Chapter 2 Instrument Nomenclature and Specifications
20
Medical Devices
Directive
RoHS
Directive
EMC
Year of manufacture
Degree of protection
against electric
shock
Ingress protection
rating
ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF-UC180F
Applied standards;
IEC 60601-1-2: 2001
IEC 60601-2-37: 2001
1712345
IPX7
This device complies with the
requirements of Directive 93/42/EEC
concerning medical devices.
Classification: Class II a
This device complies with the
requirements of Directive
2011/65/EU concerning electrical
and electronic equipment.
This instrument complies with the
standards listed in the left column.
CISPR 11 of emission:
Group 1, Class B
This instrument complies with the
EMC standard for medical electrical
equipment; edition 2 (IEC 60601-1-2:
2001). However, when connecting to
an instrument that complies with the
EMC standard for medical electrical
equipment; edition 1 (IEC 60601-1-2:
1993), the whole system complies
with edition 1.
The last digit of the year of
manufacture is given in the second
digit of the serial number.
TYPE BF applied part
This instrument complies with the
standards for medical electrical
equipment: IEC 60601-1: 1988
IEC 60601-2-37: 2001.