Operation Manual

GMC-I Messtechnik GmbH 145
Appendix
10.5 Classification of Devices Under Test
10.5.1 Safety Classes
Devices assigned to all of the following safety classes are
equipped with basic insulation, and provide for protection against
electrical shock by means of various additional precautions as
well.
Safety Class I Devices
Exposed, conductive parts are connected to the protective
conductor so that they are not charged with voltage if the basic
insulation should fail.
Safety Class II Devices
These devices are equipped with double insulation or reinforced
insulation.
Safety Class III Devices
These devices are powered with safety extra-low voltage (SELV).
Beyond this, no voltages are generated which exceed SELV.
These devices may not be connected to the mains.
Note: Only visual inspection can be performed with the
test system.
10.5.2 Application Parts (electrical medical devices)
Type B Application Parts (body)
Devices of this type are suitable for both internal and external
patient applications, except for use in direct proximity to the heart.
These devices provide for adequate protection against shock,
especially as regards:
• Reliable leakage current
• Reliable protective conductor connection if utilized
The following safety classes are permissible: I or II
Type BF Application Parts (body float)
Same as type B, but with type F insulated application parts.
Type CF Application Parts (cardiac float)
Devices of this type are suitable for use directly at the heart. The
application part may not be grounded.
The following safety classes are permissible: I or II