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  • Abstract:
    This International Standard specifies certain requirements for HMEs, including those incorporating breathing system filters, intended for the humidification of respired gases for use with patients with a tidal volume equal to or greater than 250 ml, and describes test methods for their evaluation.
  • Document number:
    DIN EN ISO 9360-1
  • Issuing date:
    2009-09-01
  • Document type:
    Norm
  • Title:
    Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying respired gases in humans - Part 1: HMEs for use with minimum tidal volumes of 250 ml (ISO 9360-1:2000); German version EN ISO 9360-1:2009
  • Replaces:
    DIN EN ISO 9360-1(2000-04); DIN EN ISO 9360-1/A1(2009-02)
  • Author:
    Rescue Services and Hospital Standards Committee
  • Search term:
    Air exchange; Anaesthesiology; Biological hazards; Bodies; Breathing equipment; CE marking; Conditions; Connecting pieces; Definitions; Determination of moisture; Exchangers; Flows; Gases; Head losses; Heat; Heat exchange; Heat exchangers; Information; Inhaled air; Inscription; Jigs; Leakage; Losses; Measurement; Measuring techniques; Medical equipment; Moisture; Moisture control; Openings; Operational instructions; Patients; People; Product information; Recommendation; Respired gases; Safety; Safety requirements; Sellers; Sensors; Specification (approval); Symbols; Test equipment; Testing; Volume; Wetting
  • Application areas:
    09.05 Medizinische Geräte und Instrumente
  • 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.); HF Mangelhafte Kennzeichnungen
  • ICS:
    11.040.10 Anaesthetic, respiratory and reanimation equipment
  • Price:
    110,80 EUR
  • Cross references:
    IEC 60601-1 (1988){historisch}<S>; ISO 4135 (1995-07){historisch}<S>; ISO 5356-1 (1987-06){historisch}<S>; ISO 5356-2 (1987-07){historisch}<S>; ISO 7000 (1989-11){historisch}<S>; ISO 11607-2 (2019-02)<G>
  • Cited in:
    DIN EN ISO 10651-2 (2011-06); DIN EN ISO 80601-2-12 (2012-02); DIN EN ISO 80601-2-12 (2020-07); DIN EN ISO 80601-2-72 (2016-04); DIN EN ISO 80601-2-74 (2020-07); DIN EN ISO 80601-2-74 (2022-01); DIN EN ISO 80601-2-79 (2020-02); DIN EN ISO 80601-2-80 (2020-02)
  • Identical with:
    EN ISO 9360-1(2009-04)<IDT>; ISO 9360-1(2000-03)<IDT>; TS EN ISO 9360-1(2010-03-23)<IDT>
  • Legislation:
    93/42/EWG (1993-06-14)<H>; Medizinprodukterichtlinie; 93/42/EWGMitt 2009-12 (2009-12-02); 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