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  • Document number:
    EN ISO 10993-12
  • Issuing date:
    2021-06-01
  • Document type:
    Norm
  • Title:
    Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021)
  • Replaces:
    EN ISO 10993-12(2012-07); FprEN ISO 10993-12(2020-06)
  • Author:
    CEN/TC 206 Biocompatibility of medical and dental materials and devices
  • Search term:
    Bioassay; Biological; Biological tests; CE marking; Certification; Checks; Conditions; Cytotoxicity; Definitions; Dental equipment; Dental instruments; Evaluations; Extraction; Extracts; Implants (surgical); Materials; Medical devices; Medical equipment; Medical products; Particles; Patterns; Preparation; Production; Reference materials; References; Samples; Selection; Specification (approval); Specimen preparation; Standards; Surfaces; Surgical equipment; Surgical implants; Surgical instruments; Temperature; Test samples; 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:
    EUV 2017/745 (2017-04-05)
  • Cited in:
    EUB 2022/6 (2022-01-04)<STARR>
  • Identical with:
    DIN EN ISO 10993-12(2021-08)<IDT>; BS EN ISO 10993-12(2021-06-21)<IDT>; NF S99-501-12(2021-06-16)<IDT>; ISO 10993-12(2021-01)<IDT>; SN EN ISO 10993-12(2021-08)<IDT>; OENORM EN ISO 10993-12(2021-09-15)<IDT>; PN-EN ISO 10993-12(2021-11-26)<IDT>; SS-EN ISO 10993-12(2021-06-22)<IDT>; UNE-EN ISO 10993-12(2022-02-16)<IDT>; TS EN ISO 10993-12(2021-09-30)<IDT>
  • Legislation:
    EUV 2017/745 (2017-04-05)<H>; Medizinprodukte-Verordnung; EUV 2017/745 (2017-04-05)<M>; Medizinprodukte-Verordnung; EUB 2022/6 (2022-01-04)
  • Harmonization info:
    EUV 2017/745 (2017-04-05); Medizinprodukte-Verordnung<HARMANFANG>2022-01-05</HARMANFANG>
  • Update flag:
    Unchanged

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