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  • Document number:
    ISO 10993-3
  • Issuing date:
    2014-10-01
  • Document type:
    Norm
  • Title:
    Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • Replaces:
    ISO 10993-3(2003-10); ISO/FDIS 10993-3(2014-06)
  • Author:
    ISO/TC 194 Biological evaluation of medical devices
  • Search term:
    Bioassay; Biological; Biological hazards; Biological tests; Carcinogenic materials; Carcinogens; CE marking; Definitions; Dental equipment; Dental instruments; Dental materials; Evaluations; Fine mechanics; Genes; Genetics; Genotoxicity; Implants (surgical); In vitro; In vivo; Materials; Medical devices; Medical equipment; Medical sciences; Methods; Preparation; Reproductions; Reproductive system; Sample preparation; Samples; Surgical equipment; Surgical implants; Testing; Toxicity
  • 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 10993-2 (2006-07)<G>; OECD Test 416 (2001-01-22)<G>; OECD Test 487 (2016-07-29)<G>; ISO 10993-1 (2018-08)<G>; ISO 10993-6 (2016-12)<G>; ISO 10993-12 (2021-01)<G>; ISO 10993-18 (2020-01)<G>; OECD Test 414 (2018-06-25)<G>; OECD Test 415 (1983-05-26)<G>; OECD Test 421 (2016-07-29)<G>; OECD Test 451 (2018-06-25)<G>; OECD Test 453 (2018-06-25)<G>; OECD Test 471 (2020-06-26)<G>; OECD Test 473 (2016-07-29)<G>; OECD Test 476 (2016-07-29)<G>; ASTM F 1439 (2003); OECD Test 485 (1986-10-23); OECD Test 486 (1997-07-21); OECD Test 474 (2016-07-29); OECD Test 475 (2016-07-29); OECD Test 478 (2016-07-29); OECD Test 479 (1986-10-23); OECD Test 480 (1986-10-23); OECD Test 481 (1986-10-23); OECD Test 482 (1986-10-23); OECD Test 483 (2016-07-29); OECD Test 484 (1986-10-23); OECD Test 488 (2020-06-26)
  • Cited in:
    DIN EN ISO 3826-1 (2020-01); DIN EN ISO 7198 (2017-07)<GLEITEND>; DIN EN ISO 7405 (2019-03)<GLEITEND>; DIN EN ISO 10271 (2020-12); DIN EN ISO 10993-1 (2021-05)<GLEITEND>; DIN EN ISO 10993-3 (2015-02); DIN EN ISO 10993-12 (2021-08); DIN EN ISO 11135 (2020-04); DIN EN ISO 11979-5 (2021-05)<GLEITEND>; DIN EN ISO 12417-1 (2016-02); DIN EN ISO 14155 (2020-12); DIN EN ISO 14155 (2021-05); DIN EN ISO 14534 (2015-08); DIN EN ISO 15621 (2017-09); DIN EN ISO 18562-2 (2020-05); DIN EN ISO 18562-3 (2020-05); DIN EN ISO 18562-4 (2020-05); 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 22442-1 (2016-05); DIN EN ISO 22442-1 (2021-04); DIN EN ISO 22442-1 (2021-08); DIN EN ISO 25539-2 (2021-01)<GLEITEND>; DIN EN ISO 27427 (2020-02); 15/30278530 DC (2015-11-16); 15/30278534 DC (2015-11-16); 15/30278537 DC (2015-11-16); 15/30278540 DC (2015-11-16); 15/30330548 DC (2015-11-09); 16/30302523 DC (2016-04-21); 16/30346829 DC (2016-09-22); 17/30336573 DC (2017-02-07); 17/30336577 DC (2017-02-07); 17/30343686 DC (2017-03-09); 17/30344601 DC (2017-02-20); 17/30359001 DC (2017-03-23); 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); 19/30357590 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); 21/30396844 DC (2021-03-19); 21/30410897 DC (2021-07-22); 21/30429652 DC (2021-10-26); 22/30441993 DC (2022-02-15); BS EN ISO 3826-1 (2019-10-25); BS EN ISO 7198 (2017-03-31); BS EN ISO 7405 (2018-11-28); BS EN ISO 10271 (2020-09-23); 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 (2021-06-21); BS ISO 11249 (2018-02-16); BS EN ISO 11979-5 (2020-10-12); BS EN ISO 12417-1 (2015-10-31); BS EN 13060+A1 (2014-12-31); BS EN ISO 14155 (2020-08-19); BS EN ISO 14534 (2015-02-28); BS EN 14683 (2019-03-27); BS ISO 16142-1 (2016-03-31); 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 19351 (2019-07-22); BS ISO 20069 (2019-08-07); BS EN ISO 20696 (2018-07-11); BS EN ISO 21563 (2021-09-15); 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 25539-2 (2020-10-06); BS ISO 25841+A1 (2017-09-18); BS EN IEC 80601-2-77 (2021-07-06); PD IEC/TR 60601-4-3 (2015-04-30); PD IEC/TR 60601-4-3 (2019-01-04); PD IEC/TR 62809 (2019-10-30); PD ISO/IEC Guide 63 (2019-08-21); PD ISO/TS 17137 (2019-09-10); PD ISO/TS 17137 (2021-09-17); PD ISO/TS 18340 (2015-10-31); PD ISO/TS 19930 (2017-12-01); PD ISO/TS 20721 (2020-09-16); PD ISO/TS 37137-1 (2021-03-15); EN ISO 7198 (2017-03)<GLEITEND>; EN ISO 7405 (2018-11)<GLEITEND>; EN ISO 10993-1 (2020-12)<GLEITEND>; EN ISO 10993-4 (2017-05); EN ISO 10993-7 (2008-10)<GLEITEND>; EN ISO 11979-5 (2020-10)<GLEITEND>; EN ISO 12417-1 (2015-10); EN ISO 15621 (2017-07); EN ISO 17510-2 (2007-10)<GLEITEND>; EN ISO 21649 (2006-06)<GLEITEND>; EN ISO 22442-1 (2015-11); EN ISO 25539-1 (2008-10)<GLEITEND>; EN ISO 25539-2 (2020-09)<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 S94-203-2 (2020-09-30); NF S94-204 (2017-09-09); NF S94-750-5 (2020-10-07); NF S99-501-1 (2020-12-16); FD S99-501-22 (2017-08-23); IEC 60601-1 Edition 3.2 (2020-08)<GLEITEND>; ISO 7198 (2016-08)<GLEITEND>; ISO 7405 (2018-10)<GLEITEND>; ISO 10993-1 (2018-08)<GLEITEND>; ISO 10993-4 (2017-04); ISO 10993-11 (2017-09); ISO/TR 10993-22 (2017-07)<GLEITEND>; ISO 11193-1 (2020-08)<GLEITEND>; ISO 11249 (2018-02); ISO 11979-5 (2020-09)<GLEITEND>; ISO 12417-1 (2015-10); ISO/TR 12417-2 (2017-11); ISO 15621 (2017-06); ISO 16142-1 (2016-03)<GLEITEND>; ISO/TS 17137 (2019-09)<GLEITEND>; ISO/TS 17137 (2021-09)<GLEITEND>; ISO/TS 18340 (2015-10); ISO 18385 (2016-02); ISO 18562-2 (2017-03); ISO 18562-3 (2017-03); ISO 18562-4 (2017-03); 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 25539-2 (2020-09)<GLEITEND>; ISO 25841 (2017-08); ISO/TS 37137-1 (2021-03)<GLEITEND>; OENORM EN ISO 7198 (2017-06-15); OENORM EN ISO 7405 (2019-03-01); OENORM EN ISO 10993-1 (2021-04-15); OENORM EN ISO 11979-5 (2021-04-15); OENORM EN ISO 25539-2 (2021-03-01); SANS 60601-2-19 (2016-12-13); SANS 60601-2-21 (2016-12-13); SANS 60601-2-33 (2015-02-20); SANS 60601-2-33 (2016-12-13); SANS 60601-2-43 (2019-03-28); SANS 60601-2-43; SANS 60601-2-50 (2016-12-13); SANS 60601-2-52 (2016-12-15); GOST ISO/TR 10993-22 (2020); GOST ISO 10282 (2017); GOST ISO 10993-1 (2021); GOST ISO 10993-7 (2016); GOST ISO 10993-12 (2015); GOST R ISO 15142-2 (2017)
  • Identical with:
    DIN EN ISO 10993-3(2015-02)<IDT>; ANSI/AAMI/ISO 10993-3(2014)<IDT>; ABNT NBR ISO 10993-3(2021-12-21)<IDT>; BS EN ISO 10993-3(2014-10-31)<IDT>; GB/T 16886.3(2019)<IDT>; DS/EN ISO 10993-3(2014-11-27)<IDT>; EN ISO 10993-3(2014-10)<IDT>; NF S99-501-3(2014-12-05)<IDT>; SN EN ISO 10993-3(2014-12)<IDT>; OENORM EN ISO 10993-3(2015-01-01)<IDT>; PN-EN ISO 10993-3(2014-12-09)<IDT>; SS-EN ISO 10993-3(2014-10-19)<IDT>; UNE-EN ISO 10993-3(2015-05-06)<IDT>; SANS 10993-3(2021-08-26)<IDT>; SANS 10993-3<IDT>; KS P ISO 10993-3(2018-08-22)<IDT>; GOST ISO 10993-3(2018)<IDT>
  • Update flag:
    Unchanged