Safety
1-5
1.3 Reference Literature
Medical Device Directive 93/42/EEC
IEC 60601-1:1988+A1:1991+A2:1995 or
EN 60601-1:1990+A1:1993+A2:1995+A13:1996,
Medical Electrical Equipment, Part 1: General Requirements for Safety
EN60601-1-1 or IEC60601-1-1, Medical Electrical Equipment- Part 1-1: General
Requirements for Safety - Collateral Standard: Safety Requirements for Medical
Electrical Systems
IEC60601-1-4, Medical Electrical Equipment- Part 1-4: General Requirements for
Safety - Collateral Standard: Programmable Electrical Medical Systems
IEC60601-2-49 Medical Electrical Equipment-Part 2-49: Particular Requirements for
the Safety of Multifunction Patient Monitoring Equipment
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