Study Oriented Project on Various Biomedical Instruments and their Design

Under the guidance of Dr. Judith Braganca

A Presentation Harshit Somani 2009B1A8633G

The Non-Technical Aspects

What is a Medical Device?
Cope with human disease. Care for human injuries. Meet human anatomical needs. Maintain human physiological functions. Support or sustain human life. Examine specimens taken from human bodies.

Manufactured products that achieve results by pharmacological, immunological, or metabolic means are not medical devices.

The ISO Standards

ISO 13485:2003 - facilitate harmonized medical device regulatory requirements for quality management systems All requirements of ISO 13485:2003 are specific to organizations providing medical devices, regardless of the type or size of the organization.

Various Other Standards

Packaging Standards Cleanliness Standards

Classification of Medical Devices

Class I devices are defined as non-life sustaining. These products are the least complicated and their failure poses little risk. Class II devices are more complicated and present more risk than Class I, though are also non-life sustaining. They are also subject to any specific performance standards. Class III devices sustain or support life, so that their failure is life threatening

Regulation in India
The Central Drug Standard Control Organization (CDSCO) Schedule M-III, defined by Health Ministry

Basic Sensors and Principles

A transducer is a device that converts energy from one form to another.
An actuator converts an electric signal to a physical output.

Displacement Measures
Potentiometers
Used to measure rotational and translational displacements

Strain Gauges

Bridge Circuits

 Inductive Sensors
L = n2Gu Most famous is the LVDT

Capacitive Sensors
Capacitance Sensor

Piezoelectric Sensors Thermocouples LEDs

Amplifiers and Signal Processing

Operational Amplifiers
Ideal Inverting Non-Inverting

Comparators Rectifiers Filters

The Origin of Biopotentials

Action Potential Volume Conductor Fields EMG ECG ERG

Future Trends
Miniaturization of medical devices will allow for more targeted delivery of therapies Replacement organs and tissue engineering advances will provide radical new options for addressing the most serious disease conditions Molecular and gene-based diagnostics will detect diseases earlier in its progression, improving patient outcomes and lowering treatment costs

Thank You