The document discusses the classification of medical equipment according to risk levels set by the FDA and protection against electric shock. Medical equipment is classified into three classes based on risk, with class I being low-risk non-electric devices and class III being high-risk life-sustaining devices. Electrical medical equipment is further classified based on its method of protection against electric shock as class I, II, or III. Class I uses a protective earth, class II uses double insulation, and class III operates at safety extra low voltage not exceeding 25V AC or 60V DC.

1. CLASSIFICATION OF
MEDICAL EQUIPMENTS
DR.MAHESWARI JAIKUMAR
maheswarijaikumar2103@gmail.com

2. MEDICAL EQUIPMENT
• Medical equipment (also known
as armamentarium) is designed
to aid in the diagnosis,
monitoring or treatment
of medical conditions.

3. • The Heath Care team members use
medical equipments for diagnosis,
treatment and monitor medical
conditions.
• The medical equipments are purchased
and maintained by experts called Bio
Medical Engineers

4. BIO MEDICAL ENGINEERS
• The biomedical engineers, perform such
tasks as the evaluation, inspection,
repair, maintenance, and installation of
diverse instrumentation, including
electrosurgical equipment; ultrasound
devices; chemical analyzers;
defibrillators; centrifuges; x-ray
instrumentation in a health care setting

5. BASIC MEDICAL EQUIPMENTS
• There are several types of basic durable medical
equipment in a hospital such as the following:
• Manual wheelchairs or electric wheelchairs.
• Hospital beds.
• Walkers, crutches, canes (or any similar type of
mobility assistive equipment)
• Traction equipment.
• Pressure mattresses.
• Insulin pumps.
• Breast pumps.
• Nebulizers.

6. CLASSIFICATION OF MEDICAL
EQUIPMENT OR MEDICAL DEVICES
• The Federal Drug Administration
(FDA) classifies medical devices as :
Class I, Class II, and Class III. The
classification for a device depends
upon the level of risk that is
associated with the device and the
typer of service performed

7. CLASSES OF EQUIPMENT
• There are 3 classes of medical devices:
• Class I devices are low-risk devices.
Examples include bandages, handheld
surgical instruments, and nonelectric
wheelchairs.
• Class II devices are intermediate-risk
devices. .
• Class III devices are high-risk devices
that are very important to health or
sustaining life.

8. CLASSIFICATION
• All electrical equipment is
categorised into classes
according to the method of
protection against electric shock
that is used.

9. CRITERIA FOR CLASSIFICATION
CLASSIFICATION DEPENDS UPON :
• Method of protection against
electric shock.
• Different areas of application and
therefore different electrical safety
requirements.

10. • For mains powered electrical
equipment there are usually two
levels of protection used, called
"basic" and "supplementary"
protection. The supplementary
protection is intended to come
into play in the event of failure
of the basic protection.

11. CLASS I EQUIPMENT
• 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.

12. SYMBOL SEEN ON EARTHED
EQUIPMENT

13. • 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.

14. • 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.

15. • It is important to realise that not all
equipment having an earth
connection is necessarily class I.
• The earth conductor may be for
functional purposes only such as
screening

16. • In this case the size of the
conductor may not be large enough
to safely carry a fault current that
would flow in the event of a mains
short to earth for the length of time
required for the fuse to disconnect
the supply.

17. • Class I medical electrical equipment
should have fuses at the equipment
end of the mains supply lead in both
the live and neutral conductors, so
that the supplementary protection
is operative when the equipment is
connected to an incorrectly wired
socket outlet.

18. • There is no agreed symbol in use
to indicate that equipment is
class I and it is not mandatory to
state on the equipment itself
that it is class I. Where any
doubt exists, reference should be
made to equipment manuals.

19. • The symbols below may be seen
on medical electrical equipment
adjacent to terminals.
SYMBOL SEEN ON EARTHED
EQUIPMENT

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

21. • 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.

22. • In practice, the basic insulation
may be afforded by physical
separation of live conductors
from the equipment enclosure,
so that the basic insulation
material is air.
• The enclosure material then
forms the supplementary
insulation.

23. • Reinforced insulation is defined
in standards as being a single
layer of insulation offering the
same degree of protection
against electric shock as double
insulation.

24. • Class II medical electrical
equipment should be fused at
the equipment end of the supply
lead in either mains conductor or
in both conductors if the
equipment has a functional
earth.

25. • The symbol for class II
equipment is two concentric
squares illustrating double
insulation as shown below.
• Symbol for class II equipment

26. CLASS III EQUPMENT
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.

27. • In practice such equipment is either
battery operated or supplied by a
SELV transformer.
• 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.

28. Equipment powered from a SELV
transformer should be tested in
conjunction with the
transformer as class I or class II
equipment as appropriate.

29. • The current IEC standards
relating to safety of medical
electrical equipment do not
recognise Class III equipment
since limitation of voltage is not
deemed sufficient to ensure
safety of the patient.

30. • All medical electrical equipment
that is capable of mains
connection must be classified as
class I or class II.
• Medical electrical equipment
having no mains connection is
simply referred to as "internally
powered".

31. MEDICAL ELECTRICAL EQUIPMENT TYPES
TYPE SYMBOL DEFINITION
B
Equipment providing a particular degree
of protection against electric shock,
particularly regarding allowable leakage
currents and reliability of the protective
earth connection (if present).
BF
As type B but with isolated or floating (F -
type) applied part or parts.
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.

32. THANK YOU