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Ergonomic standard
  • Document number:
    ISO 22442-1
  • Issuing date:
    2020-09-01
  • Document type:
    Norm
  • Title:
    Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management
  • Replaces:
    ISO 22442-1(2015-11); ISO/FDIS 22442-1(2020-02)
  • Author:
    ISO/TC 194 Biological evaluation of medical devices
  • Search term:
    Acceptance; Accessories; Analysis; Animal; Animal products; Animals; Applications; Biological hazards; Calibration; CE marking; Collagen; Computer software; Consumption; Contact; Context; Definitions; Derivatives; Disposables; Energy; Environment; Environmental effects; Establishment; Examination (quality assurance); Fabrics; Handling; Health protection; Impurities; Information; Interaction; Life (durability); Loss; Maintenance; Materials; Measurement; Medical devices; Medical products; Medical sciences; Medicaments; Methods; Organisms; Origin; Pathogenic bacteria; People; Procedures; Procurements; Production; Products; Properties; Qualitative; Quantitative; Reuse; Risk; Risk analysis; Risk management; Safety; Specification (approval); Sterile; Sterilization (birth control); Storage time; Tissue; Use; Viruses
  • Application areas:
    09.10 Medizinische Produkte
  • Hazards:
    AB Terminologische Festlegungen in Normen mit Arbeitsschutzbezug; BA Biologische Gefährdungen im Allgemeinen
  • ICS:
    11.100.20 Biological evaluation of medical devices
  • Price:
    155,30 EUR
  • Cross references:
    ISO 10993-1 (2018-08)<G>; ISO 14971 (2019-12)<G>; ISO 22442-2 (2020-09)<G>; ISO 22442-3 (2007-12)<G>
  • Cited in:
    DIN EN ISO 5840-1 (2021-05)<GLEITEND>; DIN EN ISO 10993-18 (2021-03); DIN EN ISO 14160 (2021-11); DIN EN ISO 15798 (2022-05)<GLEITEND>; DIN EN ISO 21856 (2022-12)<GLEITEND>; DIN EN ISO 22442-2 (2021-04)<GLEITEND>; DIN EN ISO 25424 (2022-07); 21/30396844 DC (2021-03-19); 21/30406209 DC (2021-01-06); 22/30399894 DC (2022-09-21); BS EN ISO 5840-1 (2021-02-08); BS EN ISO 14160 (2021-07-05); BS EN ISO 15798 (2022-07-19); BS EN ISO 20342-1 (2022-08-05); BS EN ISO 21856 (2022-07-21); BS EN ISO 22442-2 (2020-12-14); BS ISO 22679 (2021-12-01); PD ISO/TS 21560 (2020-10-02); EN ISO 5840-1 (2021-02)<GLEITEND>; EN ISO 15798 (2022-02)<GLEITEND>; EN ISO 20342-1 (2022-08)<GLEITEND>; EN ISO 21856 (2022-07)<GLEITEND>; EN ISO 22442-2 (2020-12)<GLEITEND>; NF S94-200-1 (2021-02-03); NF S94-751 (2022-02-09); NF S96-003-1 (2022-08-03); NF S96-301 (2022-07-20); NF S97-601-2 (2020-12-09); ISO 5840-1 (2021-01)<GLEITEND>; ISO 15798 (2022-01)<GLEITEND>; ISO 20342-1 (2022-07)<GLEITEND>; ISO 21856 (2022-07)<GLEITEND>; ISO 22442-2 (2020-09)<GLEITEND>; ISO 22679 (2021-11)<GLEITEND>; OENORM EN ISO 5840-1 (2021-07-15); OENORM EN ISO 15798 (2022-05-15); OENORM EN ISO 20342-1 (2023-02-15); OENORM EN ISO 21856 (2022-12-15); OENORM EN ISO 22442-2 (2021-05-15); GOST R ISO 19894 (2021)
  • Identical with:
    DIN EN ISO 22442-1(2021-04)<IDT>; DIN EN ISO 22442-1(2021-08)<IDT>; BS EN ISO 22442-1(2020-12-14)<IDT>; EN ISO 22442-1(2020-12)<IDT>; NF S97-601-1(2020-12-09)<IDT>; OENORM EN ISO 22442-1(2021-05-15)<IDT>; PN-EN ISO 22442-1(2021-04-29)<IDT>; SS-EN ISO 22442-1(2020-12-16)<IDT>; UNE-EN ISO 22442-1(2022-01-19)<IDT>; KS P ISO 22442-1(2022-12-28)<IDT>; TS EN ISO 22442-1(2021-02-15)<IDT>
  • Update flag:
    Unchanged

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