MEDICAL EQUIPMENT

CLASSIFICATION
CLASS AND TYPES
PRESENTED BY
SANGEETHA SASIDHARAN

CLASSIFICATION OF MEDICAL
EQUIPMENT
A medical device is designed to improve patients health in
diagnosis, therapy or surgery.
Medical devices are classified into three classes based on the US
classification system, which defines the amount of risk involved
with the medical device and proper procedures that must be
followed when using and manufacturing the device.

The medial devices are categorized by class for the purpose of

informing patients, doctors and manufacturers the amount of risk
involved and the intention for the medical device.

DIAGNOSTIC EQUIPMENT

THERAPUTIC EQUIPMENT

CLASS I MEDICAL DEVICES

Class I equipment has a protective earth.
The basic means of protection is the insulation between live parts
and exposed conductive parts such as the metal enclosure.
In the event of a fault that would otherwise cause an exposed
conductive part to become live, the supplementary protection (i.e.
the protective earth) comes into effect.
A large fault current flows from the mains part to earth via the
protective earth conductor, which causes a protective device
(usually a fuse) in the mains circuit to disconnect the equipment
from the supply.

CLASS II MEDICAL DEVICES

The method of protection against electric shock in the case of class II
equipment is either double insulation or reinforced insulation.

In double insulated equipment the basic protection is afforded by

the first layer of insulation.

If the basic protection fails then supplementary protection is

provided by a second layer of insulation preventing contact with
live parts.

CLASS III MEDICAL DEVICES

Class III equipment is defined in some equipment
standards as that in which protection against electric
shock relies on the fact that no voltages higher than
safety extra low voltage (SELV) are present.
SELV is defined in turn in the relevant standard as a
voltage not exceeding 25V ac or 60V dc.
If battery operated equipment is capable of being
operated when connected to the mains (for example,
for battery charging) then it must be safety tested as
either class I or class II equipment.

EQUIPMENT TYPES

The degree of protection for medical electrical equipment is defined

by the type designation.

The reason for the existence of type designations is that different

pieces of medical electrical equipment have different areas of
application and therefore different electrical safety requirements.

TYPES OF MEDICAL EQUIPMENT

TYPE B EQUIPMENT

Equipment providing a particular degree of protection against

electric shock, particularly regarding allowable leakage currents and
reliability of the protective earth connection (if present).

Type B is the least stringent classification, and is used for applied

parts that are generally not conductive and can be immediately
released from the patient.

TYPES OF MEDICAL EQUIPMENT

TYPE BF EQUIPMENT
Floating isolated applied part.it is only intended for connection to
patients skin but has floating input circuits.no connection between
patients and earth.

BF

As type B but with isolated or floating (F - type) applied part or

parts.
Type BF is less stringent than CF, and is generally for devices that have
conductive contact with the patient, or having medium or long term
contact with the patient.

TYPES OF MEDICAL EQUIPMENT

TYPE CF EQUIPMENT

CF

Equipment providing a higher degree of protection against

electric shock than type BF, particularly with regard to allowable
leakage currents, and having floating applied parts.
Type CF is the most stringent classification, being required for
those applications where theapplied partis in direct conductive
contact with the heart or other applications as considered
necessary.

EQUIPMENT SYMBOLS

CODES AND STANDARDS

A code is a document that contains mandatory requirements.it uses

the word shall.is generlly adopted into law by autority that has
jurisdiction.

A standard is a document that contains mandatory requirements,but

compliance tends to be voluntary

CODES AND STANDARDS

FDA -Food and drug administration

IEC
-International electrochemical committee
NFPA -National fire protection association
ANSI -American national standards institute
AAMI -Advancement of medical instrumentation
BSI
-British standards institute
ISO -International organization for standardization
ECRI -Emergency care research institute
HEMA -Health industry manufacturers assoiciation
NEMA -National electrical manufacturers association
NEC - National electrical code

IMPORTANT STANDARDS AND CODES

IEC :International electrotechnical committee

NFPA99 :Standards for health care facilities

ANSI/AAMI ES1-1993 :Safe current limits for electromedical

BS 5724 : Electrical safety of medical equipment

ELECTRICAL SAFETY
The increased use and complexity of medical systems result in
10,000 device related injuries in the USA each year.
Hazardous sources include electricity, fire, water, chemicals,
drugs, germs, x-rays, EM fields, etc.
There are now performance standards that were written for
medical devices.
Our main objectives are to understand the possible electrical
hazards and fault scenarios and learn how to improve deigns of
medical instruments

EQUIPMENT DESIGN TO ENSURE

PATIENT SAFETY
Reliable grounding of equipment
Reduction of leakage current
Operation at low voltage
Driven- right-leg circuit
Use of current limiters
Electric isolation of patient circuit
Equipotential grounding
Ground faults interrupters
Proper wiring distribution and gr
Line isolation system and monitors

THANKYOU