Operation Manual
6 GMC-I Messtechnik GmbH
Applications and Classification of Devices Under Test
1.1 Classification of Devices Under Test
1.1.1 Protection Classes
Devices assigned to all of the following protection classes are
equipped with basic insulation, and provide for protection against
electrical shock by means of various additional precautions as well.
Protection 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.
Protection Class II Devices
These devices are equipped with double insulation or reinforced
insulation.
Protection 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 a visual inspection can be conducted for devices of this
protection class with the SECULIFE⏐SR.
1.1.2 Applied Parts (electrical medical devices)
Type B Applied 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
Type BF Applied Parts (body float)
Same as type B, but with type F insulated applied parts.
Type CF Applied Parts (cardiac float)
Devices of this type are suitable for use directly at the heart. The
application part may not be grounded.