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The SENOGRAPHE DMR complies to the following regulations:
D UL 187 X-ray equipment
D CSA 22.2, No. 114 Radiation Emitting Equipment
D IEC 60601–1 Medical Electrical Equipment
Part 1: General requirements for safety
D IEC 60601–2–7 Medical Electrical Equipment
Part 2–7: Particular requirements for
the safety of high voltage generators
of diagnostic x-ray generators.
D 21 CFR, Part 1020.30, sub. J Code of Federal regulation
Performance standards for ionizing radiation
emitting products.
D EMC (Electromagnetic compatibility) as per IEC 60601–1–2 ed. 1–93:
D Emission:
1. CISPR11 class A: Electromagnetic disturbances.
D 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
1GHz).
3. IEC 60801–4: Electrical fast transient/burst (2 kV on power supply cables,
500V interconnection cables).
4. IEC 801–5: Shock waves: (2 kV common mode, 1 kV differential mode).
D CE marking according to council directive 93/42/EEC.
FOR TRAINING PURPOSES ONLY!
NOTE: Once downloaded, this document is UNCONTROLLED, and therefore may not be the latest revision. Always confirm revision status against a validated source (ie CDL).
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