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  • Document number:
    ISO 11737-1
  • Issuing date:
    2018-01-01
  • Document type:
    Norm
  • Title:
    Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products
  • Replaces:
    ISO 11737-1(2006-04); ISO/FDIS 11737-1(2017-09); ISO 11737-1 Technical Corrigendum 1(2007-05)
  • Author:
    ISO/TC 198 Sterilization of health care products
  • Search term:
    Analysis; Applications; Assessment; Bacteria; Bacterial count; Bacteriological quality; Biological hazards; CE marking; Characteristics; Colony count; Concentration; Conditions; Contamination; Corrections; Counting; Culture; Culture media; Definitions; Determination; EDP; Elections; Equipment; Estimation; Evaluations; Filtration; Germs; Guide books; Health protection; Hygiene; Incubation; Inspection; Instruments; Laboratories; Laboratory testing; Limits (mathematics); Loading; Materials; Mathematical calculations; Media; Medical devices; Medical equipment; Medical instruments; Medical products; Medical sciences; Membranes; Methods; Methods of manufacture; Microbiological; Microbiological analysis; Microbiology; Micro-organisms; Microorganisms; Operation; Packages; Patterns; Personal health; Personnel; Population; Products; Quality assurance; Quality management; Raw materials; Reclamation; Release; Safety; Samples; Sampling methods; Selection; Solutions; Specification (approval); Sterile; Sterility; Sterilization (hygiene); Substances; Testing; Transfer; Transport; Treatment; Validation; Verification
  • Application areas:
    09.01 Medizinprodukte im Allgemeinen
  • Hazards:
    AB Terminologische Festlegungen in Normen mit Arbeitsschutzbezug; BB Mikroorganismen (Viren, Bakterien, Parasiten u. Ä.)
  • ICS:
    07.100.10 Medical microbiology; 11.080.01 Sterilization and disinfection in general
  • Price:
    208,00 EUR
  • Cross references:
    ISO 10012 (2003-04)<G>; ISO 13485 (2016-03)<G>; ISO/IEC 17025 (2017-11)<G>; ISO 15189 (2022-12)<G>; ISO 9000 (2015-09); ISO 9001 (2015-09); ISO 11135 (2014-07); ISO 11137-1 (2006-04); ISO 11137-1 AMD 1 (2013-07); ISO 11137-2 (2013-06); ISO 11137-3 (2017-06); ISO 11138-2 (2017-03); ISO 13022 (2012-04); ISO 14937 (2009-10); ISO 17665-1 (2006-08); ISO 20857 (2010-08); ISO 22442-3 (2007-12); ASTM D 4855 (1997); ISO 7870-2 (2023-03); ISO 7870-4 (2021-09); ISO 11737-2 (2019-12); ISO 14160 (2020-09); ISO/IEC/IEEE 90003 (2018-11)
  • Cited in:
    DIN EN ISO 11135 (2020-04)<GLEITEND>; DIN EN ISO 11137-1 (2020-04)<GLEITEND>; DIN EN ISO 11137-2 (2023-08)<GLEITEND>; DIN EN ISO 11138-7 (2019-11); DIN EN ISO 11139 (2019-05); DIN EN ISO 11737-2 (2020-07); DIN EN ISO 13408-2 (2018-06); DIN EN ISO 14160 (2021-11)<GLEITEND>; DIN EN ISO 15883-4 (2019-06); DIN EN ISO 15883-5 (2021-11); DIN EN ISO 22442-1 (2021-04); DIN EN ISO 22442-1 (2021-08); DIN EN ISO 25424 (2020-05)<GLEITEND>; DIN EN ISO 25424 (2022-07)<GLEITEND>; DIN EN ISO 27427 (2020-02); 18/30338923 DC (2018-06-14); 18/30363974 DC (2018-05-02); 18/30375452 DC (2018-08-15); 19/30330682 DC (2019-06-21); 20/30385404 DC (2020-02-26); 20/30422024 DC (2020-12-04); 21/30393482 DC (2021-04-30); 21/30393485 DC (2021-05-07); 21/30396844 DC (2021-03-19); 21/30412844 DC (2021-07-22); 21/30431923 DC (2021-10-19); 23/30424625 DC (2023-04-04); 23/30426672 DC (2023-04-21); BS EN ISO 11138-7 (2019-05-01); BS ISO 11608-6 (2022-04-25); BS EN ISO 11737-2 (2020-05-19); BS ISO 13004 (2022-10-12); BS EN ISO 13408-2 (2018-04-10); BS EN 13795-1 (2019-04-12); BS EN 13795-2 (2019-04-12); BS EN ISO 14160 (2021-07-05); BS EN 14683 (2019-03-27); BS EN ISO 15883-4 (2018-12-19); BS EN ISO 15883-5 (2021-08-18); BS ISO 19227 (2018-04-04); BS ISO 22441 (2022-10-28); BS EN ISO 22442-1 (2020-12-14); PD ISO/TR 24484 (2023-03-09); BS EN ISO 25424+A1 (2019-11-21); PD ISO/TS 20721 (2020-09-16); PD ISO/TS 22456 (2021-03-22); EN ISO 14160 (2021-06)<GLEITEND>; EN ISO 25424 (2019-11)<GLEITEND>; NF S94-091 (2018-08-04); NF S98-002 (2022-10-28); NF S98-008 (2019-11-20); NF S98-112 (2021-06-30); NF S98-300 (2022-12-16); ISO 13004 (2022-10)<STARR>; ISO 14160 (2020-09)<GLEITEND>; ISO 19227 (2018-03)<GLEITEND>; ISO 22441 (2022-08)<GLEITEND>; ISO/TS 22456 (2021-03)<STARR>; ISO 25424 (2018-10)<GLEITEND>; OENORM EN ISO 11135 (2020-04-01); OENORM EN ISO 11137-1 (2020-04-01); OENORM EN ISO 14160 (2021-10-15); SANS 11135; SANS 11138-1 (2018-12-18); SANS 11138-1
  • Identical with:
    DIN EN ISO 11737-1(2018-07)<IDT>; DIN EN ISO 11737-1(2018-11)<IDT>; DIN EN ISO 11737-1(2021-10)<IDT>; ANSI/AAMI/ISO 11737-1(2018)<IDT>; BS EN ISO 11737-1+A1(2018-02-21)<IDT>; DS/EN ISO 11737-1(2018-02-07)<IDT>; EN ISO 11737-1(2018-01)<IDT>; PR NF S98-118-1/A1<IDT>; NF S98-118-1(2018-01-31)<IDT>; NF S98-118-1/A1(2021-06-16)<IDT>; CSA ISO 11737-1(2019-06-01)<IDT>; SN EN ISO 11737-1(2018-07)<IDT>; OENORM EN ISO 11737-1(2019-03-01)<IDT>; OENORM EN ISO 11737-1(2021-11-01)<IDT>; OENORM EN ISO 11737-1/A1(2019-07-01)<IDT>; PN-EN ISO 11737-1(2019-09-20)<IDT>; SS-EN ISO 11737-1(2018-02-12)<IDT>; UNE-EN ISO 11737-1(2018-12-26)<IDT>; SANS 11737-1(2019-03-19)<IDT>; SANS 11737-1<IDT>; KS P ISO 11737-1(2021-06-28)<IDT>; KS P ISO 11737-1(2022-12-28)<IDT>; TS EN ISO 11737-1(2018-03-19)<IDT>
  • Update flag:
    Unchanged

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