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  • Abstract:
    This part of EN 455 specifies requirements for the evaluation of biological safety for medical gloves for single use. It gives requirements for labelling and the disclosure of information relevant to the test methods used.
  • Document number:
    DIN EN 455-3
  • Issuing date:
    2015-07-01
  • Document type:
    Norm
  • Title:
    Medical gloves for single use - Part 3: Requirements and testing for biological evaluation; German version EN 455-3:2015
  • Replaces:
    DIN EN 455-3(2007-03); DIN EN 455-3(2013-06)
  • Author:
    Medical Standards Committee
  • Search term:
    Allergenic; Allergens; Biocompatibility; Biological; Biological characteristics; Biological hazards; Biological tests; Chemical analysis and testing; Chemicals; Definitions; Determination; Disposable; Disposables; Evaluations; Examination gloves; Gloves; HPLC; Latices; Marking; Medical; Medical devices; Medical equipment; Medical products; Medical sciences; Methods of analysis; Physical properties; Properties; Protective clothing; Protective gloves; Protective measures; Proteins; Risk analysis; Rubber; Safety; Skin contact; Specification (approval); Surgical gloves; Testing; Throw-away clothes; Warning notices; Water soluble
  • 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; BB Mikroorganismen (Viren, Bakterien, Parasiten u. Ä.); BD Allergene; CA Chemische Gefährdungen im Allgemeinen
  • ICS:
    11.140 Hospital equipment
  • Price:
    125,60 EUR
  • Cross references:
    EN 1041+A1 (2013-09){historisch}<S>; EN ISO 10993-1 (2009-10){historisch}<S>; EN ISO 10993-5 (2009-06)<S>; EN ISO 10993-10 (2013-08)<S>; EN ISO 14971 (2012-07){historisch}<S>; EN ISO 15223-1 (2012-07){historisch}<S>; EN ISO 21171 (2006-05)<S>; EUV 2017/745 (2017-04-05)
  • Cited in:
    DIN 13155 (2016-03)<GLEITEND>; DIN 13155 (2018-11)<GLEITEND>; DIN 13157 (2021-11)<GLEITEND>; DIN 13169 (2021-11)<GLEITEND>; DIN 14142 (2018-03)<GLEITEND>; DIN 14142 (2018-09)<GLEITEND>; DIN 14530-8 (2010-08)<GLEITEND>; DGUV Grundsatz 304-001 (2016-09); DGUV Grundsatz 304-001 (2019-03); DGUV Grundsatz 304-002 (2016-09); DGUV Grundsatz 304-002 (2020-03); TRBA 250 Änd 2018-05 (2018-05-02); TRBA 255 (2021-02-05)<STARR>; TRBA 260 (2017-12-14); GesundhHygieneHändeEmpf (2016-09)<STARR>; InfektionsprävKrankheitEmpf (2015-10)<STARR>
  • Identical with:
    EN 455-3(2015-04)<IDT>
  • Update flag:
    Unchanged