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  • Abstract:
    This European Standard specifies requirements and tests for LTSF sterilizers, which use a mixture of low temperature steam and formaldehyde as sterilizing agent, and which are working below ambient pressure only. <Absatz> These sterilizers are primarily used for the sterilization of heat labile medical devices in health care facilities. <Absatz> This European Standard specifies minimum requirements:<Absatz> <(Liste) for the performance and design of sterilizers to ensure that the process is capable of sterilizing medical devices;><Absatz> <(Liste) for the equipment and controls of these sterilizers necessary for the validation and routine control of the sterilization processes.>
  • Document number:
    DIN EN 14180
  • Issuing date:
    2014-09-01
  • Document type:
    Norm
  • Title:
    Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing; German version EN 14180:2014
  • Replaces:
    DIN EN 14180(2010-01); DIN EN 14180(2012-06)
  • Author:
    Medical Standards Committee
  • Search term:
    Definitions; Design; Dimensions; Equipment safety; Formaldehyde; Gas sterilizers; Information; Instructions for use; Low temperatures; Marking; Materials; Medical devices; Medical equipment; Medical products; Medical sciences; Medical technology; Methods; Output determination; Performance requirements; Safety engineering; Safety of products; Safety requirements; Sound level; Sound power; Specification (approval); Sterilization (hygiene); Sterilizers; Testing; Vapours
  • Application areas:
    09.05 Medizinische Geräte und Instrumente
  • Hazards:
    AB Terminologische Festlegungen in Normen mit Arbeitsschutzbezug; CE Gefährdungsart: reizend/ätzend; CG Gefährdungsart: giftig; HI Mangelhafte Gebrauchsanweisungen und Betriebsanleitungen
  • ICS:
    11.080.10 Sterilizing equipment
  • Price:
    173,30 EUR
  • Cross references:
    EN 14222 (2003-04){historisch}<S>; EN 60751 (2008-09)<S>; EN 61010-1 (2010-10)<S>; EN 61010-2-040 (2005-07){historisch}<S>; EN 61326-1 (2013-01){historisch}<S>; EN ISO 228-1 (2003-02)<S>; EN ISO 3746 (2010-12)<S>; EN ISO 11138-1 (2006-07){historisch}<S>; EN ISO 14971 (2012-07){historisch}<S>; EN 764-7 (2002-05)<G>; EN 867-5 (2001-08)<G>; EN 868-5 (2018-12)<G>; EN 60584-1 (2013-12)<G>; EN ISO 16396-1 (2015-02)<G>; EN ISO 11138-5 (2017-03)<G>; EN ISO 15223-1 (2021-09)<G>; DIN ISO 3781 (2012-07); DIN ISO 8787 (1994-06); EN 61508-1 (2010-05); EN 61508-2 (2010-05); EN 61508-3 (2010-05); EN 61508-4 (2010-05); EN 61508-5 (2010-05); EN 61508-6 (2010-05); EN 61508-7 (2010-05); EN 62304 (2006-07); EN ISO 534 (2011-11); EN ISO 4017 (2014-06); EN ISO 12100 (2010-11); EN ISO 13732-1 (2008-09); EN ISO 13849-2 (2012-10); EN ISO 17665-1 (2006-08); ISO 3781 (2011-09); ISO 8787 (1986-08); 98/83/EG (1998-11-03); 2006/42/EG (2006-05-17); ANSI/AAMI RD 47 (2020); EN 285+A1 (2021-10); EN ISO 20417 (2021-05); EN 1422 (2014-05); EN 1837 (2020-12); EN 10027-2 (2015-04); EN 13445-1 (2021-05); EN 13445-1 (2021-05); EN 13445-2 (2021-05); EN 13445-2 (2021-05); EN 13445-2 (2021-05); EN 13445-3 (2021-05); EN 13445-3 (2021-05); EN 13445-3 (2021-05); EN 13445-4 (2021-05); EN 13445-4 (2021-05); EN 13445-4 (2021-05); EN 13445-5 (2021-05); EN 13445-5 (2021-05); EN 13445-5 (2021-05); EN 13445-5 (2021-05); EN 13445-5 (2021-05); EN 13445-6 (2021-05); EN 13445-8 (2021-05); EN 60204-1 (2018-09); EN IEC 62061 (2021-07); EN ISO 536 (2020-02); EN ISO 2758 (2014-08); EN ISO 9000 (2015-09); EN ISO 13485 (2016-03); EN ISO 25424 (2019-11); ISO 1762 (2019-07); ISO 11139 (2018-08); EUV 2017/745 (2017-04-05); 2014/68/EU (2014-05-15)
  • Cited in:
    DIN 58948-7 (2017-03); DIN 58948-17 (2016-10)<STARR>; TRGS 513 Anlage 5 Änd (2017-09-11)<STARR>; VDI 5701 (2018-05)<STARR>; VDI 6300 Blatt 1 (2016-05)<STARR>
  • Identical with:
    EN 14180(2014-05)<IDT>; TS EN 14180(2015-09-11)<IDT>
  • Legislation:
    93/42/EWG (1993-06-14)<M>; Medizinprodukterichtlinie
  • Update flag:
    Unchanged