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Standard* Edition** Reference***
EN 1060-1/A1 1995 Non-invasive sphygmomanometers —
Part 1: General requirements.
EN 1060-3/A1 1997 Non-invasive sphygmomanometers —
Part 3: Supplementary requirements for electro-
mechanical blood pressure measuring systems.
EN 1060-4/A1 2004 Non-invasive sphygmomanometers - Part 4: Test
procedures to determine the overall system accuracy of
automated noninvasive sphygmomanometers
EN 60601-1/A2 1995 Medical electrical equipment – Part 1: General
requirements for basic safety and essential
performance.
EN 60601-1-2 2007 Medical electrical equipment – part 1-2: General
requirements for basic safety and essential
performance – Collateral standard: electromagnetic
compatibility – Requirements and tests
EN ISO 14971 2007 Medical devices – Application of risk
management to medical devices.
EN ISO 10993-1 2003 Biological evaluation of medical devices –
Part 1: Evaluation and Testing.
EN 1041 2008 Information supplied by the manufacturer
of medical devices.
EN 62304 2006 Medical device software – Software life-cycle processes
EN 980 2008 Symbols for use in labeling of medical devices
*Standard / Standard / Norma / Standardi / Norme / Πρότυπο / / Normativa / Standaard /
Standard / Padrão / Standard
** Ausgabe / Udgave / Edición / Versio / Edition / Έκδοση /
/ Edizione / Editie / Utgave /
Edição / Utgåva
*** Verweis / Reference / Referencia / Viittaus / Référence / Αναφορά /
/ Riferimento /
Referentie / Henvisning / Referência / Referens
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