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  • Abstract:
    This European Standard specifies the performance requirements for a Class B indicator to be used as an alternative to the Bowie and Dick test for steam sterilizers for wrapped goods (instruments etc. and porous loads). An indicator complying with this European Standard incorporates a specified material which is used as a test load. This test load may, or may not, be re-usable.
  • Document number:
    DIN EN ISO 11140-4
  • Issuing date:
    2007-07-01
  • Document type:
    Norm
  • Title:
    Sterilization of health care products - Chemical indicators - Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration (ISO 11140-4:2007); German version EN ISO 11140-4:2007
  • Replaces:
    DIN EN 867-4(2001-02); DIN EN ISO 11140-4(2005-12)
  • Author:
    Medical Standards Committee
  • Search term:
    Aeration; Ageing (materials); Air; Biological hazards; Bodies; Bowie and Dick test; Calibration; Checking equipment; Chemical indicators; Classification systems; Conditions; Control; Control charts; Cycle; Defects; Definitions; Density; Determinations; Distance; Equipment; Geometry; Health protection; Heat; Indications; Indicators; Information; Leakage; Lighting systems; Limits (mathematics); Low pressure; Marking; Measurement; Measuring instruments; Medical devices; Medical products; Medical sciences; Medical technology; Methods; Non-biological; Optics; Packages; Penetrations; Performance; Personal health; Process; Product information; Quality assurance; References; Reflection; Sensitivity; Sensors; Sequence of operations; Signals; Specification; Specification (approval); Standards; Statistics; Steam sterilization; Steam sterilizers; Sterilization (hygiene); Sterilizers; Supply; Surveillance (approval); Systems; Test cycle; Testing; Testing conditions; Tracer methods; Use; Vapours; Verification; Wavelengths
  • 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; GL Kontakt mit heißen oder kalten Medien (Oberflächen, Umgebungen)
  • ICS:
    11.080.20 Disinfectants and antiseptics
  • Price:
    131,80 EUR
  • Cross references:
    EN 285 (2006-05){historisch}<S>; IEC 60584-2 (1982){historisch}<S>; IEC 60584-2 AMD 1 (1989-06){historisch}<S>; IEC 60751 (1983){historisch}<S>; IEC 60751 AMD 1 (1986){historisch}<S>; ISO 5-4 (1995-05){historisch}<S>; ISO 187 (1990-12)<S>; ISO/CIE 10526 (1991-12){historisch}<S>; ISO 11140-1 (2005-07){historisch}<S>; ISO 2248 (1985-12)<G>; ISO 5-1 (2009-12)<G>; ISO 5-3 (2009-12)<G>; DIN EN 20187 (1993-11); DIN EN 22248 (1993-02); DIN EN ISO 10012 (2004-03); DIN EN ISO 17665-1 (2006-11); DIN EN ISO 9001 (2015-11); DIN EN ISO 11140-1 (2015-03); DIN EN ISO 11140-3 (2009-09); DIN EN ISO 15882 (2008-12); DIN IEC 60584-2 (1992-06); DIN EN 60751 (2009-05)
  • Cited in:
    DIN 58921 (2011-01)<STARR>; DIN 58946-7 (2014-01)<GLEITEND>; DIN EN ISO 11139 (2019-05); DIN EN ISO 11140-1 (2015-03); DIN EN ISO 14534 (2011-06); DIN EN ISO 14534 (2015-08); DIN EN ISO 15882 (2008-12); DIN EN ISO 18472 (2018-11); DIN ISO 11040-4 (2017-07); DIN ISO 11040-7 (2020-11); DIN ISO/TS 17665-2 (2009-07); DIN ISO 21881 (2020-12); DIN ISO 21882 (2020-12); VDI 6300 Blatt 1 (2016-05)<STARR>
  • Identical with:
    EN ISO 11140-4(2007-03)<IDT>; ISO 11140-4(2007-03)<IDT>
  • Update flag:
    Unchanged