); 21/30327620 DC (2021-07-07); 21/30421406 DC (2021-11-22); BS EN ISO 6877 (2021-09-22); BS EN ISO 11138-7 (2019-05-01); BS EN ISO 11138-8 (2021-07-28); BS ISO 16142-2 (2017-09-20); BS EN ISO 18472 (2018-09-19); BS ISO 21881 (2019-10-24); BS ISO 21882 (2019-10-23); EN ISO 11140-1 (2005-07)<GLEITEND>; EN ISO 18472 (2018-09)<STARR>; NF S98-005 (2018-09-19); ISO 16142-2 (2017-08)<GLEITEND>; ISO 18472 (2018-08)<STARR>; ISO 21881 (2019-10)<GLEITEND>; ISO 21882 (2019-10)<GLEITEND>; OENORM EN ISO 18472 (2018-11-15); SANS 11140-1 (2018-11-05)
  • Identical with:
    DIN EN ISO 11138-3(2017-07)<IDT>; ANSI/AAMI/ISO 11138-3(2017)<IDT>; BS EN ISO 11138-3(2017-04-30)<IDT>; DS/EN ISO 11138-3(2017-04-05)<IDT>; EN ISO 11138-3(2017-03)<IDT>; NF S98-004-3(2017-06-17)<IDT>; CAN/CSA-ISO 11138-3(2017-08-01)<IDT>; SN EN ISO 11138-3(2017-06)<IDT>; OENORM EN ISO 11138-3(2017-07-15)<IDT>; PN-EN ISO 11138-3(2017-05-24)<IDT>; UNE-EN ISO 11138-3(2017-10-11)<IDT>; TS EN ISO 11138-3(2017-04-24)<IDT>
  • Update flag:
    Unchanged