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  • Abstract:
    This part of EN 455 specifies requirements for shelf life claims for medical gloves for single use. It also specifies the requirements for labelling and the disclosure of information relevant to the test methods used. This standard applies to existing, new and significantly changed designs. Existing designs that do not currently have ageing data available shall generate that data within a reasonable period of time.
  • Document number:
    DIN EN 455-4
  • Issuing date:
    2009-10-01
  • Document type:
    Norm
  • Title:
    Medical gloves for single use - Part 4: Requirements and testing for shelf life determination; German version EN 455-4:2009
  • Replaces:
    DIN EN 455-4(2007-05)
  • Author:
    DIN Standards Committee Health Technologies
  • Search term:
    Ageing (materials); CE marking; Definitions; Disposable; Disposable gloves; Disposables; Durability; Gloves; Latices; Marking; Medical devices; Medical equipment; Medical sciences; Occupational safety; Polyvinyl chloride; Protective clothing; Protective gloves; Specification (approval); Surgical gloves; Testing
  • Application areas:
    09.10 Medizinische Produkte; 30.35 Hand- und Armschutz
  • Hazards:
    AB Terminologische Festlegungen in Normen mit Arbeitsschutzbezug; AC Mess- und Prüfverfahren für die Ermittlung von Belastungen und Gefährdungen; BA Biologische Gefährdungen im Allgemeinen; CA Chemische Gefährdungen im Allgemeinen
  • ICS:
    11.140 Hospital equipment
  • Price:
    99,10 EUR
  • Cross references:
    ; EN 455-1+A1 (2022-02)<G>; EN 455-2 (2015-04)<G>; EN 455-3 (2015-04)<G>; EN ISO 20417 (2021-05)<G>; EN ISO 11607-1 (2020-01)<G>; EN ISO 11607-2 (2020-01)<G>; EN ISO 291 (2008-05); EN ISO 2578 (1998-08); ISO 11346 (2014-12); EUV 2017/745 (2017-04-05)
  • Cited in:
    DIN 13155 (2016-03)<GLEITEND>; DIN 13155 (2018-11)<GLEITEND>; DIN 13157 (2009-11)<GLEITEND>; DIN 13164 (2014-01)<GLEITEND>; DIN 13167 (2014-01)<GLEITEND>; DIN 13169 (2009-11)<GLEITEND>; DIN 13232 (2011-05)<GLEITEND>; DIN 14142 (2018-03)<GLEITEND>; DIN 14142 (2018-09)<GLEITEND>; DIN 14530-8 (2010-08)<GLEITEND>; DIN 14530-8 (2012-09)<GLEITEND>; DIN 14530-24 (2012-09)<GLEITEND>; DIN 14530-25 (2012-09)<GLEITEND>; DIN 23405 (2012-09)<GLEITEND>; DIN 75079 (2009-11)<GLEITEND>; BGI/GUV-I 509 (2009-12); BGI/GUV-I 509 (2013-07); DGUV Grundsatz 304-001 (2015-02); DGUV Grundsatz 304-001 (2016-09); DGUV Grundsatz 304-001 (2019-03); DGUV Grundsatz 304-001 (2022-04); DGUV Grundsatz 304-002 (2016-09); DGUV Grundsatz 304-002 (2020-03); DGUV Grundsatz 304-002 (2022-04); DGUV Information 207-007 (2022-03); DGfdB R 94.13 (2011-08)<GLEITEND>; BGI/GUV-I 8584 (2010-03); BGI/GUV-I 8584 (2012-10); TRBA 240 (2010-12-06); TRBA 250 (2014-03-27); TRBA 250 Änd 2018-05 (2018-05-02); TRBA 260 (2017-12-14); GesundhHygieneHändeEmpf (2016-09)<STARR>
  • Identical with:
    EN 455-4(2009-07)<IDT>; TS EN 455-4(2014-10-30)<IDT>
  • Legislation:
    93/42/EWG (1993-06-14)<H>; Medizinprodukterichtlinie; 93/42/EWGMitt 2010-07 (2010-07-07); 93/42/EWGMitt 2011-01 (2011-01-18); 93/42/EWGMitt 2011-05 (2011-05-13); 93/42/EWGMitt 2011-08 (2011-08-19); 93/42/EWGMitt 2012-04 (2012-04-27); 93/42/EWGMitt 2012-08 (2012-08-30); 93/42/EWGMitt 2013-01 (2013-01-24); 93/42/EWGMitt 2014-05 (2014-05-16); 93/42/EWGMitt 2015-01 (2015-01-16); 93/42/EWGMitt 2015-07 (2015-07-10); 93/42/EWGMitt 2016-05 (2016-05-13); 93/42/EWGMitt 2017-11 (2017-11-17); EUB 2020/437 (2020-03-24)
  • Update flag:
    Unchanged

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