IEC standards

 IEC 60601-1 – Medical electrical equipment – Part 1: General requirements for basic
safety and essential performance
 IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic
safety and essential performance - Collateral Standard: Electromagnetic disturbances -
Requirements and tests
 IEC 60601-1-6 Medical electrical equipment - Part 1-6: General requirements for basic
safety and essential performance - Collateral standard: Usability
 IEC 60601-2-2 Medical electrical equipment - Part 2-2: Particular requirements for the
basic safety and essential performance of high frequency surgical equipment and high
frequency surgical accessories
 IEC 60601-2-24 Medical electrical equipment - Part 2-24: Particular requirements for the
basic safety and essential performance of infusion pumps and controllers
 IEC 60601-2-25 Medical electrical equipment - Part 2-25: Particular requirements for the
basic safety and essential performance of electrocardiographs
 IEC 60601-2-27 Medical electrical equipment - Part 2-25: Particular requirements for the
basic safety and essential performance of electrocardiographs monitoring equipment
 IEC 80601-2-30 Medical electrical equipment – Part 2-30: Particular requirements for the
basic safety and essential performance of automated non-invasive sphygmomanometers
 IEC 62304 Medical device software – Software life cycle processes
 IEC 62366-1 Medical electrical equipment – Part 1: Application of usability engineering to
medical devices

Standards Definition Description
1-1 General requirements for
basic safety and essential
performance

1-2 Electromagnetic
compatibility

1-6 Usability This International Standard specifies a PROCESS for a

MANUFACTURER to analyse, specify, develop and
evaluate the USABILITY, as it relates to BASIC SAFETY and
ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL
EQUIPMENT, hereafter referred to as ME EQUIPMENT.

This USABILITY ENGINEERING PROCESS assesses and

mitigates RISKS caused by USABILITY problems
associated with CORRECT USE and USE ERRORS, i.e.,
NORMAL USE. It can be used to identify but does not
assess or mitigate RISKS associated with ABNORMAL
USE.

If the USABILITY ENGINEERING PROCESS detailed in this

collateral standard has been complied with, then the
USABILITY of ME EQUIPMENT as it relates to BASIC
SAFETY and ESSENTIAL PERFORMANCE is presumed to
be acceptable, unless there is OBJECTIVE EVIDENCE to
the contrary.

NOTE: Such OBJECTIVE EVIDENCE can subsequently

originate from POST-PRODUCTION surveillance.

Link: https://global.ihs.com/doc_detail.cfm?
document_name=IEC
%2060601%2D1%2D6&item_s_key=00440980
1-8 Alarms
1-9 Environmentally
conscious design
1-11 Home health care
environment
2-2 High frequency surgical
equipment and high
frequency surgical
accessories

2-24 Infusion pumps and

controller
2-25 Electrocardiographs
 2-27 Electrocardiographs
monitoring equipment
2-47 Ambulatory
electrocardiograph
systems

80601
2-30 Automated 201.3.207
noninvasive NEONATAL MODE
sphygmomanometers Age range
Neonate-birth to 1 month
Infant-1 month to 2yrs (Upto 3yrs also)
The NEONATAL MODE is used to limit the maximum
pressure to 150 mmHg and frequently has a different
algorithm from other modes intended for older
PATIENTS.
201.3.209
Patient simulator

201.12
Accuracy of controls and instruments and protection
against hazardous outputs

201.12.101 Measuring and display ranges

The measuring and display ranges of the CUFF pressure
shall be equal to the RATED range for CUFF pressure.
Values of BLOOD PRESSURE outside the RATED range for
BLOOD PRESSURE shall not be displayed, and the
AUTOMATED SPHYGMOMANOMETER shall be equipped
with an ALARM SYSTEM that includes a TECHNICAL
ALARM CONDITION that indicates when the determined
BLOOD PRESSURE is outside the RATED range.
Compliance is checked by testing.

201.12.1.102 Limits of the error of the manometer from

environmental conditions
Over the temperature range of 10 °C to 40 °C and the
relative humidity range of 15 % to 85 % (non-
condensing), the maximum error for the measurement
of the CUFF pressure at any point of the NOMINAL
measurement range shall be less than or equal to ±3
mmHg (±0,4 kPa) or 2 % of the reading, whichever is
greater.
Compliance is checked by testing.

201.12.1.103 * NOMINAL BLOOD PRESSURE indication

range
The AUTOMATED SPHYGMOMANOMETER shall be
capable of indicating DIASTOLIC BLOOD PRESSURE over
at least the range of 20 mmHg (2,7 kPa) to 60 mmHg (8,0
kPa) in NEONATAL MODE and 40 mmHg (5,3 kPa) to 130
mmHg (17,3 kPa) otherwise. The AUTOMATED
SPHYGMOMANOMETER shall be capable of indicating
SYSTOLIC BLOOD PRESSURE over at least the range of 40
mmHg (5,3 kPa) to 110 mmHg (14,7 kPa) in NEONATAL
MODE and 60 mmHg (8,0 kPa) to 230 mmHg (30,7 kPa)
otherwise.
Compliance is checked with the following test:

a) Connect the AUTOMATED SPHYGMOMANOMETER to

a PATIENT SIMULATOR.

b) Adjust the PATIENT SIMULATOR to generate signals in

such a way that the AUTOMATED
SPHYGMOMANOMETER displays DIASTOLIC BLOOD
PRESSURE values of 20 mmHg (2,7 kPa) or less and
SYSTOLIC BLOOD PRESSURE values of 110 mmHg (14,7
kPa) or more in NEONATAL MODE and DIASTOLIC BLOOD
PRESSURE values of 40 mmHg ( 5,3 kPa) or less and
SYSTOLIC BLOOD PRESSURE values of 230 mmHg (30,7
kPa) or more otherwise.

201.12.1.104 Maximum pressure in NORMAL

CONDITION
The maximum pressure obtainable in NORMAL
CONDITION shall not exceed 150 mmHg (20 kPa) for an
AUTOMATED SPHYGMOMANOMETER in NEONATAL
MODE and not exceed 300 mmHg (40 kPa) otherwise. An
AUTOMATED SPHYGMOMANOMETER may have one, or
more than one, mode.
Compliance is checked by functional testing in NORMAL
CONDITION.

201.12.1.105 * Maximum pressure in SINGLE FAULT

CONDITION
In any automatic cycling mode of operation, a
PROTECTION DEVICE shall be provided, functioning
independently of the normal PNEUMATIC SYSTEM
control, which in any SINGLE FAULT CONDITION, shall:

a) prevent the pressure in the PNEUMATIC SYSTEM from

exceeding the maximum RATED value specified in
201.12.1.104 by more than 10 % for more than 3 s (see
Figure 201.101); and

b) Activate if the pressure in the PNEUMATIC SYSTEM

exceeds the maximum RATED value specified in
201.12.1.104 for 15 s (see Figure 201.102).

When activated, the PROTECTION DEVICE shall deflate

the PNEUMATIC SYSTEM within 30 s to ≤ 15 mmHg (2,0
kPa) and to ≤ 5 mmHg (0,7 kPa) for an AUTOMATED
SPHYGMOMANOMETER in NEONATAL MODE.
An AUTOMATED SPHYGMOMANOMETER that only
operates in the SELF-MEASUREMENT AUTOMATIC
MODE, where the PATIENT is the OPERATOR or the
OPERATOR is intended to be in continual attendance,
and where the pressure can be released from the CUFF
by the OPERATOR is exempt from this requirement.

EXAMPLE 1 Pressure released by disconnecting the CUFF

from the AUTOMATED SPHYGMOMANOMETER.
EXAMPLE 2 Pressure released by removing the CUFF
from the limb.
Compliance is checked by functional testing in SINGLE
FAULT CONDITION.

201.12.1.106 * Manometer test mode

The AUTOMATED SPHYGMOMANOMETER shall have a

manometer test mode that permits static pressure
measurement over at least the NOMINAL BLOOD
PRESSURE indication range (see 201.12.1.103). This
mode shall not be available in NORMAL USE, but
restricted to SERVICE PERSONNEL.

EXAMPLE 1 A port for connection to a pressure source so

that the pressure can be measured by the AUTOMATED
SPHYGMOMANOMETER in a test mode.

EXAMPLE 2 A port for connection to a reference

manometer that can be pressurized by the AUTOMATED
SPHYGMOMANOMETER in a test mode.

NOTE This mode can be used to verify manometer

pressure accuracy.

The technical description shall include a test method that

can be used to verify the calibration of the AUTOMATED
SPHYGMOMANOMETER.

Compliance is checked by inspection and functional

testing.

201.12.1.107 * Reproducibility of the BLOOD PRESSURE

DETERMINATION
The laboratory reproducibility of the BLOOD PRESSURE
DETERMINATION of the AUTOMATED
SPHYGMOMANOMETER shall be less than or equal to 3,0
mmHg (0,4 kPa).
Compliance is checked with the following test:
Two samples of the AUTOMATED
SPHYGMOMANOMETER of the same MODEL OR TYPE
REFERENCE are needed to perform this test PROCEDURE.

NOTE At the beginning of this compliance test, neither

sample has been subjected to the mechanical stress tests
of the general standard and the collateral standards.
Step h) subjects AUTOMATED SPHYGMOMANOMETER A
to the stress tests, and the laboratory limits of the
change in error of the BLOOD PRESSURE
DETERMINATION are compared before and after these
mechanical stresses.

a) Label one sample of the AUTOMATED

SPHYGMOMANOMETER as A and the other sample as B.

b) Prior to performing the other tests of this document,

adjust the PATIENT SIMULATOR to generate signals in
such a way that the AUTOMATED
SPHYGMOMANOMETER displays approximately a
DIASTOLIC BLOOD PRESSURE value of 40 mmHg (5,3 kPa)
and a SYSTOLIC BLOOD PRESSURE value of 70 mmHg
(9,33 kPa) at a pulse rate of 140 beats/min in NEONATAL
MODE and a DIASTOLIC BLOOD PRESSURE value of 80
mmHg (10,67 kPa) and a SYSTOLIC BLOOD PRESSURE
value of 120 mmHg (16,0 kPa) at a pulse rate of 80
beats/min otherwise. Either sample of the AUTOMATED
SPHYGMOMANOMETER may be used for this step.

c) Perform 20 consecutive DETERMINATIONS with

AUTOMATED SPHYGMOMANOMETER B. Calculate the
means and standard deviations for both the DIASTOLIC
BLOOD PRESSURE and the SYSTOLIC BLOOD PRESSURE.

d) Record these results as the AUTOMATED

SPHYGMOMANOMETER B starting values.

e) Confirm that the standard deviation of the DIASTOLIC

BLOOD PRESSURE and of the SYSTOLIC BLOOD PRESSURE
are ≤ 2,0 mmHg (≤ 0,27 kPa) for the AUTOMATED
SPHYGMOMANOMETER B starting values. If either one
of these criteria is not met, the combination of the
simulator and AUTOMATED SPHYGMOMANOMETER has
insufficient stability to perform this test PROCEDURE.

f) Using the same PATIENT SIMULATOR and settings as in

b), perform 20 consecutive DETERMINATIONS with
AUTOMATED SPHYGMOMANOMETER A. Calculate the
means and standard deviations for both the DIASTOLIC
BLOOD PRESSURE and the SYSTOLIC BLOOD PRESSURE.

g) Record these results as the AUTOMATED

SPHYGMOMANOMETER A starting values.
h) Using AUTOMATED SPHYGMOMANOMETER A,
perform at least the following tests, without the
simulation of SINGLE FAULT CONDITIONS, of this
particular standard: 201.12.1.102, 201.15.3.5.101, and
IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012,
15.3.2, 15.3.3 and 15.3.4 as well as, if applicable, IEC
60601-1-11:2015, 8.3.1, 10.1, and IEC 60601-1-12:2014,
8.1.1 and 10.1.1.

i) Using the same PATIENT SIMULATOR and settings as in

b), perform 20 DETERMINATIONS with AUTOMATED
SPHYGMOMANOMETER A. Calculate the means of the
DIASTOLIC BLOOD PRESSURE and the SYSTOLIC BLOOD
PRESSURE.

j) Record these results as the AUTOMATED

SPHYGMOMANOMETER A ending values.

k) Using the same PATIENT SIMULATOR and settings as in

b), perform 20 DETERMINATIONS with AUTOMATED
SPHYGMOMANOMETER B. Calculate the means of the
DIASTOLIC BLOOD PRESSURE and the SYSTOLIC BLOOD
PRESSURE.

l) Record these results as the AUTOMATED

SPHYGMOMANOMETER B ending values.

m) For AUTOMATED SPHYGMOMANOMETER B ending

values, confirm that the standard deviation of the
DIASTOLIC BLOOD PRESSURE and of the SYSTOLIC
BLOOD PRESSURE are ≤ 2,0 mmHg (≤ 0,27 kPa). If either
one of these criteria is not met, the combination of the
simulator and AUTOMATED SPHYGMOMANOMETER has
insufficient stability to perform this test PROCEDURE.

n) For AUTOMATED SPHYGMOMANOMETER B, confirm

that the absolute value of the difference between the
mean starting values calculated in c) and ending values
calculated in m) are ≤ 2,0 mmHg (≤ 0,27 kPa). If either
one of these criteria is not met, the combination of the
simulator and AUTOMATED SPHYGMOMANOMETER has
insufficient stability to perform this test PROCEDURE.

o) For AUTOMATED SPHYGMOMANOMETER A, confirm

that the absolute value of the difference between the
mean starting values calculated in f) and ending values
calculated in i) are ≤ 5,0 mmHg (≤ 0,67 kPa).
Website link: https://knowhow.distrelec.com/medical-healthcare/medical-and-healthcare-power-
supplies-tdk-lambda/#:~:text=Means%20of%20operator%20protection%20(MOOP,according
%20to%20the%20same%20standard.

 From the standards perspective, a dangerous voltage is a supply above 42.2 VAC or 60
VDC.

Leakage current
Figure 1 illustrates the basic concept of a leakage current (green line) from the live mains supply
through the power supply and the unit’s electronics to the patient or operator. A protective earth
(PE) connection grounds any conductive part of the unit, avoiding any external leakage current, but
it can still occur from other parts of the unit. However, engineers cannot always rely on the reliability
of a PE.

Figure 1 – A simplified diagram of leakage current (source TDK-Lambda)

There are two classifications of products as a result. Also, insulation from hazardous voltages is
defined as functional (necessary), protective (Class I only), basic (single), double (two independent
methods), supplementary (single plus extra) or reinforced (single layer but equivalent to double).

 Class I product: This has at least one level of basic insulation and an additional form of
protection provided by an earth/ground connection.

 Class II product: This has no protective earth connection and must have two layers of
insulation – double or reinforced.

Within IEC 60601, there are limits defined for three distinct types of leakage current:

 Earth leakage current: is current that flows from the unit through the PE of a Class I product.

 Touch leakage current: is current that flows through the patient or operator if they touch
the unit.

 Patient leakage current: is current that flows through the patient via an applied part, i.e.,
not the operator handling the medical equipment. This has several classifications depending
on how an electrical connection is made to the patient.

Applied parts (AP) are defined as:

  B (body): Not normally conductive and can be released from the patient; may be connected
to the earth. Examples include medical lasers and MRI body scanners.

 BF (body floating): Has conductive contact with the patient. Examples include ECG heart rate
monitors and ultrasound scanners.

 CF (cardiac floating): Has or may have direct contact with the patient’s heart. An example is
a dialysis machine.

Figure 2 illustrates a table of the maximum permitted leakage currents defined by IEC 60601-1 3rd
edition in regular operation (RO) and for a single fault condition (SFC).

Figure 2 – A table of the maximum leakage currents defined by IEC 60601-1.

MOP, MOOP and MOPP

The IEC 60601-1 3rd edition standard introduced the means of protection (MOP) for medical and
healthcare equipment and divided it into two categories to differentiate between a patient and the
equipment operator.

Means of operator protection (MOOP): This can either be 1 MOOP or 2 MOOP. 1 x MOOP provides
a ‘basic’ electrical insulation defined by the broad-ranging electrical equipment safety standard IEC
62368-1. 2 x MOOP requires reinforced insulation according to the same standard.

Means of patient protection (MOPP): Similar to MOOP but with increased requirements for
insulation voltage and clearance/creepage defined within IEC 60601-1, 1 x MOPP requires just basic
insulation, and 2 x MOPP requires has reinforced insulation.

F
igure 3 – The insulation and isolation criteria defined by IEC 60601 (source TDK)

The IEC 60601-1 stipulates the requirements for isolation, insulation, creepage and leakage current –
see Figure 3. Creepage is the shortest distance along the surface of insulating material between two
conductive parts. Clearance is the shortest air gap distance between conductive parts. Figure 4
illustrates a simplified view of MOPP in practice, with the electrical isolation provided by a
transformer and wire insulation.

Figure 4 – An example of how MOPP is implemented (source TDK-Lambda)

Dielectric strength:

Test voltage is applied for a duration of 1min

Initially, not more than half the test voltage is applied, and then it is gradually raised
over a
period of 10 s to the full value, which is maintained for 1 min, after which it is gradually
lowered over a period of 10 s to less than half the full value.

a) Either AC or
Alternatively, a d.c. test voltage equal to the peak value of the a.c. test voltage may be
used.

The test voltage, for the WORKING VOLTAGE to which the insulation is subjected is greater
than or equal to the value specified in Table 6.

b) During the test, breakdown constitutes a failure. Insulation breakdown is considered to

have occurred when the current which flows as a result of the application of the test
voltage rapidly increases in an uncontrolled manner, that is, the insulation does not
restrict
the flow of the current. Corona discharge or a single momentary flashover is not
regarded
as insulation breakdown.

-A corona discharge is an electrical discharge brought on by the ionization of a fluid surrounding a

conductor that is electrically charged.

 The primary circuit is the part connected to the 230V AC mains.

 The secondary circuit is the part powered by the 12V or 24V DC, isolated by the
transformer from the high-voltage mains circuit.
 - -

IEC 60601-2-2

201.12 Accuracy of controls and instruments and protection against hazardous outputs

Abbreviations

SIP/SOP- Signal input/output part

Conductivity test: Assess the cream’s ability to conduct RF energy by applying it to a conductive
material and measuring its conductivity

Heat generation test: Use a thermometer to measure the temperature increase when the cream is
exposed to RF energy

Skin temperature: Monitor the skin temperature during Tecar therapy sessions with both creams
and compare the results

Skin compatibility test: Observe any adverse reactions, such as redness, irritation or allergic
responses, and compare the occurrence between the 2 creams

Apply 100ml of Fiab RF cream to a conducting material & set the intensity @ 20%, 40%, 60%, 80% &
100% & record the time duration for each intensity when the cream dries out

Apply 100ml of Competitor RF cream to a conducting material & set the intensity @ 20%, 40%, 60%,
80% & 100% & record the time duration for each intensity when the cream dries out