University of Gondar

Institute of Technology
Biomedical Engineering Department
Health care technology management
Part 4
By: Muhammed.E.
Introduction to equipment calibration,
inspection and testing
 What you
cannot measure
Why Test & you cannot
Calibration? control
Con..
• Testing and calibration of bio-medical equipment to ensure quality
control in equipment is becoming increasingly significant today when
accuracy in diagnosis and effectiveness in treatment cannot be
compromised at all.
 Calibration

• Calibration: process of comparing an unknown against a reference

standard within defined limits, accuracies and Uncertainties.

• ANSI, AAMI, IEC 60601, UL, NFPA, ISO 13485, IEEE

• The FDA’s Quality System Regulation.

• Manufacture
Periodically calibrating equipment ensures
• Accuracy
• Efficiency
• Safety
• Standards
• Reliability
• Longer life of equipment
• Uniform Performance of multiple units
which ultimately enables one to achieve the highest degree of quality control.
Accuracy & Precision
• The quantity we want to measure has a “true” value.
• We use a measuring instrument and obtain a reading.
• If the measured value is close to the true value, the measuring system
has high accuracy.
• If we measure a quantity multiple times with the same system under
the same conditions, we will get different values.
• If the spread of the values is small, the measuring system has high
precision.
Benefits of calibrating medical devices
• Superior quality of healthcare
• Enhance patients confidence
• Mandate for accreditation process (like NABH)
• Provides patients safety against electrical hazard
• Reduces risk due to equipment malfunction and increases
patients safety
After Equipment Installation
Inventory Record

Operating
Calibration Verification Procedures

Maintenance Program

Train ALL Operators

Requirements of Test & Calibration service
• Written Program
• Routine calibration or verification at suitable intervals
• Control of inspection, measuring and test equipment.
• Calibration procedures including specific directions and limits for
accuracy and precision
• Deviation or discrepancies should be investigated
• Traceable Calibration Standards
• Calibration records
• Visible Calibration status
 Equipment Calibration
• Perform initial calibration
• Use calibrators or standards
• Follow manufacturer’s
instructions
• Determine frequency of routine
calibrations
Performance Evaluation
Test known samples,
analyze data

Establish stability
for temperature-
controlled equipment

Validate
performance with
parallel samples
Function Checks
Monitor instrument parameters:
• Periodically, daily, weekly, monthly
• After major instrument repair

Examples:
• Incubator temperatures
• Wavelength calibration
• Autoclave temperature chart
Inspection
It is the process of measuring, examining, and testing to gauge one or more
characteristics of a service and the comparison of these with standards to
determine conformity.
Hospitals require their medical devices performing to the expected standards
of
• Accuracy
• Reliability
• Free of hysteresis and linear
• Safe & Effective
• Economical & Available
• Met regulations, accreditation requirements and standards.
Con..
• Inspection is a special calibration with
• Additional functional tests defined by the Rules on Metrological
Requirements.
• Only for those instruments
• Type test has already been performed
• Type approval certificate has been issued
• With the Rules on Metrological Requirements
When to test
• On newly acquired equipment prior to being accepted for use
• During routine planned preventative maintenance.
• After repairs have been carried out on equipment.
Con..

• We can divide Medical Equipment Calibration devices in to three

types:
Electrical Safety Analyzers
Performance Analyzers
Simulators & Controllers
Electrical Safety Analyzers
Electrical Safety Analyzer performs all primary electrical safety tests,
including
• Mains (line) voltage
• Protective earth(ground wire) resistance,
• MAP (insulation) resistance,
• Device current, and
• Applied parts (patient leakage) tests.

601 Pro Series XL International Safety Analyzer

Performance Analyzers
Infusion Device Analyzer

• The infusion device tester measures instantaneous flow, average flow,

occlusion pressure, and analyzes patient-control analgesia (PCA)
units.

• Infusion device tester records infusion pump test results internally and
provides easy-to-read test-result graphs live right on the analyzer’s
screen.
Con..
Incubator Analyzer

• Incubator Analyzer specifies temperature, humidity, sound and airflow

characteristics of incubators.

Pressure Meters

• Universal Pressure Meter is designed to measure the positive and negative

pressures of medical devices in either liquid or gaseous form to assist in
repair and quality control.
Con..
Oxygen Analyzers
• Analyzer that measures the oxygen concentration in a flow of gas from a medical gas source or through a
medical gas flow device such as a ventilator or anesthesia system
Simulators & Controllers
• Multiparameter Patient Simulators

• Non-Invasive Blood Pressure Simulators

• Sp02 Simulators

• Fetal Simulators
Same examples
Con..
Assignment 3
• Select different medical device testing material and
describe what it measure, how it measure and the
drawback of the testing materials. (5pts)