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  • Abstract:
    This Standard gives requirements and test methods for evaluating the performance parameters of sharps injury protection features, whether active or passive in design, for medical devices containing (sharp) hypodermic needles for single use, introducers for catheters and lancets, and other needles used in blood sampling. The sharps injury protection devices it covers may be provided integral to the device or combined with the device prior to use to achieve the sharps injury protection. It does not give requirements for the storage and handling of the sharps protection before its intended use, or for the medical device itself.
  • Document number:
    DIN EN ISO 23908
  • Issuing date:
  • Document type:
  • Title:
    Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling (ISO 23908:2011); German version EN ISO 23908:2013
  • Replaces:
    DIN EN ISO 23908(2011-09); DIN EN ISO 23908(2013-04)
  • Author:
    Medical Standards Committee
  • Search term:
    Blood taking; Blood-taking set; Cannulas; Catheters; Data of the manufacturer; Definitions; Health protection; Infusions; Injections; Injuries; Instructions for use; Marking; Medical equipment; Medical instruments; Medical products; Medical sciences; Needles; Protection against piercing; Protection devices; Protective caps; Protective measures; Public health; Safety device; Sections; Specification (approval); Stitches; Surgical needles; Testing
  • 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; BB Mikroorganismen (Viren, Bakterien, Parasiten u. Ä.); DD Schneiden; DG Stoßen, Durchstoßen, Stechen, Durchstechen; HI Mangelhafte Gebrauchsanweisungen und Betriebsanleitungen
  • ICS:
    11.040.25 Syringes, needles and catheters
  • Price:
    90,40 EUR
  • Cross references:
    ISO 2859-1 (1999-11)<G>; ISO 2859-1 Technical Corrigendum 1 (2001-03)<G>; ISO 2859-3 (2005-05)<G>; ISO 2859-5 (2005-06)<G>; ISO 3951-3 (2007-05)<G>; ISO 3951-5 (2006-03)<G>; ISO 2859-2 (2020-02)<G>; ISO 2859-4 (2020-06)<G>; ISO 28590 (2017-10)<G>; ISO 3951-1 (2022-08)<G>; ISO 3951-2 (2013-09)<G>; ISO 3951-2 (2013-09)<G>; ISO 14971 (2019-12)<G>; ISO 16269-6 (2014-01)<G>; DIN EN 62366-1 (2021-08); DIN EN ISO 14971 (2022-04); DIN EN ISO 15223-1 (2022-02); DIN ISO 16269-6 (2009-10); ISO 15223-1 (2021-07); IEC 62366-1 (2015-02); EUV 2017/745 (2017-04-05)
  • Cited in:
    DIN EN ISO 3826-4 (2015-12); DIN EN ISO 7886-1 (2018-07); DIN EN ISO 7886-1 (2020-11); DIN EN ISO 7886-3 (2020-10); DIN EN ISO 8537 (2016-11); DIN EN ISO 11608-1 (2022-09); DIN EN ISO 22413 (2021-09); DIN ISO 11040-4 (2017-07); DIN ISO 11040-8 (2020-11); DGUV Information 207-024 (2015-11); DGUV Information 207-024 (2022-08)
  • Identical with:
    EN ISO 23908(2013-02)<IDT>; ISO 23908(2011-06)<IDT>
  • Update flag: