GE SENOGRAPHE 800T

REGULATIONS
GE Medical Systems SENOGRAPHE 800T
REV 6 om 2135575–100
5–1
CHAPTER 5 – REGULATIONS
The SENOGRAPHE 800T complies to the following regulations:
 UL 187 X-ray equipment
 CSA 22.2, No. 114 Radiation Emitting Equipment
 IEC 601–1 Medical Electrical Equipment
Part 1: General requirements for safety
 IEC 601–2–7 Medical Electrical Equipment
Part 2: Particular requirements for the safety of high
voltage generators of diagnostic x-ray generators.
 21 CFR, Part 1020.30, sub. J Code of Federal regulation
Performance standards for ionizing radiation
emitting products.
 EMC (Electromagnetic compatibility):
– Emission:
– CISPR11 classA: Electromagnetic disturbances.
– Immunity:
– IEC 801–2: Electrostatic discharge (conducting parts: 3 kV, non-conducting
parts: 8 kV).
– IEC 801–3: Radiated electromagnetic field (3 V/m, from 26 MHz to 1 GHz).
– IEC 801–4: Electrical fast transient/burst (2 kV on power supply cables, 500 V
interconnection cables).
– IEC 801–5: Shock waves: (2 kV common mode, 1 kV differential mode).
 CE marking according to council directive 93/42/EEC.