Sdn/Acc System Safety; Compliance With Iec 60601-1-1 - Agilent Technologies 78581B Installation And Service Manual

SDN/ACC System Safety

Section 9: SDN/ACC System
Safety

Compliance with IEC 60601-1-1

Connecting the ACC to other medical and non-medical devices creates a
medical electrical system. Such systems must comply with IEC 60601-1-1,
the Collateral standard to the General Medical Safety standard (IEC
60601) that specifies medical electrical system safety requirements. This
standard was developed to address safety issues raised by the increasing
sophistication of medical systems, interfacing of medical equipment to
other devices, and migration of computers and laboratory instrumentation
into the patient care environment. This standard is primarily intended for
the systems integrator (installer) who creates the medical system.
The basic philosophy of this system safety standard is to assure that
connecting a medical device to any other device will not cause a safety
hazard for the patient, the operator, or their surroundings. That is, any
system as a whole, or any non-medical device in the patient care vicinity,
must provide the same level of safety as an individual medical device that
complies with 60601-1.
In practice, this means that the combined chassis leakage current of a
medical device and any directly interconnected device must be less than
500 µA (300 µA in the US). If the combined leakage current exceeds 500
µA, the system integrator is responsible for taking actions to reduce the
leakage current and bring the system into compliance. Manufacturers are
responsible for indicating in their product labeling appropriate steps for an
integrator to take to bring a system into compliance.
IEC 60601-1-1 specifically allows the use of equipment that complies with
IEC XXX (for example, IEC 60950 for computers or IEC 61010 for
laboratory equipment) in the patient care environment provided that the
chassis leakage current meets the medical specifications. Meeting these
specifications may require the use of a separating transformer. This
means, for example, that an IEC 60950 compliant device (for example, a
Vectra computer) may be placed next to a patient if it is powered through
a separating transformer.
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