for High Quality Equipment
Medical Application Guide
The products described as“For Medical Devices”in this catalog are intended for use in the medical
devices classified as GHTF Classes A to C (Japan Classes I to III) except for all medical devices classified
as GHTF Class D (Japan Class IV) and implantable medical devices (bone-anchored hearing aid, artificial
retina system, and external unit which is connected to internal unit which is implanted in a body, etc.).
Therefore, when using our products for these medical devices, please check it carefully by referring to the
part number or the individual product specification sheets and use the corresponding products. Should
you have any questions on this matter, please contact us.
APPLICATION GUIDE
Risk Level
Classification according to the PMD Act of Japan
(based on the GHTF Rules)
Low
General
Medical Devices
(GHTF Class A)
Medical devices with
extremely low risk to the
human body in case of
problems
[Ex.]
High
Class I
Controlled
Medical Devices
(GHTF Class B)
Medical devices with
relatively low risk to the
human body in case of
problems
[Ex.]
・Electronic Thermometer
Gauge
Class II
Specially-controlled
Medical Devices
(GHTF Class C)
Medical devices with
relatively high risk to the
human body in case of
problems
[Ex.]
・Dialysis Machine
Class III
Specially-controlled
Medical Devices
(GHTF Class D)
Medical devices highly
invasive to patients and
case of problems
Class IV
MEDICAL APPLICATION GUIDE
with life-threatening risk in
[Ex.]
・Cardiac Pacemaker
Japan
・In Vitro Diagnostic Devices
・Nebulizer
・Blood Gas Analyzer
・Plethysmographs
・Electronic Blood Pressure
・Electronic Endoscope
・Breathing Sensor
・Hearing Aid
・
AC-powered Operating Table ・Electrocardiograph
・Surgical Light
・MRI
・Radiation Therapy Equipment ・Video Flexible Angioscope
・Implantable Infusion Pump
・Infusion Pump
・Cardiac Electrosurgical Unit
・Respirator
・Glucose Monitoring System
・AED (Automated External
・Inspection Device with
Cardiac Catheter
・Defibrillator, etc.
Defibrillator)
・Cholesterol Analysis Device ・Ultrasonic Diagnostic System ・Skin Laser Scanner
・Blood Type Analysis Device, ・
Diagnostic Imaging Equipment ・Electric Surgical Unit
etc.
・X-ray Diagnostic Equipment ・Insulin Pump, etc.
・Central Monitor
・Pulse Oximeter, etc.
FDA Classification
General Controls
Class I
General Controls and
Special Controls
of causing injury or harm to the
Class II
General Controls and
Premarket Approval
Medical devices with the possibility
of causing serious injury, disability
or death to the patient or user if a
defect or malfunction occurs in such
medical devices
Class III
U.S.A.
Medical devices without the possibility Medical devices with the possibility
of causing serious injury or harm
to the patient or user even if there
is a defect or malfunction in such
medical devices
patient or user if there is a defect or
malfunction in such medical devices
Coverage of
those Classes by
TAIYO YUDEN
Products
Product Series for Medical Devices
*Note: It is prohibited that our products are used in some medical devices such as
implantable medical devices even if such medical devices are classified as GHTF
Class C (Japan Class III).
N/A
▶ This catalog contains the typical specification only due to the limitation of space. When you consider the purchase of our products, please check our product specification sheets.
For details of each product (characteristics graph, reliability information, precautions for use, and so on), see our website (http://www.ty-top.com/) .
20
17
YUDEN [ TAIYO YUDEN ]
