
Medical electrical equipment Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems
出版:International Electrotechnical Committee

专家解读视频
Specifies the particular safety requirements for ambulatory electrocardiographic systems. Within the scope of this standard are systems of the following types: a) systems that provide continuous recording and continuous analysis of the ECG allowing full re-analysis giving essentially similar results. The systems may first record and store the ECG and analyse it later on a separate unit, or record and analyse the ECG simultaneously. The type of storage media used is irrelevant with regard to this standard; b) systems that provide continuous analysis and only partial or limited recording not allowing a full re-analysis of the ECG. The safety aspects of this standard apply to all types of systems falling in one of the above- mentioned categories.
AAMI EC38 Ed. 3 (2007) - Identical
AAMI EC38 Ed. 2 (1998) - Identical
SS EN 60601-2-47 Ed. 1 (2002) - Identical
CSA C22.2.60601.2.47:2003 (R2012) - Identical
UNE EN 60601-2-47:2002 - Identical
NBR IEC 60601-2-47:2003 - Identical
NF EN 60601 2-47:2005 - Identical
VDE 0750-2-47:2002 - Identical
CEI EN 60601-2-47 Ed. 1 (2003) - Identical
BS EN 60601-2-47:2001 - Equivalent
DIN EN 60601-2-47 (2002-11) - Identical
I.S. EN 60601-2-47:2002 - Identical
PN EN 60601-2-47:2002 - Identical
NEN EN IEC 60601-2-47:2001 - Identical