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GE Medical Systems
REV1
CHAPTER 5 - REGULATIONS
The SENOGRAPHE DMR complies to the following regulations:
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UL 187 X-ray equipment
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CSA 22.2, No. 114
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IEC 60601–1
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IEC 60601–2–7
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21 CFR, Part 1020.30, sub. J
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EMC (Electromagnetic compatibility) as per IEC 60601–1–2 ed. 1–93:
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Emission:
1. CISPR11 class A: Electromagnetic disturbances.
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Immunity
1. IEC 60801–2: Electrostatic discharge (conducting parts: 3 kV, non-conducting
parts: 8 kV).
2. IEC 60801–3: Radiated electromagnetic field (3 V/m, from 26 MHz to
1 GHz).
3. IEC 60801–4: Electrical fast transient/burst (2 kV on power supply cables,
500 V interconnection cables).
4. IEC 801–5: Shock waves: (2 kV common mode, 1 kV differential mode).
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CE marking according to council directive 93/42/EEC.
5-1
SENOGRAPHE DMR+
om 5128689-2-100
Radiation Emitting Equipment
Medical Electrical Equipment
Part 1: General requirements for safety
Medical Electrical Equipment
Part 2–7: Particular requirements for
the safety of high voltage generators
of diagnostic x-ray generators.
Code of Federal regulation
Performance standards for ionizing radiation
emitting products.
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