Bionet BM5 - CE Standard Information

Rev. 3.1 1.BASIC
9
BM5 (CS,CX) User’s Manual
1.1 CE Standard Information
Electromechanical safety standards met:
- EN 60601-1: 1990 + A1:1993 + A2: 1995 + A13:1996 Medical Electrical Equipment, Part 1,
General Requirements for Safety.
- IEC/EN 60601-1-2 :2001 Electromagnetic compatibility -Requirements and tests.
- EN 1060-1:1995 Non-invasive sphygmomanometers - Part 1: General requirements
- EN 1060-3:1997 Non-invasive sphygmomanometers - Part 3: Supplementary requirements for
electro-mechanical blood pressure measuring systems
- EN ISO 9919:2005 Medical electrical equipment - Particular requirements for the basic safety and
essential performance
of pulse oximeter equipment for medical use (ISO 9919:2005)
- EN 60601-2-27:2006 Medical electrical equipment - Part 2-27: Particular requirements for the
safety, including essential performance,
of electrocardiographic monitoring equipment
- EN 60601-2-30:2000 Medical electrical equipment - Part 2-30: Particular requirements for the
safety, including essential performance,
of automatic cycling non-invasive blood pressure monitoring equipment
- EN 60601-2-34:2000 Medical electrical equipment - Part 2: Particular requirements for the safety,
including essential performance, of invasive blood pressure monitoring equipment
- EN 12470-4:2001 Clinical thermometers - Part 4: Performance of electrical thermometers for
continuous measurement
- EN 60601-2-49:2001 Medical electrical equipment - Part 2-49: Particular requirements for the
safety of multifunction patient monitoring equipment