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  • Document number:
    ISO 10993-5
  • Issuing date:
    2009-06-01
  • Document type:
    Norm
  • Title:
    Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
  • Replaces:
    ISO 10993-5(1999-05); ISO/FDIS 10993-5(2009-01)
  • Author:
    ISO/TC 194 Biological evaluation of medical devices
  • Search term:
    Bioassay; Biological analysis and testing; CE marking; Culture media; Cytotoxicity; Definitions; Dental equipment; Dental instruments; Implants (surgical); In vitro; In-vitro diagnostic; Medical devices; Medical equipment; Medical products; Medical sciences; Surgical equipment; Surgical implants; Test methods; Test procedures; Testing
  • Application areas:
    09.10 Medizinische Produkte
  • Hazards:
    AB Terminologische Festlegungen in Normen mit Arbeitsschutzbezug; AC Mess- und Prüfverfahren für die Ermittlung von Belastungen und Gefährdungen; BF Toxische Stoffe
  • ICS:
    11.100.20 Biological evaluation of medical devices
  • Price:
    171,30 EUR
  • Cross references:
    ; ISO 10993-1 (2018-08)<G>; ISO 10993-12 (2021-01)<G>
  • Cited in:
    DIN EN 60601-1 (2013-12)<GLEITEND>; DIN EN ISO 3826-1 (2013-09)<GLEITEND>; DIN EN ISO 3826-1 (2020-01)<GLEITEND>; DIN EN ISO 3826-4 (2015-12)<GLEITEND>; DIN EN ISO 4074 (2016-05)<GLEITEND>; DIN EN ISO 4074 (2016-07)<GLEITEND>; DIN EN ISO 4074 (2017-09)<GLEITEND>; DIN EN ISO 7198 (2017-07)<GLEITEND>; DIN EN ISO 7405 (2013-12)<GLEITEND>; DIN EN ISO 7405 (2019-03)<GLEITEND>; DIN EN ISO 9394 (2013-01); DIN EN ISO 10271 (2020-12); DIN EN ISO 10993-1 (2009-10); DIN EN ISO 10993-1 (2010-04)<GLEITEND>; DIN EN ISO 10993-1 (2021-05)<GLEITEND>; DIN EN ISO 10993-12 (2012-10)<GLEITEND>; DIN EN ISO 10993-12 (2021-08); DIN EN ISO 11135 (2014-10); DIN EN ISO 11135 (2020-04); DIN EN ISO 11979-5 (2021-05)<GLEITEND>; DIN EN ISO 11979-6 (2015-02)<GLEITEND>; DIN EN ISO 12417-1 (2016-02); DIN EN ISO 14155 (2020-12); DIN EN ISO 14155 (2021-05); DIN EN ISO 14155-1 (2009-11); DIN EN ISO 14408 (2009-08); DIN EN ISO 14534 (2011-06); DIN EN ISO 14534 (2015-08); DIN EN ISO 14607 (2018-10)<GLEITEND>; DIN EN ISO 15621 (2017-09); DIN EN ISO 15747 (2010-08)<GLEITEND>; DIN EN ISO 15747 (2012-07)<GLEITEND>; DIN EN ISO 15747 (2019-07)<GLEITEND>; DIN EN ISO 15883-5 (2021-11)<GLEITEND>; DIN EN ISO 16672 (2022-05); DIN EN ISO 18562-2 (2020-05); DIN EN ISO 18562-3 (2020-05); DIN EN ISO 18562-4 (2020-05)<GLEITEND>; DIN EN ISO 20696 (2018-10); DIN EN ISO 20696 (2019-04); DIN EN ISO 20696 (2020-10); DIN EN ISO 21563 (2022-02); DIN EN ISO 21649 (2006-09)<GLEITEND>; DIN EN ISO 21649 (2010-01)<GLEITEND>; DIN EN ISO 22442-1 (2016-05); DIN EN ISO 22442-1 (2021-04); DIN EN ISO 22442-1 (2021-08); DIN EN ISO 22794 (2009-11); DIN EN ISO 25539-1 (2009-08)<GLEITEND>; DIN EN ISO 25539-2 (2021-01)<GLEITEND>; DIN EN ISO 27427 (2020-02); DIN ISO 13022 (2014-06); 09/30195717 DC (2009-09-30); 09/30195720 DC (2009-09-30); 09/30207531 DC (2009-08-19); 10/30196945 DC (2010-04-09); 10/30206199 DC (2010-06-03); 10/30208681 DC (2010-09-13); 10/30233840 DC (2010-10-19); 11/30243462 DC (2011-10-11); 12/30251858 DC (2012-05-23); 12/30261215 DC (2012-07-30); 13/30254047 DC (2013-05-02); 13/30259011 DC (2013-03-28); 13/30273308 DC (2013-10-10); 13/30281504 DC (2013-06-03); 14/30251609 DC (2014-04-10); 14/30281557 DC (2014-07-03); 14/30281856 DC (2014-03-20); 14/30289934 DC (2014-03-19); 14/30290166 DC (2014-04-28); 14/30302761 DC (2014-06-11); 15/30266276 DC (2015-08-17); 15/30278530 DC (2015-11-16); 15/30278534 DC (2015-11-16); 15/30278537 DC (2015-11-16); 15/30278540 DC (2015-11-16); 15/30303073 DC (2015-08-03); 15/30315105 DC (2015-01-28); 15/30330548 DC (2015-11-09); 16/30284330 DC (2016-07-28); 16/30302523 DC (2016-04-21); 16/30312836 DC (2016-02-18); 16/30346829 DC (2016-09-22); 17/30302216 DC (2017-03-09); 17/30336573 DC (2017-02-07); 17/30336577 DC (2017-02-07); 17/30343686 DC (2017-03-09); 17/30344601 DC (2017-02-20); 17/30358658 DC (2017-06-15); 17/30358661 DC (2017-06-16); 17/30359001 DC (2017-03-23); 17/30359567 DC (2017-07-24); 18/30324477 DC (2018-04-04); 18/30344902 DC (2018-06-26); 18/30350509 DC (2018-07-06); 18/30357483 DC (2018-04-03); 18/30357896 DC (2018-11-12); 18/30366615 DC (2018-03-29); 18/30372087 DC (2018-10-22); 18/30375452 DC (2018-08-15); 18/30376766 DC (2018-07-13); 18/30382933 DC (2018-08-30); 19/30330682 DC (2019-06-21); 19/30357590 DC (2019-11-04); 19/30368988 DC (2019-06-04); 19/30372969 DC (2019-07-15); 19/30376763 DC (2019-05-13); 19/30389993 DC (2019-03-20); 19/30394311 DC (2019-10-04); 20/30368566 DC (2020-12-09); 20/30419927 DC (2020-05-06); 20/30422024 DC (2020-12-04); 21/30393482 DC (2021-04-30); 21/30393485 DC (2021-05-07); 21/30396844 DC (2021-03-19); 21/30404480 DC (2020-12-23); 21/30410897 DC (2021-07-22); 21/30429652 DC (2021-10-26); 22/30427231 DC (2022-01-25); 22/30441993 DC (2022-02-15); BS EN 455-3 (2015-04-30); BS EN 1642 (2011-10-31); BS EN ISO 3826-1 (2013-06-30); BS EN ISO 3826-1 (2019-10-25); BS EN ISO 3826-4 (2015-08-31); BS EN ISO 4074 (2015-11-30); BS EN ISO 7198 (2017-03-31); BS EN ISO 7405 (2018-11-28); BS ISO 8009 (2014-11-30); BS EN ISO 9394 (2012-10-31); BS EN ISO 10271 (2020-09-23); BS ISO 10282 (2014-01-31); BS EN ISO 10993-1 (2010-06-30); BS EN ISO 10993-1 (2020-12-16); BS EN ISO 10993-4 (2017-05-25); BS EN ISO 10993-11 (2018-06-18); BS EN ISO 10993-12 (2012-10-31); BS EN ISO 10993-12 (2021-06-21); BS EN ISO 11135+A1 (2014-07-31); BS ISO 11249 (2018-02-16); BS EN ISO 11979-5 (2020-10-12); BS EN ISO 11979-6 (2014-10-31); BS DD ISO/TS 12417 (2011-07-31); BS EN ISO 12417-1 (2015-10-31); BS EN 13060+A1 (2014-12-31); BS EN 13795-1 (2019-04-12); BS EN 13795-2 (2019-04-12); BS EN ISO 14155 (2011-02-28); BS EN ISO 14155 (2020-08-19); BS EN ISO 14155-1 (2010-01-31); BS EN ISO 14408 (2011-09-30); BS EN ISO 14534 (2009-07-31); BS EN ISO 14534 (2011-04-30); BS EN ISO 14534 (2015-02-28); BS EN ISO 14607 (2018-05-24); BS EN 14683 (2014-04-30); BS EN 14683 (2019-03-27); BS EN ISO 15621 (2017-08-11); BS ISO 15621 (2011-03-31); BS EN ISO 15747 (2009-07-31); BS EN ISO 15747 (2010-05-31); BS EN ISO 15747 (2011-11-30); BS EN ISO 15747 (2019-03-11); BS EN ISO 15883-1+A1 (2009-10-31); BS EN ISO 15883-5 (2021-08-18); BS ISO 16038 (2018-01-03); BS ISO 16142-1 (2016-03-31); BS EN ISO 16672 (2021-10-14); BS EN 16820 (2017-08-25); BS ISO 16840-10 (2021-06-14); BS ISO 17218 (2014-05-31); BS ISO 18189 (2016-06-30); BS ISO 18340 (2020-07-17); BS ISO 18385 (2016-02-29); BS EN ISO 18562-2 (2017-03-31); BS EN ISO 18562-3 (2017-03-31); BS EN ISO 18562-4 (2017-03-31); BS ISO 19007 (2018-04-18); BS ISO 19090 (2018-02-16); BS ISO 19227 (2018-04-04); BS ISO 19351 (2019-07-22); BS ISO 19611 (2017-06-28); BS ISO 20069 (2019-08-07); BS EN ISO 20696 (2018-07-11); BS EN ISO 21563 (2021-09-15); BS EN ISO 21649 (2009-11-30); BS ISO 22166-1 (2021-02-04); BS EN ISO 22442-1 (2015-11-30); BS EN ISO 22442-1 (2020-12-14); BS EN ISO 22794 (2009-09-30); BS ISO 23409 (2011-03-31); BS EN ISO 25539-1 (2009-12-31); BS EN ISO 25539-2 (2009-09-30); BS EN ISO 25539-2 (2010-02-28); BS EN ISO 25539-2 (2020-10-06); BS EN ISO 25539-3 (2012-03-31); BS ISO 25841 (2014-01-31); BS ISO 25841+A1 (2017-09-18); BS EN ISO 27427 (2014-02-28); BS ISO 28620 (2010-03-31); BS ISO 29942 (2011-07-31); PD ISO/TR 37137 (2014-06-30); BS EN IEC 80601-2-77 (2021-07-06); PD CEN/TR 16953 (2017-12-13); PD IEC/TR 60601-4-3 (2015-04-30); PD IEC/TR 60601-4-3 (2019-01-04); PD IEC/TR 62809 (2013-10-31); PD IEC/TR 62809 (2019-10-30); PD ISO/IEC Guide 63 (2019-08-21); PD ISO/TS 17137 (2014-06-30); PD ISO/TS 17137 (2019-09-10); PD ISO/TS 17137 (2021-09-17); PD ISO/TS 18340 (2015-10-31); PD ISO/TS 18827 (2017-07-28); PD ISO/TS 19006 (2016-08-31); PD ISO/TS 19218-2 (2012-05-31); PD ISO/TS 19930 (2017-12-01); PD ISO/TS 20721 (2020-09-16); PD ISO/TS 37137-1 (2021-03-15); CWA 17253-2 (2018-03); EN ISO 3826-1 (2013-06)<GLEITEND>; EN ISO 3826-1 (2019-10)<GLEITEND>; EN ISO 3826-4 (2015-08)<GLEITEND>; EN ISO 4074 (2015-11)<GLEITEND>; EN ISO 7198 (2017-03)<GLEITEND>; EN ISO 7405 (2018-11)<GLEITEND>; EN ISO 10993-1 (2009-10)<GLEITEND>; EN ISO 10993-1 (2020-12)<GLEITEND>; EN ISO 10993-4 (2017-05); EN ISO 10993-12 (2012-07)<GLEITEND>; EN ISO 11135 (2014-07); EN ISO 11979-5 (2020-10)<GLEITEND>; EN ISO 11979-6 (2014-10)<GLEITEND>; EN ISO 12417-1 (2015-10); EN ISO 14607 (2018-05)<GLEITEND>; EN ISO 15621 (2017-07); EN ISO 15747 (2010-04)<GLEITEND>; EN ISO 15747 (2011-10)<GLEITEND>; EN ISO 15747 (2019-03)<GLEITEND>; EN ISO 15883-5 (2021-08)<GLEITEND>; EN ISO 17510-2 (2007-10)<GLEITEND>; EN ISO 18562-4 (2020-02)<GLEITEND>; EN ISO 21649 (2006-06)<GLEITEND>; EN ISO 21649 (2009-09)<GLEITEND>; EN ISO 22442-1 (2015-11); EN ISO 25539-1 (2008-10)<GLEITEND>; EN ISO 25539-1 (2009-05)<GLEITEND>; EN ISO 25539-2 (2020-09)<GLEITEND>; EN ISO 25539-3 (2011-12)<GLEITEND>; NF C74-370 (2015-09-19); NF C74-372 (2015-09-19); NF C74-373 (2015-08-29); NF S91-224 (2018-11-28); NF S93-021 (2009-12-01); NF S93-025 (2010-04-01); NF S93-105 (2010-06-01); NF S93-105 (2012-03-01); NF S93-105 (2019-03-06); NF S93-230-1 (2013-08-10); NF S93-230-1 (2019-10-16); NF S93-230-4 (2015-10-23); NF S94-091 (2018-08-04); NF S94-203-2 (2020-09-30); NF S94-203-3 (2012-02-01); NF S94-204 (2017-09-09); NF S94-350 (2018-05-16); NF S94-750-5 (2020-10-07); NF S94-750-6 (2014-12-05); NF S95-181 (2009-10-01); NF S95-189-4 (2017-05-26); NF S95-189-4 (2020-02-19); NF S97-036 (2015-12-25); NF S98-040-5 (2021-08-18); NF S99-501-1 (2010-07-01); NF S99-501-1 (2020-12-16); NF S99-501-12 (2012-09-01); FD S99-501-22 (2017-08-23); IEC 60601-1 Edition 3.1 (2012-08)<GLEITEND>; IEC 60601-1 Edition 3.2 (2020-08)<GLEITEND>; ISO 3826-1 (2013-06)<GLEITEND>; ISO 3826-1 (2019-09)<GLEITEND>; ISO 3826-4 (2015-08)<GLEITEND>; ISO 4074 (2014-08)<GLEITEND>; ISO 4074 (2015-10)<GLEITEND>; ISO 7198 (2016-08)<GLEITEND>; ISO 7405 (2018-10)<GLEITEND>; ISO 8009 (2014-11)<GLEITEND>; ISO 10282 (2014-02)<GLEITEND>; ISO 10993-1 (2009-10)<GLEITEND>; ISO 10993-1 (2018-08)<GLEITEND>; ISO 10993-4 (2017-04); ISO 10993-11 (2017-09); ISO 10993-12 (2012-07)<GLEITEND>; ISO/TR 10993-22 (2017-07)<GLEITEND>; ISO 11135 (2014-07); ISO 11193-1 (2020-08)<GLEITEND>; ISO 11249 (2018-02); ISO 11979-5 (2020-09)<GLEITEND>; ISO 11979-6 (2014-10)<GLEITEND>; ISO 12417-1 (2015-10); ISO/TR 12417-2 (2017-11); ISO 14607 (2018-04)<GLEITEND>; ISO 15621 (2017-06); ISO 15747 (2010-04)<GLEITEND>; ISO 15747 (2018-09)<GLEITEND>; ISO 15883-1 AMD 1 (2014-07); ISO 15883-5 (2021-07)<GLEITEND>; ISO 16038 (2017-11); ISO 16142-1 (2016-03)<GLEITEND>; ISO/TS 17137 (2014-05)<GLEITEND>; ISO/TS 17137 (2019-09)<GLEITEND>; ISO/TS 17137 (2021-09)<GLEITEND>; ISO 18189 (2016-06); ISO/TS 18340 (2015-10); ISO 18385 (2016-02); ISO 18562-2 (2017-03); ISO 18562-3 (2017-03); ISO 18562-4 (2017-03)<GLEITEND>; ISO/TS 18827 (2017-06); ISO/TS 19006 (2016-08); ISO 19007 (2018-04); ISO 19090 (2018-01)<GLEITEND>; ISO 19227 (2018-03)<GLEITEND>; ISO 19351 (2019-07)<GLEITEND>; ISO 19611 (2017-05)<GLEITEND>; ISO/TS 19930 (2017-12); ISO 20696 (2018-06); ISO 22442-1 (2015-11); ISO 23409 (2011-02)<GLEITEND>; ISO 25539-2 (2020-09)<GLEITEND>; ISO 25539-3 (2011-12)<GLEITEND>; ISO 25841 (2011-07)<GLEITEND>; ISO 25841 (2014-01)<GLEITEND>; ISO 25841 (2017-08)<GLEITEND>; ISO 28620 (2010-02)<GLEITEND>; ISO 29942 (2011-07)<GLEITEND>; ISO/TR 37137 (2014-05); ISO/TS 37137-1 (2021-03)<GLEITEND>; ISO 80601-2-67 (2014-06)<GLEITEND>; OENORM EN ISO 3826-1 (2013-09-01); OENORM EN ISO 3826-1 (2020-02-01); OENORM EN ISO 3826-4 (2015-12-15); OENORM EN ISO 4074 (2016-12-15); OENORM EN ISO 4074 (2017-11-15); OENORM EN ISO 7198 (2017-06-15); OENORM EN ISO 7405 (2013-12-15); OENORM EN ISO 7405 (2019-03-01); OENORM EN ISO 10993-1 (2010-03-15); OENORM EN ISO 10993-1 (2011-03-15); OENORM EN ISO 10993-1 (2021-04-15); OENORM EN ISO 10993-12 (2012-10-01); OENORM EN ISO 11979-5 (2021-04-15); OENORM EN ISO 11979-6 (2015-01-01); OENORM EN ISO 14607 (2018-11-15); OENORM EN ISO 15747 (2010-08-01); OENORM EN ISO 15747 (2012-01-15); OENORM EN ISO 15747 (2019-06-15); OENORM EN ISO 15883-5 (2021-12-01); OENORM EN ISO 17510-2 (2009-07-15); OENORM EN ISO 18562-4 (2020-06-01); OENORM EN ISO 21649 (2010-02-01); OENORM EN ISO 25539-1 (2009-10-15); OENORM EN ISO 25539-1 (2011-03-15); OENORM EN ISO 25539-2 (2009-09-15); OENORM EN ISO 25539-2 (2011-03-15); OENORM EN ISO 25539-2 (2021-03-01); OENORM EN ISO 25539-3 (2012-03-01); OEVE/OENORM EN 60601-1 (2014-02-01); SANS 10993-1 (2010-08-11); SANS 11193-1 (2010-06-11); SANS 23409 (2011-11-23); SANS 25841 (2011-11-23); SANS 60601-1 (2014-01-15); SANS 60601-2-19 (2016-12-13); SANS 60601-2-21 (2016-12-13); SANS 60601-2-28 (2011-02-15); SANS 60601-2-33 (2011-02-15); SANS 60601-2-33 (2015-02-20); SANS 60601-2-33 (2016-12-13); SANS 60601-2-43 (2011-02-15); SANS 60601-2-43 (2019-03-28); SANS 60601-2-43; SANS 60601-2-50 (2010-02-17); SANS 60601-2-50 (2016-12-13); SANS 60601-2-52 (2011-02-28); SANS 60601-2-52 (2016-12-15); SANS 80601-2-56 (2010-08-18); GOST ISO/TR 10993-22 (2020); GOST ISO 8009 (2013); GOST ISO 8009 (2019); GOST ISO 10282 (2017); GOST ISO 10993-1 (2021); GOST ISO 10993-12 (2015); GOST ISO 23409 (2014); GOST R IEC 60601-1 (2010); GOST R ISO 3826-1 (2021); GOST R ISO 3826-4 (2021); GOST R ISO 7405 (2011); GOST R ISO 8871-4 (2010); GOST R ISO 15142-2 (2017); GOST R ISO 25539-1 (2012); GOST R ISO 25539-2 (2012); GOST 32336 (2013)
  • Identical with:
    DIN EN ISO 10993-5(2009-10)<IDT>; ANSI/AAMI/ISO 10993-5(2009)<IDT>; BS EN ISO 10993-5(2009-07-31)<IDT>; GB/T 16886.5(2017)<IDT>; DS/EN ISO 10993-5(2009-07-24)<IDT>; EN ISO 10993-5(2009-06)<IDT>; NF S99-501-5(2010-07-01)<IDT>; SN EN ISO 10993-5(2009-11)<IDT>; OENORM EN ISO 10993-5(2009-12-01)<IDT>; PN-EN ISO 10993-5(2009-11-30)<IDT>; SS-EN ISO 10993-5(2009-06-15)<IDT>; UNE-EN ISO 10993-5(2009-12-09)<IDT>; SANS 10993-5(2010-08-11)<IDT>; KS P ISO 10993-5(2018-08-22)<IDT>; TS EN ISO 10993-5(2010-07-12)<IDT>
  • Update flag:
    Unchanged