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  • Abstract:
    This Part of ISO 22442 specifies requirements for controls on the sourcing, collection and handling (which includes storage and transport) of animals and tissues for the manufacture of medical devices utilizing materials of animal origin, other than in vitro diagnostic medical devices.
  • Document number:
    DIN EN ISO 22442-2
  • Issuing date:
    2021-04-01
  • Document type:
    Norm
  • Title:
    Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2020); German version EN ISO 22442-2:2020
  • Replaces:
    DIN EN ISO 22442-2(2016-05); DIN EN ISO 22442-2(2018-12)
  • Author:
    Optics and Precision Mechanics Standards Committee
  • Search term:
    Analysis; Animal; Animal products; Animals; Applications; Biological hazards; Bovines; CE marking; Certification; Checks; Collections; Definitions; Derivatives; Fabrics; Feeding; Handling; Impurities; Information; Investigations; Medical devices; Medical products; Medical sciences; Methods; Origin; Pathogenic bacteria; Personnel; Procedures; Procurements; Production; Quality; Risk; Risk analysis; Selection; Specification (approval); Storage; Tissue; Transport; Use; Veterinarians; Winning
  • Application areas:
    09.10 Medizinische Produkte
  • Hazards:
    AB Terminologische Festlegungen in Normen mit Arbeitsschutzbezug; BA Biologische Gefährdungen im Allgemeinen; HD Handhabungsfaktoren (Gestaltung und Anordnung von Bedienelementen, Bewegungsraum, Gestaltung und Handhabbarkeit von Arbeitsmitteln, Sichtfeld, Standsicherheit)
  • ICS:
    11.100.20 Biological evaluation of medical devices
  • Price:
    115,20 EUR
  • Cross references:
    ISO 22442-1 (2020-09)<G>; DIN EN ISO 9001 (2015-11); DIN EN ISO 22442-3 (2008-03); ISO 9001 (2015-09); ISO 13485 (2016-03); ISO 22442-3 (2007-12); ISO/TR 24971 (2020-06); EUV 722/2012 (2012-08-08); DIN EN ISO 13485 (2021-12); DIN EN ISO 14971 (2022-04); DIN EN ISO 22442-1 (2021-08); ISO 14971 (2019-12); EUV 2017/745 (2017-04-05)
  • Cited in:
    DIN EN ISO 5840-1 (2021-05); DIN EN ISO 14160 (2021-11); DIN EN ISO 15798 (2022-05); DIN EN ISO 22442-1 (2021-04); DIN EN ISO 22442-1 (2021-08); DIN EN ISO 25424 (2022-07)
  • Identical with:
    EN ISO 22442-2(2020-12)<IDT>; ISO 22442-2(2020-09)<IDT>
  • Legislation:
    93/42/EWG (1993-06-14)<H>; Medizinprodukterichtlinie; 93/42/EWG (1993-06-14)<M>; Medizinprodukterichtlinie; EUB 2021/610 (2021-04-14)
  • Update flag:
    Unchanged

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