Safety Testing of Medical

Electrical Equipment
1 Hazards of Medical Electrical Equipment
1.1 Mechanical Hazards
1.2 Risk of fire or explos
1.3 Absence of Functionion
1.4 Excessive or insufficient output
1.5 Infection
1.6 Misuse
1.7 Risk of exposure to spurious electric
currents
2 Physiological effects of electricity
2.1 Electrolysis
2.2 Burns
2.3 Muscle cramps
2.4 Respiratory arrest
2.5- cardiac arrest
2.6- ventricular fibrillation
2.7- effect of frecqency on neuro-
muscular stimulation
3 Classes and types of medical electrical equipment

 4.1- class I equipment

Figure 6. Symbols seen on earthed equipment

 3.2 class IIequipment

Figure 7. Symbol for class II equipment.

3.3 Class III equipment

SELV (Safety Extra Low Voltage )

SELV :is defined in turn in the relevant

standard as a voltage not exceeding 25V
ac or 60V dc.
4.4 Equipment types

Type Symbol Definition

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

Equipment providing a
higher degree of protection
CF against electric shock than
type BF, particularly with
regard to allowable leakage
currents, and having
floating applied parts.
•3 Leakage currents

3.1 Causes of leakage currents

a- the voltage on the conductor.

b- the capacitive reactance between the
conductor and earth.
c- the resistance between the conductor and
earth
3.2 Earth leakage current
types BF & CF
ALL CLASS I 500micr A
4.3 Enclosure leakage current
for class I,II,
TYPES B&BF 100micrA,
TYPE CF 10 micr A
4.4 Patient leakage current
type B &BF 100micrA
type CF10micrA per part of apply part

Patient leakage current path from equipment . Patient leakage current path to
equipment.
4.5 Patient auxiliary current
classI&II
for type B&BF&CF 10 micrA
6.10 Leakage current summary

Leakagec Type B Type BF Type CF

urrent

Earth 0.5 1 0.5 1 0.5 1

Earth for
fixed 5 10 5 10 5 10
equipmen
t
Enclosure 0.1 0.5 0.1 0.5 0.1 0.5

Patient 0.1 0.5 0.1 0.5 0.01 0.05

Mains on
applied - - - 5 - 0.05
part
Patient 0.1 0.5 0.1 0.5 0.01 0.05
auxiliary
•5 Testing regimes and relevant documentation

5.1 Type tests and routine tests

5.2 HTM 8
5.3 BS 5724 or IEC 60601
5.4 Hospital Equipment Information 95
5.5 DB9801 Supplement 1
5.6 Medical Devices Directive
5.7 ESCHLE
5.8 IEC 61010
5.9 Hospital Equipment Information 140
5.10 When to test
Medical electrical equipment should be inspected and
tested on the following occasions.

a- On newly acquired equipment prior to being

accepted for use
b- During routine planned preventative
maintenance.
c- After repairs have been carried out on
equipment.
5.11 Recording test results

5.12 Equipment Management Software

Packages
SAFETY ANALYSER
6 Electrical Safety Tests
6.1 Normal condition and single fault conditions
*Normal operation means provided for protection against
safety hazards are intact
*Single fault is a condition in which signal means of
protection
•Against safety hazard is defective or external abnormal
condition is present such as:
•1- interruption of one protective earth conductor

•2-the intrupt of on supply conductor of equipment

•3 -the short circuiting of either constituent part of

• double insulation
6.2 Protective Earth Continuity

Applicable to Class I, all types

Limit: 0.2

DB9801 Yes, at 1A or
recommended?: less.

HEI 95 Yes, at 1A or
recommended?: less.

Notes: Ensure probe is

on a protectively
earthed point
6.3 Insulation Tests
Applicable to Class I, all types

Limits: Not less than

50MΩ

DB9801 Yes
recommended?:

HEI 95 Yes
recommended?:

Equipment
containing
mineral insulated
heaters may give
Notes: values down to
1MΩ. Check
equipment is
switched on.
 Applicable to Class II, all
types having
applied parts

Limits: not less than

50MΩ.

DB9801 not less than

recommended?: 50MΩ.

HEI 95 Yes
recommended?:

Notes: Move probe to

find worst case
6.4 Leakage current measuring device
6.5 Earth Leakage Current
Class I
Applicable to equipment, all
types
0.5mA in NC,
1mA in SFC or
Limits: 5mA and 10mA
respectively for
permanently
installed
equipment.
DB9801 Yes, in normal
recommended?: condition only.

HEI 95 Yes, in normal

recommended?: condition only.
Measure with
mains normal
Notes: and reversed.
Ensure
equipment is
switched on.
 6.6 Enclosure leakage current
Applic Class I and class II
able to equipment, all types.

Limits: 0.1mA in NC, 0.5mA in SFC

DB980
1
recom Yes, NC only
mende
d?:
HEI 95
recom Yes, class I SFC earth
mende open circuit, class II NC.
d?:

Ensure equipment
switched on. Normal and
Notes:
reverse mains. Move
probe to find worst case.
6.7 Patient leakage current
All classes, type B
& BF equipment
Applicable to having applied
parts.

Limits: 0.1mA in NC,

0.5mA in SFC.
DB9801 No
recommended?:
Yes, class I SFC
HEI 95 earth open circuit,
recommended?: class II normal
condition.

Equipment on but
Notes: outputs inactive.
Normal and
reverse mains.
Measurement of patient leakage current for each
applied part in turn
Class I and class II, type CF (B &
Applicable to BF for DB9801 only) equipment
having applied parts.
Limits: 0.01mA in NC, 0.05mA in SFC.

DB9801 recommended?: Yes, all types, normal condition

only.
HEI 95 recommended?: Yes, type CF only, class I SFC earth
open circuit, class II normal
condition.
Equipment on but outputs inactive.
Notes: Normal and reverse mains. Limits
are per electrode.
6.8 Patient auxiliary current
All classes and types
Applicable to of equipment having
applied parts.

Type B & BF -
0.1mA in NC, 0.5mA
Limits: in SFC.
Type CF - 0.01mA in
NC, 0.05mA in SFC.
DB9801 No.
recommended?:
HEI 95 No.
recommended?:
Ensure outputs are
Notes: inactive. Normal
and reverse mains
6.9 Mains on applied parts
Applicable to Class I & class II,
types BF & CF
having applied
parts.
Limit: Type BF - 5mA;
type CF - 0.05mA
per electrode.
DB9801 No.
recommended?:
HEI 95 No
recommended?:
Notes: Ensure outputs are
inactive. Normal
and reverse mains.
Caution required,
especially on
physiological
measurement
equipment.