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  • Document number:
    EN ISO 14160
  • Issuing date:
    2021-06-01
  • Document type:
    Norm
  • Title:
    Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices (ISO 14160:2020)
  • Replaces:
    EN ISO 14160(2011-07); prEN ISO 14160(2018-04)
  • Author:
    CEN/TC 204 Sterilization of medical devices
  • Search term:
    Animal; Animal products; Aseptic; Bacterial count; Biological hazards; Calibration; CE marking; Certification; Characterisations; Checks; Chemical; Chemicals; Clearing; Compatibility; Contamination; Definitions; Derivatives; Developments; Disposable; Disposables; Efficiency; Equipment for single use; Evaluations; Fabrics; Germicides; Germs; Guide books; Incubation; Information; Insulations; Kinetics; Liquid; Liquid materials; Liquids; Loading; Media; Medical devices; Medical products; Methods; Microbiological; Micro-organisms; Netting; Neutralization; Performance; Personnel; Production; Products; Public health; Screening-method; Sterile equipment; Sterilization (hygiene); Surveillance (approval); Training; Use; 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; BA Biologische Gefährdungen im Allgemeinen
  • ICS:
    11.080.01 Sterilization and disinfection in general
  • Cross references:
    ISO 10993-1 (2018-08)<G>; ISO 10993-17 (2002-12)<G>; ISO 11737-1 (2018-01)<G>; ISO 13408-1 (2008-06)<G>; ISO 13408-1 AMD 1 (2013-05)<G>; ISO 13408-2 (2018-01)<G>; ISO 13408-3 (2006-09)<G>; ISO 13408-4 (2005-11)<G>; ISO 13408-5 (2006-11)<G>; ISO 13408-7 (2012-08)<G>; ISO 13408-6 (2021-04)<G>; ISO 13408-6 (2021-04)<G>; EUV 2017/745 (2017-04-05)
  • Cited in:
    23/30457240 DC (2023-01-24); 23/30457243 DC (2023-01-24); EUB 2022/6 (2022-01-04)<STARR>
  • Identical with:
    DIN EN ISO 14160(2021-11)<IDT>; BS EN ISO 14160(2021-07-05)<IDT>; NF S98-112(2021-06-30)<IDT>; ISO 14160(2020-09)<IDT>; SN EN ISO 14160(2021-08)<IDT>; OENORM EN ISO 14160(2021-10-15)<IDT>; SS-EN ISO 14160(2021-07-05)<IDT>; UNE-EN ISO 14160(2021-09-01)<IDT>; TS EN ISO 14160(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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