- Abstract:The second edition of IEC 60601-1-8 was published in 2006 and amended in 2012. Since the publication of IEC 60601-1-8:2006/AMD1:2012, the IEC Subcommittee (SC) 62A Secretariat has been collecting issues from a variety of sources including comments from National Committees. At the November 2015 meeting of IEC/SC 62A in Kobe, Japan, the subcommittee initiated a process to identify high-priority issues that need to be considered in Amendment 2 and should not wait until the Third Edition, which is presently targeted for publication sometime after 2024.
- Document number:DIN EN 60601-1-8; VDE 0750-1-8
- Issuing date:2021-12-01
- Document type:Norm
- Title:Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems (IEC 60601-1-8:2006 + A1:2012 + A2:2020); German Version EN 60601-1-8:2007 + Cor.:2010 + A1:2013 + A1:2013/AC:2014 + A11:2017 + A2:2021
- Replaces:DIN EN 60601-1-8(2014-04); DIN EN 60601-1-8/A2(2018-09); DIN EN 60601-1-8/A11(2018-02)
- Author:German Commission for Electrical, Electronic and Information Technologies of DIN and VDE
- Search term:Acoustic; Alarm signals; Alarm systems; CE marking; Characteristics; Definitions; Electric appliances; Electrical appliances; Electrical engineering; Electrical medical equipment; Electromedicine; Equipment; Features; Graphic symbols; Indicator lamps; Instructions for use; Letterings; Marking; Medical equipment; Medical sciences; Medical technology; Optical; Safety; Safety devices; Safety requirements; Signals; Specification (approval); Testing
- Application areas:09.05 Medizinische Geräte und Instrumente
- Hazards:AB Terminologische Festlegungen in Normen mit Arbeitsschutzbezug; EA Elektrische Gefährdungen im Allgemeinen
- ICS:11.040.55 Diagnostic equipment
- Price:190,37 EUR
- Cross references:IEC 60601-1 (2005-12)<S>; IEC 60601-1 AMD 1 (2012-07)<S>; IEC 60601-1 AMD 2 (2020-08)<S>; IEC 61672-1 (2013-09)<S>; IEC 62366-1 (2015-02)<S>; ISO 3744 (2010-10)<S>; IEC 62366-1 AMD 1 (2020-06)<S>; IEC 60417-DB (2002-10)<G>; ISO 7000 (2019-07)<G>; DIN IEC/TR 80001-2-5 (2016-03); DIN EN 61672-1 (2014-07); DIN EN 62366-1 (2021-08); DIN EN ISO 3744 (2011-02); DIN EN ISO 9000 (2015-11); DIN EN ISO 11073-10201 (2020-09); DIN ISO 7000 (2008-12); DIN VDE 0752 Beiblatt 1 (2003-03); EN 60601-1-8 (2007-07); IEC/TR3 60513 (1994-01); ISO 8201 (2017-11); ISO 9000 (2015-09); ISO 11428 (1996-12); ISO 11429 (1996-12); DIN EN 842 (2009-01); DIN EN 60601-1 (2022-11); DIN EN IEC 80001-1 (2023-02); DIN EN ISO 14971 (2022-04); ANSI/AAMI HE 48 (2001); IEC 62366-1 (2015-02); IEC 80001-1 (2021-09); ISO 9703-2 (1994-11); ISO/IEEE 11073-10201 (2020-04); ISO 14971 (2019-12); EUV 2017/745 (2017-04-05)
- Cited in:DIN EN 60335-2-15 (2022-05); DIN EN IEC 60335-2-76 (2023-02); DIN EN IEC 60335-2-90 (2023-03); DIN EN IEC 60335-2-110 (2022-08); DIN EN 60601-1 (2022-11); DIN EN 60601-1-12 (2022-02); DIN EN IEC 60601-2-19 (2022-08); DIN EN IEC 60601-2-21 (2022-11); DIN EN IEC 60601-2-35 (2022-10); DIN EN IEC 60601-2-50 (2022-08); DIN EN 60601-2-63 (2022-08); DIN EN 60601-2-65 (2022-07); DIN EN 60825-1 (2022-07); DIN EN 62841-1 (2023-03); DIN EN IEC 80601-2-26 (2022-04); DIN EN ISO 11608-1 (2022-09); DIN EN ISO 11608-4 (2022-09); DIN EN ISO 14708-5 (2022-12)
- Identical with:EN 60601-1-8(2007-07)<IDT>; EN 60601-1-8/AC(2010-03)<IDT>; EN 60601-1-8/A1(2013-03)<IDT>; EN 60601-1-8/A1/AC(2014-05)<IDT>; EN 60601-1-8/A2(2021-07)<IDT>; EN 60601-1-8/A11(2017-03)<IDT>; IEC 60601-1-8(2006-10)<IDT>; IEC 60601-1-8 AMD 1(2012-11)<IDT>; IEC 60601-1-8 AMD 2(2020-07)<IDT>
- Legislation:93/42/EWG (1993-06-14)<H>; Medizinprodukterichtlinie; 93/42/EWGMitt 2008-11 (2008-11-27); 93/42/EWGMitt 2009-07 (2009-07-15); 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)
- Update flag:Unchanged