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  • Document number:
    EN ISO 10993-11
  • Issuing date:
    2018-05-01
  • Document type:
    Norm
  • Title:
    Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)
  • Replaces:
    EN ISO 10993-11(2009-04); FprEN ISO 10993-11(2017-05)
  • Author:
    CEN/TC 206 Biocompatibility of medical and dental materials and devices
  • Search term:
    Abbreviated description; Animal husbandry; Bioassay; Biological; Biological analysis and testing; Biological hazards; Biological tests; CE marking; Conditions; Definitions; Dental equipment; Dental materials; Design; Determination; Dosage; Dose; Evaluations; Extraction; Health protection; Implants (surgical); Information; Inhalation; Limits (mathematics); Measurement; Measuring techniques; Medical devices; Medical equipment; Medical products; Methods; Methods of analysis; Preparation; Production; Quality assurance; Quality assurance systems; Recommendation; Residual content; Residue; Residues; Samples; Selection; Specification (approval); Specimen preparation; Status; Sterilization (hygiene); Surgical equipment; Surgical implants; Testing; Toxicity; Validation
  • 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 10993-2 (2022-11)<G>; ASTM F 619 (2020); EUV 2017/745 (2017-04-05); EUV 2017/745 (2017-04-05)
  • Cited in:
    DIN EN 13060 (2019-02); DIN EN 14683 (2019-06); DIN EN 14683 (2019-10); 20/30401755 DC (2020-04-01); 20/30419927 DC (2020-05-06); BS EN 14683 (2019-03-27); prEN 455-3 (2005-03)<GLEITEND>; OVE EN 50637 (2018-08-01); EUB 2020/437 (2020-03-24)<STARR>; EUB 2020/438 (2020-03-24)<STARR>
  • Identical with:
    DIN EN ISO 10993-11(2018-09)<IDT>; BS EN ISO 10993-11(2018-06-18)<IDT>; DS/EN ISO 10993-11(2018-06-07)<IDT>; NF S99-501-11(2018-05-30)<IDT>; ISO 10993-11(2017-09)<IDT>; SN EN ISO 10993-11(2018-10)<IDT>; OENORM EN ISO 10993-11(2018-10-15)<IDT>; PN-EN ISO 10993-11(2018-08-28)<IDT>; SS-EN ISO 10993-11(2018-06-05)<IDT>; UNE-EN ISO 10993-11(2018-12-26)<IDT>; TS EN ISO 10993-11(2018-11-19)<IDT>; TS EN ISO 10993-11(2021-06-16)<IDT>
  • Legislation:
    90/385/EWG (1990-06-20)<H>; Aktive implantierbare medizinische Geräte-Richtlinie; 93/42/EWG (1993-06-14)<H>; Medizinprodukterichtlinie; EUB 2020/437 (2020-03-24); EUB 2020/438 (2020-03-24)
  • Update flag:
    Unchanged