Standard*
EN 1060-1/A1
EN 1060-3/A1
EN 1060-4/A1
EN 60601-1/A2
EN 60601-1-2
EN ISO 14971
EN ISO 10993-1
EN 1041
EN 62304
EN 980
*Standard / Standard / Norma / Standardi / Norme / Πρότυπο /
Standard / Padrão / Standard
** Ausgabe / Udgave / Edición / Versio / Edition / Έκδοση /
Edição / Utgåva
*** Verweis / Reference / Referencia / Viittaus / Référence / Αναφορά /
Referentie / Henvisning / Referência / Referens
Edition**
Reference***
1995
Non-invasive sphygmomanometers —
Part 1: General requirements.
1997
Non-invasive sphygmomanometers —
Part 3: Supplementary requirements for electro-
mechanical blood pressure measuring systems.
2004
Non-invasive sphygmomanometers - Part 4: Test
procedures to determine the overall system accuracy of
automated noninvasive sphygmomanometers
1995
Medical electrical equipment – Part 1: General
requirements for basic safety and essential
performance.
2007
Medical electrical equipment – part 1-2: General
requirements for basic safety and essential
performance – Collateral standard: electromagnetic
compatibility – Requirements and tests
2007
Medical devices – Application of risk
management to medical devices.
2003
Biological evaluation of medical devices –
Part 1: Evaluation and Testing.
2008
Information supplied by the manufacturer
of medical devices.
2006
Medical device software – Software life-cycle processes
2008
Symbols for use in labeling of medical devices
/ Normativa / Standaard /
/ Edizione / Editie / Utgave /
154
/ Riferimento /