Full display

  • Abstract:
    This standard specifies requirements that are applicable to those ACTIVE IMPLANTABLE MEDICAL DEVICES intended to treat bradyarrhythmias. The tests that are specified in EN 45502 are type tests, and are to be carried out on samples of a device to show compliance. This standard is also applicable to some non-implantable parts and accessories of the devices. The characteristics of the IMPLANTABLE PULSE GENERATOR or LEAD shall be determined by either theappropriate method detailed in this Part 2-1 or by any other method demonstrated to have an accuracy equal to, or better than, the method specified. In the case of dispute, the method detailed in this Part 2-1 shall apply.
  • Document number:
    DIN EN 45502-2-1; VDE 0750-10-1
  • Issuing date:
    2004-08-01
  • Document type:
    Norm
  • Title:
    Active implantable medical devices - Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers); German version EN 45502-2-1:2003
  • Replaces:
    DIN EN 45502-2-1(2004-02); DIN EN 50061/A1(1996-07); DIN VDE 0750-9(1992-08)
  • Author:
    German Commission for Electrical, Electronic and Information Technologies of DIN and VDE
  • Search term:
    Atmospheric pressure; Bend testing; Bradyarrhythmia; CE marking; Definitions; Disposables; Electrical engineering; Electrical medical equipment; Electricity; Electrodes; Electromagnetic radiation; Electromagnetism; Electromedicine; Electrostatic; Electrostatics; Frequencies; Graphic symbols; Implants (surgical); Input impedance; Inscription; Instruments; Interval; Ionizing; Marking; Measurement; Medical electronics; Medical sciences; Medical technology; Pacemakers; Packages; Perception; Performance tests; Pulse amplitude; Pulse durations; Pulse generators; Radiation; Ratings; Safety; Sensitivity; Specification (approval); Surgical implants; Symbols; Testing
  • Application areas:
    09.05 Medizinische Geräte und Instrumente
  • Hazards:
    AB Terminologische Festlegungen in Normen mit Arbeitsschutzbezug; AD Folgen von Belastungen und Gefährdungen (z. B. Ermüden, Ersticken, Ertrinken); EB Berühren spannungsführender oder leitfähiger Teile; GH Elektrische, magnetische und elektromagnetische Felder; GI Ionisierende Strahlungen (Röntgenstrahlungen, radioaktive Strahlung / Alpha-, Beta- und Gamma-Strahlung); HB Klima (Temperatur, Feuchtigkeit, Luftströmung, Luftzusammensetzung u. Ä.)
  • ICS:
    11.040.40 Implants for surgery, prosthetics and orthotics
  • Price:
    143,69 EUR
  • Cross references:
    EN 45502-2-2 (2008-03)<G>; ISO 11318 (2002-08)<G>; ANSI/AAMI/ISO 14117 (2019)<G>; EN 28601 (1992-11)<G>; EN 45502-1 (2015-05)<G>; EN 60068-2-27 (2009-05)<G>; EN 60068-2-47 (2005-06)<G>; EN 60068-2-47 (2005-06)<G>; EN 60068-2-64 (2008-09)<G>; ISO 5841-3 (2013-04)<G>
  • Cited in:
    DIN EN 45502-1 (2016-02); DIN EN 45502-2-2 (2008-10); DIN EN 45502-2-3 (2010-07); DIN EN 50500 (2009-03); DIN EN 50502 (2016-03); DIN EN 50527-1 (2011-01); DIN EN 50527-1 (2017-12); DIN EN 50527-2-1 (2012-05); DIN EN 50527-2-1 (2017-12); DIN EN 50527-2-2 (2019-11); DIN EN 60601-2-33 (2011-07); DIN EN 60601-2-33 (2017-11); BGI/GUV-I 5111 (2009-06); BGI/GUV-I 5111 (2012-03); VDE-AR-E 2750-10 (2010-09)<STARR>; VDI 5701 (2018-05)<STARR>; SSKHGÜEmpfBek (2014-02-25)<STARR>
  • Identical with:
    EN 45502-2-1(2003-12)<IDT>
  • Legislation:
    90/385/EWG (1990-06-20)<H>; Aktive implantierbare medizinische Geräte-Richtlinie; 90/385/EWGMitt 2004-07 (2004-07-08); 90/385/EWGMitt 2008-11 (2008-11-27); 90/385/EWGMitt 2009-07 (2009-07-15); 90/385/EWGMitt 2009-12 (2009-12-02); 90/385/EWGMitt 2011-01 (2011-01-18); 90/385/EWGMitt 2011-05 (2011-05-13); 90/385/EWGMitt 2011-08 (2011-08-19); 90/385/EWGMitt 2012-04 (2012-04-27); 90/385/EWGMitt 2012-08 (2012-08-30); 90/385/EWGMitt 2013-01 (2013-01-24); 90/385/EWGMitt 2015-01 (2015-01-16); 90/385/EWGMitt 2015-07 (2015-07-10); 90/385/EWGMitt 2016-05 (2016-05-13); 90/385/EWGMitt 2017-11 (2017-11-17); EUB 2020/438 (2020-03-24)
  • Update flag:
    Unchanged