Biomedical
Instrumentation
Winter 1393 Bonab University
Course information
Prerequisites:
• Electronic Measurements
Recommended Books and Notes:
Intro
• J.G. Webster, “Medical Instrumentation Application and Design”, John Wiley & Sons, 2010
• J. Aston, “Principles of Biomedical Instrumentation and Measurement”, Merrill Publishing
Company, 1990. • J.D. Enderle, J.D.Bronzino, “Introduction to Biomedical Engineering”, Wiley, 3 ^{r}^{d} Ed. 2008
Tentative Grading:
• Project (including inclass presentation) 
35% 

• Oral Presentation in class 
20% 

• Review paper (23 pages, IEEE conference format) 15% 

• Final Exam 
65% 
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The main Course book
Intro
About John G Webster’s book
Intro
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ترازو بوصم لصفرس
Intro
Examples: Cochlear Implant
Intro
• A surgically implanted electronic device that provides a sense of sound to a person who is profoundly deaf
• The quality of sound is different from natural hearing, with less sound information
• Each sensory fiber of the cochlear nerve handles a specific frequency (electively sensitive to a very narrow
frequency band)
stimulate all fibers
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Examples: Advances in Vision (Retinal Stimulation)
Intro
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Examples: Mini Gastric Imaging
Intro
• It is considered to be a very safe method to determine an unknown cause of a gastrointestinal bleed
• to examine parts of the gastrointestinal tract that cannot be seen with other types of endoscopy
• capsule usually passes through feces within 24–48 hours
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A success story: The AutoAnalyzer (Technicon, 35 years)
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• New medical instrument: inventionprototypedevelopmentclinical testing regulatory approvalmanufacturingmarketingsale of new instrument…
• An automated analyzer using a flow technique called continuous flow analysis (CFA)
• The design is based on separating a continuously flowing stream with air bubbles
• A continuous stream of material is divided by air bubbles into discrete segments in
which chemical reactions occur
• Was used: determine levels of albumin, alkaline phosphatase, blood urea nitrogen, bilirubin, calcium, cholesterol,… but now is replaced by discrete systems
•
Now mainly in industrial processes: Water, soil extracts
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Generalized Medical instrumentation system
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Control
feedback
Primary 
Sensing 
element 
Calibration
signal
Radiation, 
electric current, 
or other applied energy 
storage
Data
transmission
Figure 1.1 The sensor converts energy or information from the measurand to another form (usually electric). This signal is then processed and displayed so that humans can perceive the information. Elements and connections shown by dashed lines are optional for some applications.
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Measurand (quantity the system measures): Physical quantity
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• Displacement (velocity, acceleration, force)
• Impedance
• Temperature
• Chemical Concentration
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Sensor and Transducer
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• Minimize the energy extracted
• Minimally invasive
pressure
displacement
electric voltage
Strain gage
diaphragm
Pulse Oximetry
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Signal Conditioning
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• Impedance matching
• Analog/Digital for signal processing
• Signal form (time and frequency domains)
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Output Display
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• Numerical
• Graphical
• Discrete or continuous
• Visual
• Hearing
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Auxiliary Element
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• Adjust sensor and signal conditioning
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1.3 Alternative Operational Modes
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• Direct Mode: Measurand is readily accessible
• Temperature
• Heart Beat
• Indirect Mode: desired measurand is measured by measuring accessible measurand.
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• Morphology of internal organ: Xray shadows
• Volume of blood pumped per minute by the heart: respiration and blood gas concentration
• Pulmonary volumes: variation in thoracic impedance
(Breathing out = Low impedance)
1.3 Sampling and Continuous Modes
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• Sampling and collecting data will depend on the following:
• The rate of change in the measurand (temp., ion concentration = slow
sampling
vs. ECG or respiratory gas continuous)
• Condition of the patient
• Generating and Modulating Sensors
• Generating sensors produce their outputs from energy taken from
measurand (Photovoltaic cell)
• Modulating Sensors uses the measurand to alter the flow of energy from an external source (Photoconductive cell)
• Analog and Digital Modes
• RealTime and DelayedTime Modes
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1.4 Medical Measurement Constraints
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• Magnitude and frequency range of medical measurand are very low
• Proper measurandsensor interface cannot be obtained (without damage)
• Medical variables are seldom deterministic
• External energy must be minimized to avoid any damage
• Equipment must be reliable
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Ballistocardiograph
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A person lies down on a flat board set on rollers. A laser beam is directed at a tiny mirror positioned on one of the rollers. The laser beam is projected onto the ceiling or wall. The beating of the person's heart causes a slight movement in the body as indicated by the laser. This upward movement of the body is due to the 3rd Law reaction force of the blood being pumped to the lower body. The left ventricle of the heart squeezes blood upward into the aorta shown below. At the peak of the contraction, about 80 grams of blood is moving upward at 30 cm/s. The aorta does a Uturn forcing most of the blood to flow down to the lower body. The aorta and body force the blood down and in turn the body is forced up. The amount is too small to be seen by eye but can be seen when "amplified" by the lasermirror arrangement used in the demonstration. It can also be seen when standing quietly on a weight scale if the scale is sensitive enough and the vibration is not damped by the scale mechanism. Your weight decreases slightly when the blood slams into the top of the aorta.
1.5 Classification of Medical Instrument
• Quantity that is sensed
• pressure, flow, temp
• Principle of transduction
resistive, capacitive, electrochemical, ultrasound
•
• Organ system
• Cardiovascular
• Pulmonary
• Nervous
• Medicine specialties
•
pediatrics, cardiology, radiology
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1.6 Interfering and Modifying Inputs
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performance of the instrument itself.
Effect of a burst or ESD (Electrostatic discharge) disturbance on an electronic board.
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1.7 Compensation Techniques
To eliminate interfering and modifying input:
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1.Alter the design of essential instrument components to be less sensitive to
interference. (preferred) 2.Adding new components designed to offset the undesired inputs.
The four electromagnetic
interference (EMI)
coupling modes
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1.7 Compensation Techniques
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•Inherent Insensitive (twist electrode wires in ECG)
•Negative Feedback to minimize G _{d} which is effected by the modifying inputs
• ( x _{d} – H _{f} y ) G _{d} = y 
(1.1) 
• x _{d} G _{d} = y (1 + H _{f} G _{d} ) 
(1.2) 
•
y
G
d
1 H G
f
d
(1.3)
•Signal Filtering (electric, mechanical, magnetic)
• At the input, output, inside the device (many designers use nonelectric at input)
•Opposing Inputs (additional interfering inputs to cancel undesired)
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Compensation Techniques Example
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• Solution: (say, for when gain decreases by 20%)
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• Use a thermistor (temperature dependent resistor)
• Adjust characteristics of active system elements (say, amplification factor)
1.8 Biostatistics
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Medical Research Studies
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•  Observational: Characteristics of patients are observed and recorded
 Caseseries: describe characteristic of group
 Casecontrol: observe group that have some disease
 Crosssectional: Analyze characteristics of patients (1 particular time)
 Cohort: determine if a particular characteristic is a precursor for a disease.
 Experimental Intervention: Effect of a medical procedure or treatment is investigated
 Controlled: Comparing outcomes to drug and placebo
 Uncontrolled: No placebo and no comparison
 Concurrent controls: patient are selected the same way and for the same time.
 Doubleblind: Patients random to treatments and investigator does not know which
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Statistical Measurements
• Measures of the mean and central tendency
 Mean
X
i
X
n
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 Median: Middle value (used for skewed data)
 Mode: is the observation that occurs most frequently
 Geometric Mean: used with data on a logarithmic scale
GM
X X X
1
2
3
X
n
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Statistical Measurements
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Measure of spread or dispersion of data
• Range: Difference between the largest
and smallest observation
• Standard deviation: is a measure of the
spread of data about the mean
s
• For symmetric distribution 75% of the data lies between (mean  2s) and (mean + 2s)
• Coefficient of variation: standardize the variation to compare data measured in different scales.
s 100%
X
CV
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Statistical Measurements
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Methods for inference
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are used to estimate specific parameters such as the mean and the variance.
• Hypothesis testing and Pvalue:
reveals whether the sample gives enough evidence for us to reject the null hypothesis. Pvalue indicates how often
the observed difference would occur by chance alone.
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Methods for measuring the accuracy of a diagnostic procedure
• Sensitivity of a test:
Probability of its yielding positive results in patients who actually
have the disease.
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• Specificity of a test:
Probability of its yielding negative results in patients who do not have the disease
• Prior Probability:
the prevalence of the condition prior to the test.
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Characteristics of Instrument Performance
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• Two classes of characteristics are used to evaluated and compare
new instrument
• Static Characteristics:
describe the performance for dc or very low frequency input.
• Dynamic Characteristics:
describe the performance for ac and high frequency input.
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1.9 Generalized Static Characteristics
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Parameters used to evaluate medical instrument:
• Accuracy:
The difference between the true value and the measured value divided by the true value
• Precision:
The number of distinguishable alternatives from which a
given results is selected {2.434v or 2.43v}
• Resolution:
The smallest increment quantity that can be measured
with certainty
• Reproducibility:
The ability to give the same output for equal inputs applied over some period of time.
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1.9 Generalized Static Characteristics
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Parameters used to evaluate medical instrument:
• Statistical Control:
Accuracy is meaningful if all environmental factors are known Ensures:
Systematic errors or bias are tolerable or can be removed by calibration.
Systematic error / bias can be removed by calibration / correction factors , but random variation more difficult
• Statistical Sensitivity:
Static calibration = hold all inputs constant except one incrementally increase
that input
The ratio of the incremental output quantity to the incremental input quantity, Gd.
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Finding static sensitivity G _{d} using line equation with the minimal sum of the squared difference between data points and the line
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1.9 Generalized Static Characteristics
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Zero Drift: all output values increase or decrease by
the same amount due to manufacturing misalignment,
variation in ambient temperature, vibration,….
Sensitivity Drift: Output change in
proportion to the magnitude of the input. Change in the slope of the calibration curve.
Figure 1.3 (b) Static sensitivity: zero drift and
sensitivity drift. Dotted lines indicate that
zero drift and sensitivity drift can be negative.
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Linearity
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Independent nonlinearity
(y _{1} + y _{2} )
and
Linear 
y 
2 
system 
and
Linear
system
Ky _{1}
 A% deviation of the reading
 B% deviation of the full scale
^{x} _{2}
Kx _{1}
A% of reading
x _{d} (Input)
Leastsquares
straight line
(a)
B% of full scale
Figure 1.4 (a) Basic definition of linearity for a system or element. The same linear system or element
is shown four times for different
inputs. (b) A graphical illustration of independent nonlinearity equals A% of the reading, or B% of full scale, whichever is greater (whichever permits the larger error).
Input Ranges ( I ):
Point at which A% of reading = B% of full scale
(b)
Minimum resolvable input < I < normal linear operating range
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Example
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A linear system described by the following equation y=2x+3. Find the overall tolerance band for the system if the input range is 0 to 10 and its independent
nonlinearity is 0.5% deviation of the full scale and 1.5% deviation of the reading.
0.5% FSD = .05 1.5% Rdng = .15
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Input Impedance
Disturb the quantity being measured.
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• X _{d}_{1} : desired input (voltage, force, pressure)
• X _{d}_{2} : implicit input (current, velocity, flow)
• P = X _{d}_{1} .X _{d}_{2} :Power transferred across the tissuesensor interface
• Generalized input impedance Z _{x}
Z x
X
d1
X d2
effort variable
flow variable
P
X
d1
X
d2
X
2
d1
Z
x
Z
x
X
2
d2
•Goal: Minimize P, when measuring effort variable X _{d}_{1} , by maximizing Z _{x} which in return will minimize the flow variable X _{d}_{2} . •Loading effect is minimized when source impedance Z _{s} is much smaller then the Z _{x}
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1.10 Generalized Dynamic Characteristics
Most medical instrument process signals that are functions of time. The input x(t) is related to the output y(t) by
a
n
d
n
y
dt
n
a
1
dy
dt
a
0
( )
y t
b
m
d
m
x
dt
m
b
1
dx
dt
b x t
0
( )
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a _{i} and b _{i} depend on the physical and electrical parameters of the system.
a
n
D
n
a D
1
a
0
y t
( )
b
m
D
m
b D
1
b
0
x t
( )
Transfer Functions
The output can be predicted for any input (transient, periodic, or random)
y
(
D
)
x
(
D
)
b m 
D 
m 
b D 1 

b 
0 

a 
n 
D 
n 
a D 1 

a 
0 
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Frequency Transfer Function Can be found by replacing D by j
y 
( 
D 
) 
b m 
D 
m 
b D 1 
b 
0 



x 
( 
D 
) 
a n 
D 
n 
a D 1 
a 
0 

j ) 
Y ( jω ) 

b 
m 
( 
jω 
) 
m b 
1 
( jω 
) 

b 
0 



X ( jω ) 
a 
n 
( 
jω 
) 
n a 1 
( jω 
) 

a 
0 
H (
Example:
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If 
x(t) = A _{x} sin ( t) 
then 
y(t) = H() A _{x} sin ( t + /_H()) 
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ZeroOrder Instrument
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a _{0} y(t) = b _{0} x(t)
y 
( 
D 
) 
Y 
( 
jω ) 




x 
( 
D 
) 
X 
( 
j 
) 
b
0
a
0
K
K: static sensitivity
Figure 1.5 (a) A linear potentiometer, an example of a zeroorder system. (b)
Linear static characteristic
for this system. (c) Step
response is proportional to input. (d) Sinusoidal frequency response is constant with zero phase shift.
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FirstOrder Instrument
a
1
dy t
( )
dt
a
0
( )
y t
b x t
0
( )
τD1y(t) _{} _{K}_{x}_{(}_{t}_{)}

a 
1 

a 
0 

y 
( 
D 
) 
K 



x 
( 
D 
) 
1 τD 
K
b
0
a
0
y
t
K
1

e 
t /
Where is the time constant
arctan
 ω
τ/1
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FirstOrder Instrument
y 
( 
D 
) 
K 



x 
( 
D 
) 
1 τD 
y
t
K
1

e 
t /
Example 1.1:
Lowpass filter
(a)
1
x (t)
t
(c)
(d)
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SecondOrder Instrument Many medical instrument are 2 ^{n}^{d} order or higher
a
2
d
2
y t
dt
2
a
1
dy t
dt
a yt
0
b xt
0
D
2
ω
2
n
2
ζD
ω
n
1
yt
Kxt
K
b
0
static sensitivity, output units defined by input units
ω n
undamped natural frequency, rad/s
Operational Transfer Function
Frequency Transfer Function
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arctan
2 ζ
ω ω
/
n

/
ω ω
n
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2 ^{n}^{d} order mechanical forcemeasuring Instrument
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B = viscosity constant K _{s} = spring constant
x t

B
dy t
dt
Natural freq.
Damping ratio

K
s
y t
M
d
2
y t
dt
2
Figure 1.7 (a) Forcemeasuring spring scale, an example of a secondorder instrument. (b) Static sensitivity. (c) Step response for overdamped case = 2, critically damped case = 1, underdamped
case = 0.5. (d) Sinusoidal steadystate frequency
response, = 2, = 1, = 0.5.
(c)
Input x(t)
(b)
Resonance
^{}
0.5
Log
scale
K
n
Log scale
(d)
0
90°
180°
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Overdamped
ζ 1:
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Critically damped
ζ 1:
yt
1

ω tKe
n
 ω t
n
Underdamped
ζ 1:
K
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Example 1.2: for underdamped secondorder instruments, find the damping ratio from the step response
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y t 
 ζω t
e
n
2
1  ζ
K sin 
K 


3 π / 2 
t
n
2
ω
1 
ζ
n
and K 
7 π / 2 
t
n 1
2
ω
1 
ζ
n
3 π / 2  

y 
n 
2
1  ζ
ζω exp n 
ω 
n
1

ζ
2 


y n 1 
K 
 ζω 

7 π / 2  



2
1  ζ
2 πζ exp ln 
n y n 
ω 
n
2
1

ζ

2 πζ 
ζ 

49 exp 
2
1  ζ
y n 1 Logarithmic decrement 
2
1  ζ 

2 4 π 
2 
Time Delay System
Output is exactly as input, only delayed
0 °
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Design Criteria
Figure 1.8 Design process for
medical instruments
Choice and design of instruments
are affected by signal factors,
and also by environmental, medical, and economic factors.
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Commercial Medical Instrumentation Development Process
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•Ideas: come from people working in the health care •Detailed evaluation and signed disclosure
•Feasibility analysis and product description
•Medical need •Technical feasibility
•Brief business plan (financial, sales, patents, standards, competition) •Product Specification (interface, size, weight, color)
“What” is required but nothing about “how”
•Design and development (software and hardware)
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Commercial Medical Instrumentation Development Process
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•Prototype development •Testing on animals or human subjects
•Final design review (test results for, specifications, subject feedback, cost)
•Production (packaging, manual and documents)
•Technical support
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Regulation of Medical Devices
Medical devices is “any item promoted for a medical
purpose that does not rely on chemical action to achieve its
intended effect”
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2 Ways for Medical Devices Classification
First Method: (based on potential hazards)
Class I: general controls Class II: performance standards
Class III: premarketing approval
Second Method: (see Table 1.2 in textbook)
preamendment, postamendment, substantially equivalent,
implant, custom, investigational, transitional
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Regulation of Medical Devices
Second Way of classifications: ( Table 1.2 )
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Preamendment: Devices on the market before 5/28/1976
Postamendment: Devices on the market after 5/28/1976 Substantially equivalent: Equivalent to preamendment devices
Implant: devices inserted in human body and intended to remain there for >30 days.
Custom: Devices not available to other licensed and not in finished form Investigational: Unapproved devices undergoing clinical investigation Transitional: devices that were regulated as drugs and now defined as
medical devices
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