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  • Document number:
    EN ISO 10993-23
  • Issuing date:
    2021-03-01
  • Document type:
    Norm
  • Title:
    Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)
  • Replaces:
    FprEN ISO 10993-23(2020-07)
  • Author:
    CEN/TC 206 Biocompatibility of medical and dental materials and devices
  • Search term:
    Alloys; Biological; Biological tests; CE marking; Checks; Chemical composition; Conditions; Cytotoxicity; Definitions; Dental equipment; Dental instruments; Evaluations; Extracts; Implants (surgical); In vitro; In vivo; Interpretations; Irritant effect; Irritants; Irritation; Materials; Medical devices; Medical equipment; Medical products; Particles; Patterns; Polymers; Production; Selection; Skin (body); Specification (approval); Surfaces; Surgical equipment; Surgical implants; Surgical instruments; 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
  • Cross references:
    ISO 10993-1 (2018-08)<G>; ISO 10993-9 (2019-11)<G>; ISO 10993-12 (2021-01)<G>; ISO 10993-13 (2010-06)<G>; ISO 10993-14 (2001-11)<G>; ISO 10993-15 (2019-11)<G>; ISO 10993-18 (2020-01)<G>; ISO 14155 (2020-07)<G>; OECD Test 404 (2015-07-28)<G>; ISO 10993-2 (2022-11)<G>; OECD Test 439 (2021-06-14)<G>; EUV 2017/745 (2017-04-05); EUV 2017/745 (2017-04-05); EUV 2017/745 (2017-04-05)
  • Cited in:
    EUB 2021/1182 (2021-07-16)<STARR>
  • Identical with:
    DIN EN ISO 10993-23(2021-10)<IDT>; 19/30372368 DC(2019-05-13)<IDT>; BS EN ISO 10993-23(2021-04-09)<IDT>; NF S99-501-23(2021-03-31)<IDT>; ISO 10993-23(2021-01)<IDT>; SN EN ISO 10993-23(2021-06)<IDT>; OENORM EN ISO 10993-23(2021-09-15)<IDT>; PN-EN ISO 10993-23(2021-08-18)<IDT>; SS-EN ISO 10993-23(2021-04-06)<IDT>; UNE-EN ISO 10993-23(2021-10-13)<IDT>; TS EN ISO 10993-23(2021-04-12)<IDT>
  • Legislation:
    EUV 2017/745 (2017-04-05)<H>; Medizinprodukte-Verordnung; EUV 2017/745 (2017-04-05)<M>; Medizinprodukte-Verordnung; 90/385/EWG (1990-06-20)<M>; Aktive implantierbare medizinische Geräte-Richtlinie; 93/42/EWG (1993-06-14)<M>; Medizinprodukterichtlinie; EUB 2021/1182 (2021-07-16)
  • Harmonization info:
    EUV 2017/745 (2017-04-05); Medizinprodukte-Verordnung<HARMANFANG>2021-07-19</HARMANFANG>
  • Update flag:
    Unchanged

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