Rigel Medical, Bracken Hill, South West Industrial Estate,

Peterlee, County Durham, SR8 2SW United Kingdom

Seaward, Clare, Rigel Medical,
Tel: +44 (0) 191 587 8730 Fax: +44 (0) 191 586 0227 Cropico, Seaward Group USA
Email: sales@rigelmedical.com Web: www.rigelmedical.com are all part of the Seaward Group

Tried. Tested. Trusted.

A Practical guide
to IEc 62353
 Tried. Tested. Trusted.

Table of Contents
Foreword 6
1. Introduction to IEC 62353 6
2. How does IEC 62353 compare with IEC 60601? 6
2.1. IEC 60601 7
2.2. In-Service Test Requirements 7
2.3. Technical Considerations 8
2.4. Preparation Vital 8
3. Commonly used definitions within IEC 60601 – IEC 62353 9
4. Symbols and Markings 10
5. Visual inspection 11
6. Earthbond Testing 11
6.1. Earthbond Test Consideration 12
7. Insulation Resistance Test 12
7.1. Insulation Resistance EUT to Earth 12
7.2. Insulation Resistance Applied Parts 13
7.3. Insulation Resistance Applied Parts to Mains 13
8. IEC 62353 Leakage Measurements 14
8.1. Method Characteristics 14
8.1.1. Direct Leakage Provides: 14
8.1.2. Differential method 15
8.1.3. Alternative method 16
8.2. IEC 601 Body Model 16

Biomed testing on the move. 8.3.

8.3.1.
8.3.2.
Equipment Leakage
Equipment Leakage Direct method
Equipment Leakage Differential method
17
17
18
If you need it with you on-site, the Med-eKit Test Trolley will carry it. 8.3.3. Equipment Leakage Alternative method 19
8.4. Applied Part Leakage 20
8.4.1. Applied Part Leakage Direct method: 21
The Rigel Med-eKit is huge on technical features that make your work Our Rigel Med-eKit can house: 8.4.2. Applied Part Leakage Alternative method; 22
■ Electrical Safety Analyzer (288) 9. Record Keeping 23
more efficient and accurate. But as you can see from the picture above,
■ NIBP Simulator (BP-Sim) 10. Conclusion 24
each of our individual testers is small in size. So small in fact, that ■ SpO2 Simulator (OXY-Sim) 10.1. Considerations and Recommendations; 24
we’ve fit them neatly into a compact, durable trolley case that keeps ■ Patient Simulator Appendix A Pass/Fail limits of IEC 62353 25
■ Flow Analyzer Appendix B IEC 60601-1 Measuring Device 25
everything safe and sound. It’s also got wheels and an extendable
■ Defib Analyzer Appendix C IEC 60601-1 Collateral Standards 26
handle, making getting around site a breeze. The Med-eKit can also ■ Printer & Barcode Scanner Appendix D IEC 60601-2 Particular Standards 26
be fully customized to accomodate your existing test equipment. ■ Asset Management Software Appendix E Patient environment 29
Products in the Rigel Medical range 30

For a no obligation quote: visit www.rigelmedical.com

call +44 (0) 191 587 8730 or email us at sales@rigelmedical.com Tried. Tested. Trusted.
 Tried. Tested. Trusted.

We know about complying to

IEC 62353. After reading
this booklet, so will you.
For over thirty years Rigel Medical has been accessories, test and measurement data
at the forefront of designing and management software, calibration and
manufacturing the most technologically servicing as well as information on industry
advanced biomedical and measurement regulations and testing procedures.
equipment available.
The results for our clients are simple; more
Our services and products are specifically efficient working, greater productivity and
designed to assist medical physics staff, safer medical equipment.
biomedical and service engineers, and
medical device manufacturers to comply with It is effective and it works. Just ask the British
strict regulatory guidelines imposed for Ministry of Defence. Or the National Health
medical devices. Service. Or any of our international clients.

We take a holistic approach, offering much For further information, full product
more than just testers. We call it ‘Total Solutions.’ specifications or to find your nearest Rigel
It incorporates all aspects of test and dealer, visit www.rigelmedical.com or call
measurement procedures and includes + 44 (0) 191 587 8730.

Visit the Rigel Medical website for a

in-depth resource and up to date news on
www.rigelmedical.com Rigel’s products:

■ Product Information
■ Latest News
■ Software Downloads
■ Instruction Manuals
■ E-Newsletter

4 5
 Tried. Tested. Trusted.

FOREWORD it as the basis for regular testing of medical countries. Examples are EN 60601 (EC), ES
This booklet is written as a guideline for people involved in testing medical electrical equipment devices or after service or repair. 60601, UL2601-1 (USA), CSA C22.2 (Canada)
and cannot be considered to replace the IEC 62353 standard. and AS/NZ 3200-1 (Australia/ New Zealand).
However this is likely to change with the
Although all reasonable care has been taken to ensure accuracy of the information and reference introduction of the proposed IEC 62353 which is Clearly, safety testing at the design stage and at
figures and data have been taken from the latest versions of various standards, guidance notes currently being developed by the IEC to the end of the production line is vitally important,
and recognised ‘best practices’ to establish the recommended testing requirements, Rigel specifically describe the test requirements for the but what about when the equipment enters
Medical, their agents and distributors, accept no responsibility for any error or omissions within in-service testing of medical devices. service? In the absence of a recognised
this booklet, or for any misinterpretations by the user. For clarification on any part of this booklet international standard for in-service testing, a
please contact Rigel Medical before operating any test instrument. So what will the implications of IEC 62353 be number of countries have already introduced
and how will it differ from the very well their own national test recommendations.
No part of this publication shall be deemed to form, or be part of any contract for training or established and widely understood requirements
equipment unless specifically referred to as an inclusion within such contract. of IEC 60601? For example, some countries have produced
their own technical standards or guidelines for
Rigel Medical assumes that the readers of this booklet are electronically technically competent and 2.1. IEC 60601 safety testing of newly delivered medical devices
therefore does not accept any liability arising from accidents or fatalities resulting directly or Introduced by the International Electrotechnical (sometimes referred to as acceptance testing),
indirectly from the tests described in this booklet. Committee to govern the design and others have specified the tests at regular
development of medical equipment, the intervals, (also referred to as preventive
international safety standard IEC 60601 Medical maintenance) and some have testing
Electrical Equipment – General Requirements for requirements directly following service or repair.
Safety was first published in 1977 and became Some examples are MDA DB9801 (UK), VDE
1. INTRODUCTION TO IEC 62353 Importantly, the new standard recognises that widely known in shorthand form as IEC 601. 750/751 (Germany), AS/NZ 3551 (Australia/New
the laboratory conditions described in the IEC Zealand), NFPA-99 (USA).
As its full name implies, IEC 62353 Medical 60601-1 cannot always be guaranteed when in- Manufacturers of medical equipment are
Electrical Equipment – recurrent test and test service testing of medical devices is undertaken. required to test to IEC 601 to ensure that the In essence all these standards are linked by the
after repair of medical electrical equipment, is As a result, test measurements that require design of the equipment is intrinsically safe. The aim to control the safety of medical devices used
proposed to define the requirements of ensuring certain environmental conditions may not always standard specifies the type testing requirements the treatment, care and diagnosis of patients and
the in-service electrical safety of electromedical be applicable or consistent for the testing of for protection against potential electric hazards or individuals.
equipment and systems. equipment that is already in use. Another factor including protective Earthing (Earth continuity),
raised is that equipment could potentially be Earth leakage currents, patient leakage current However, in those countries without any national
The IEC 62353 standard is an attempt to damaged by applying type test specifications and patient auxiliary currents. guidance or code of practice on in-service
harmonise the various local standards and when in service and could therefore represent a testing, the convention has been to follow the
practices to ensure safe operation and testing of potential danger to users. As a type testing standard it describes a range of manufacturer’s instructions which invariably
ME Equipment and ME systems. measures that are intended to prove the safety of require that IEC 60601-1 test requirements and
2. HOW DOES IEC 62353 COMPARE an item of electromedical equipment during its limits be repeated.
In meeting this requirement the IEC 62353 WITH IEC 60601? expected useful life. These measures include a
incorporates tests beyond those of type testing. combination of stress and destructive tests that 2.2. IN-SERVICE TEST REQUIREMENTS
Specifically it seeks to provide a uniform and Although IEC 60601 is a type test standard must be undertaken under certain environmental As a type testing electro-technical standard, the
unambiguous means of assessing the safety of governing the safety of the design and conditions. current IEC 60601-1 does not provide any
medical equipment, whilst maintaining the manufacture of medical electrical equipment, guidance in harmonising test requirements once
relation to IEC 60601-1 and minimising the risks most biomedical and clinical engineering In many cases IEC 60601 has been translated an item of medical electrical equipment leaves
to the person conducting the assessment. departments and medical service companies use into local national standards for use in certain the production line.

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 Tried. Tested. Trusted.

Once a medical device enters into service, a 200mA instead of the required 25A in IEC 60601-1. 3. COMMONLY USED DEFINITIONS WITHIN Type BF Applied Part
number of potential test scenarios arise. IEC 60601 – IEC 62353 F-Type Applied Part complying with a higher
In terms of assessing leakage currents, IEC degree of protection against electric shock than
These are: 62353 incorporates a number of different Equipment Under Test type B Applied Parts. Type BF Applied Parts are
measurement methods to help guarantee safer The equipment (EUT) which is the subject of those parts not suitable for direct cardiac
Acceptance Test also referred to as an Initial or practice and the repeatability of measurements. testing. application.
Reference Test. This test is carried out prior to a
new medical device being authorised for use and In addition to the direct leakage method as used Device Under Test Type CF Applied Part
is undertaken to ensure correct and complete in IEC 60601-1, IEC 62353 also provides for The equipment (DUT) which is the subject of F-Type Applied Part complying with the highest
delivery. Acceptance Testing is often not limited differential leakage measurement (also referred to testing. degree of protection against electric shock. Type
to an electrical safety test, with some basic as residual current in some standards) and the CF Applied Parts are those parts suitable for direct
function tests being applied to verify correct ‘alternative’ method. All these tests offer a variety Applied Part cardiac application.
performance. of advantages and disadvantages. (See 8.1 for Part of the medical equipment which is designed
more details). to come into physical contact with the patient or Medical Electrical Equipment
Routine Testing also referred to as PPM, parts that are likely to be brought into contact Electrical equipment designed for treatment,
Preventative Product Maintenance. This form of 2.4. PREPARATION VITAL with the patient. monitoring or diagnoses of patients, powered
testing is often conducted at fixed time intervals, Although the new IEC 62353 standard and local from not more than one connection to mains
which vary between types of equipment, adaptations are expected to be published in Patient Connection supply and which are not necessarily in physical
manufacturer’s recommendations and risk 2007, all involved in the planning, management Individual physical connections and / or metal or electrical contact with the patient or transfers
assessment procedures undertaken by individual and implementation of electrical safety testing parts intended for connection with the patient energy to or from the patient or detects such
BME or medical physics departments. Routine procedures for medical equipment should start which form (part of) an Applied Part. energy transfer to or from the patient.
testing is not limited to safety testing and often to think about the possible implications now.
includes the verification of correct functionality. Patient Environment Medical Electrical System
Although the onus will inevitably fall on the Volumetric area in which a patient can come into Combination of equipment of which at least one
After Service & Repair Testing is carried out manufacturers of medical devices to advise on contact with medical equipment or contact can is classed as medical electrical equipment and is
following a repair or product upgrade. It is often appropriate in-service test procedures for their occur between other persons touching medical specified by the manufacturer to be connected
part of a service carried out by in-hospital own equipment, the new standard will clearly equipment and the patient, both intentional and by functional connection or use of a multiple
mechanical or clinical engineering teams. In have an impact on medical service companies, unintentional (see Appendix E). portable socket-outlet.
many cases, more rigorous electrical safety Biomed’s, medical physics, clinical engineering
testing is needed after the replacement of and other technical departments. F-Type Applied Part Class I
components or reconfiguration of medical Applied Part which is electrically isolated from Equipment protection against electric shock by
devices. To help all those likely to be affected by the Earth and other parts of the medical equipment (Earthed) additional protection to basic insulation
introduction of the new IEC 62353 standard, a i.e. floating F-type Applied Parts are either type through means of connecting exposed
2.3. TECHNICAL CONSIDERATIONS summary of the test requirements is provided in BF or type CF Applied Parts. conductive parts to the protective Earth in the
The main aim of IEC 62353 is to provide a uniform this IEC 62353 guidance booklet. This guidance fixed wiring of the installation.
standard that ensures safe practice and reduces booklet is intended for general information only Type B Applied Part
the complexity of the current IEC 60601-1 and is not intended for use as a replacement of Applied Part complying with specified Class II
standard. the full version of the standard. requirements for protection against electric Also referred to as Double Insulated. Equipment
shock. Type B Applied Parts are those parts, protection against electric shock by additional
For example, one of the main differences will be in which are usually Earth referenced. Type B are protection to basic insulation through means of
Earthbond testing, where the new standard will those parts not suitable for direct cardiac supplementary insulation are provided, there
specify a minimum Earthbond test current of application. being no provision for the connection of exposed

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 Tried. Tested. Trusted.

metalwork of the equipment to a protective For the purpose of this booklet, a selection of the 5. VISUAL INSPECTION additional metal accessible parts on the
conductor and no reliance upon precautions to most commonly used symbols is displayed enclosure.
be taken in the fixed wiring of the installation. below: The process of visual inspection is not clearly
defined by IEC 60601, however visual The test current is applied between the Earth pin
NOTE: CLASS II EQUIPMENT MAY BE PROVIDED Class I inspections form a critical part of the general of the mains supply plug and any accessible
WITH A FUNCTIONAL EARTH TERMINAL OR A safety inspections during the functional life of metal part (including Earth reference point) via a
FUNCTIONAL EARTH CONDUCTOR. medical equipment. In most cases, 70% of all dedicated Earthbond test lead (clip/probe).
faults are detected during visual inspection. Figure 1 shows a representation of the
4. SYMBOLS AND MARKINGS Class II Visual inspection is a relatively easy procedure to Earthbond test.
make sure that the medical equipment in use still
The IEC 60601 has defined the requirements for conforms to the specifications as released by the
information / data to be present on the medical manufacturer and has not suffered from any
equipment’s nameplate, in order to form an Earth Reference point external damage and/or contamination.
unambiguous identification of the equipment.
Information must include: Manufacturer’s name, These can include the following inspections:
model number, serial number, electrical
requirements etc. i.e. “Conformité Européenne” • Housing Enclosure – Look for damage, cracks
etc
The IEC 60601 standard refers to a large variety • Contamination – Look for obstruction of
of symbols for use on medical equipment, moving parts, connector pins etc
medical systems, accessories and other related Type B Applied Part • Cabling (supply, Applied Parts etc) – Look for
parts. A full overview of the symbols used in IEC cuts, wrong connections etc
60601 is provided in the standard, table D1. • Fuse rating – check correct values after Figure 1: Earthbond test in Class I equipment
replacement For fixed installations a Point-to-Point continuity
Defibrillation proof type B Applied Part • Markings and Labelling – check the integrity measurement can be made by fitting a second
of safety markings lead into the Aux Earth socket. The resistance is
• Integrity of mechanical parts – check for any then measured between the two leads.
obstructions
Type BF Applied Part
The IEC 62353 requires a minimum test current
6. EARTHBOND TESTING of 200mA, either AC or DC. When using a DC
test current, the resistance must be tested in
Defibrillation proof type BF Applied Part Earthbond Testing, also referred to as both polarities of the test current. The highest
Groundbond Testing, tests the integrity of the low reading will determine the PASS or FAIL result of
resistance connection between the earth this test.
conductor and any metal conductive parts,
Type CF Applied Part which may become live in case of a fault on The open circuit voltage of the current source
Class I medical devices. should not exceed 24V.

Although many Class I medical devices are The Test limits in IEC 62353 are set to:
supplied with an Earth reference point, most if
100mΩ
Defibrillation proof type CF Applied Part
not all medical devices require multiple for a detachable power cable up to 3
Earthbond tests to validate the connections of metres

10 11
 Tried. Tested. Trusted.

300mΩ for a Class I device including power 7.1. INSULATION RESISTANCE EUT TO 7.2. INSULATION RESISTANCE APPLIED corresponding terminals of your safety analyser.
cable (not exceeding 3 metres) For Class I equipment, plug the mains plug into
500mΩ
EARTH PARTS
for a Medical System consisting of This test is used to verify that the mains parts are This test is used to verify that the Applied Parts the safety analyser. Class II Equipment requires
several Medical and Non-Medical adequately insulated from Earth (Class I) or the are adequately insulated from Earth (Class I) or an auxiliary lead to be connected to the
pieces of Equipment. See definition of Enclosure (Class II). Figures 2A and 2B show a the Enclosure (Class II). This test is applicable to enclosure of the equipment. This can be done by
Medical System in IEC 60601-1: 2005 representation of the Insulation Test. Class I and Class II, BF and CF equipment only. wrapping the enclosure in aluminium foil and
Figures 3A and 3B show a representation of this connecting to the auxiliary lead via an alligator clip.
6.1. EARTHBOND TEST CONSIDERATION Insulation test.
High Test Currents (10A or more) might 7.3. INSULATION RESISTANCE APPLIED
potentially be destructive to parts of the DUT PARTS TO MAINS
which are connected to the protective Earth This test is used to verify that the Applied Parts
but have a functional purpose (e.g. screening). Riso are adequately insulated from the mains parts
As such, consideration should be given to the and is applicable to Class I and Class II BF and
test current. CF equipment only. Figure 4 show a
representation of the Applied Parts to Mains
Low Test Currents (<8A) could potentially Insulation test.
influence the reading as contact resistance is Figure 2A: Insulation EUT Test on Class I equipment
influenced by a number of factors (Constriction,
Pressure, Film resistance). Higher Test Currents
overcome the contact resistance where lower
currents show a relatively higher reading, thus Figure 3A: Insulation AP Test on Class I equipment
potentially causing unnecessary failures.

More on High vs Low Test Currents can be

obtained in an application note on Earthbond
testing. Simply email info@rigelmedical.com to
receive your free copy.

7. INSULATION RESISTANCE TEST Figure 2B: Insulation EUT Test on Class II equipment Figure 4: Insulation AP to Mains Test on Class I and
Class II equipment
Unlike the standard IEC 60601-1 tests, the IEC During this test, 500V D.C. is applied between
62353 does provide a method of testing the the Earth pin and both the Live and Neutral During this test, 500V D.C. is applied between
Insulation of the Medical Device. pins of the appliance mains supply plug. all the Applied Parts combined and both the
The methods of testing insulation are separated Figure 3B: Insulation AP Test on Class I equipment live and neutral pins of the appliance mains
into: For both Class I and Class II appliances plug supply plug.
• Insulation between Mains Parts and Earth (7.1) the DUT into the Safety Analyser. Class II During this test, 500V D.C. is applied between
• Insulation between Applied Parts and Earth (7.2) equipment requires an auxiliary lead to be the Earth pin (Class I) or the Enclosure (Class For both Class I and Class II appliances, connect
• Insulation between Mains Parts and Earth (7.3) connected to the enclosure of the equipment. II) and all the Applied Parts combined. the Patient Connections or Applied Parts to the
This can be done by wrapping the enclosure corresponding terminals of your safety analyser
in aluminium foil and connecting to the For both Class I and Class II appliances, connect and connect the mains plug into the safety
auxiliary lead via an alligator clip. the Patient Connections or Applied Parts to the analyser.

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 Tried. Tested. Trusted.

8. IEC 62353 LEAKAGE MEASUREMENTS set stringent rules on the design of medical Benefits ensure that the measurements are done at
equipment so as to prevent any patient or • Means of measuring both AC and DC maximum Live to Earth voltage. Any voltage
Research has shown that current not voltage is operator being exposed to currents not part of leakage current between Neutral and Earth might result in a
often the source of injury or death. It takes only a the functional operation of the device. These lower reading, potentially passing faulty
small amount of current to cause major currents are referred to as leakage currents. • Highest accuracy compared to other equipment
consequences. methods
IEC 62353 defines two different kinds of Leakage 8.1.2. Differential method
When an electrical current flows through the Current Tests; • Potential leakage through a human body via The Differential Leakage Method measures the
human body the effect is influenced by two main measuring device leakage current as a result of an imbalance in
factors. Firstly the amount of current and • Equipment Leakage Current – total leakage current between the Live conductor and the
secondly the length of time the current flows. deriving from the Applied Parts, Enclosure • Direct comparison with measurements made Neutral conductor.
and Mains Parts combined to real Earth in accordance with IEC 60601-1
For example, the heart stops if the current Potential secondary Earth connections are
persists for: • Applied Part Leakage Current – total included in the total measurement and the EUT
• The 1kΩ resistor forming
To consider
leakage deriving from the combined Patient the Measuring doesn’t need to be positioned in isolation from
a) 250mS at 40mA Connections within an Applied Part to Earth Device is interrupting the low resistance Earth.
b) 100mS at 100mA and any conductive or non conductive parts Protective Earth Conductor, thus causing a
c) 50mS at 200mA on the enclosure potential hazard when testing faulty Low leakage currents of less than 75µA are
equipment difficult to measure using the Differential Leakage
Consider the following examples of the effect of The IEC 62353 describes the following methods method. The Differential Leakage method is
current on the human body when applied to the to measure these Leakage Currents; • Secondary Earth path(s). The EUT / DUT deemed unsuitable for measuring conductive
skin (non invasive); must be positioned electrically isolated from Un-Earthed parts and in those instances where
• Direct Leakage; Current flowing down the Earth during the measurement. A lower leakages are expected to be below 75µA.
0.9–1.2mA Current just perceptible protective Earth conductor of the mains inlet lead leakage might be measured as not all
leakage is measurable in the earth conductor Benefits
15.0–20.0mA Release impossible: cannot • Differential Leakage; The result of • The measurements are not influenced by
be tolerated over 15 minutes imbalance in current between the Live • Secondary connections are typical with: secondary Earth connections
conductor and the Neutral conductor – Equipment bolted to steel enforced
50.0–100.0mA Ventricular fibrillation, concrete floor (e.g. dentist chairs, MRI) • It measures the total equipment leakage
respiratory arrest, leading • Alternative Method; Current flowing through – Equipment connected to gas or water current
directly to death a person to earth from the Applied Part or supply
current flowing from a person to Earth via the – Equipment that is part of a Medical • The Measuring Device (1kΩ resistor) is no
100.0–200.0mA Serious burns and muscular Applied Part by applying unintended voltage Electrical System longer in series with the Earth conductor,
contraction of such a degree from an external source – Equipment connected to PC / Printer thus providing a low resistance Protective
that the thoracic muscles Earth
constrict the heart 8.1. METHOD CHARACTERISTICS • A difference in Polarity of the Live and Neutral
8.1.1. Direct Leakage Provides: conductors might alter the leakage readings, To consider
Compare these values to the fact that 250mA of The Direct Leakage Method is identical to the as such leakage measurements must be • The Differential Leakage measurement is less
current is required to power a 25 watt lamp. method used in the IEC 60601-1 standard, done in each polarity of mains supply suitable to accurately measure lower leakage
measuring the true leakage through a body currents (<100µA)
For this reason, the IEC 60601 committee has model (Measuring Device) to Earth. • A TN (Terre – Neutral) system is required to

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 Tried. Tested. Trusted.

• The measurements can be influenced by • The DUT is disconnected from the mains thus 8.3. EQUIPMENT LEAKAGE
L(N) MP AP
external magnetic fields or the analyser’s own providing a high level of safety for the test The Equipment Leakage Test measures the total
internal magnetic fields engineer leakage deriving from the Applied Parts,
Enclosure and Mains Parts combined to Real
• The measurements can be influenced by high • TN-System is not required due to mains free Earth. The Equipment Leakage Test is applicable N(L)

current consumption of the DUT application to Class I and II, B, BF and CF equipment.
MD
• The measurements have limited frequency • Measurements are not influenced by Leakage measurements to IEC 62353 are done
response secondary earth connections using the RMS value instead of the separate AC Figure 5B: Equipment Leakage Direct – Class II
and DC values used in the IEC 60601-1 standard.
• A difference in Polarity of the Live and Neutral • Tests can be performed from a battery The DUT must be positioned floating to avoid
conductors might alter the leakage readings. powered instrument The IEC 62353 specifies three different methods secondary Earth connections influencing the
Leakage measurements must be done in of measuring the Equipment Leakage Current; measuring process.
each polarity of mains supply • Measurements are highly repeatable and
provide a good indication of deterioration in • Direct Method All Applied Parts (B, BF & CF) and Earthed (eg
• Both Direct and Alternative methods provide the dielectrics of the medical device under test • Differential Method enclosure Class I) and Non-Earthed accessible
higher accuracy and broader frequency • Alternative Method conductive parts or non-conductive accessible
response which is required for measuring parts (enclosure Class II) are grouped together
and connected to earth via the 1kΩ Measuring
To consider
trends in low leakage conditions • Equipment will not be activated thus 8.3.1. Equipment Leakage Direct method
preventing the measurement of actual leakage The Direct Method is identical to the method Device (Body Model).
8.1.3. Alternative method currents on equipment with switched circuits used in the IEC 60601-1.
The Alternative Method is similar to a Dielectric The 1kΩ Measuring Device (MD – equivalent to that
Strength Test at mains potential, using a current • The Alternative Method is not directly Figures 5A and 5B show a representation of the used in the IEC 60601 standard – see Appendix B)
limited voltage source at mains frequency. comparable with the IEC 60601 test results Direct Method. is positioned in the leakage return path to Earth.

The Live and Neutral conductors are shorted 8.2. IEC 601 BODY MODEL L(N) MP AP The test is conducted with the protective earth
together and the current limited voltage is To ensure a traceable simulation of current as if connection interrupted to ensure the
applied between the mains parts and other parts passing through a human body, measurement N(L) measurements are done under worst conditions. As
of the equipment. circuits have been designed to simulate the such, any Earth leakage current will be measured as
average typical electrical characteristics of the part of the enclosure (or touch) leakage.
Due to the current limiting resistor(s), the actual human body. These measurement circuits are
measuring voltage is dependent on the test load. referred to as Body Models or Measuring Device Measurements are done in both polarities of the
The measured leakage current is scaled in (MD in IEC 60601-1). MD incoming mains with the protective Earth to the
proportion to the actual output voltage to predict Figure 5A: Equipment Leakage Direct - Class I EUT interrupted.
the actual leakage current flow at full mains Some standards such as the NFPA-99 and the
potential. IEC 61010 (electrical equipment for APPLIED PART
measurement, control and Laboratory use) Current in µA (RMS)
Benefits specify different electrical characteristics to that B BF CF
• As Live and Neutral are combined, the mains of the IEC 60601-1. Equipment leakage – direct or differential method
polarity has no influence. Only one The IEC 60601-1 Body Model or measuring
Class I Equipment 500µA 500µA 500µA
measurement is required device is shown in Appendix B.
Class II Equipment (touch current) 100µA 100µA 100µA

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 Tried. Tested. Trusted.

8.3.2. Equipment Leakage Differential method All Applied Parts (B / BF & CF) and Earthed 8.3.3. Equipment Leakage Alternative method The test is performed using current limited
Figures 6A and 6B show a representation of the (e.g. enclosure Class I) and Non-Earthed This method is in fact similar to a dielectric test (3.5mA) mains potential sinusoidal 50Hz signal
Differential Method. accessible conductive parts or non-conductive between the mains parts and all accessible parts (60Hz where this is the mains frequency).
accessible parts (enclosure Class II) are grouped (conductive and non-conductive) including the
M
together and connected to Earth to allow the Applied Parts connected together. Figures 7A As Live and Neutral are shortened, the DUT is
L(N) MP AP
Differential circuit to measure the total leakage and 7B show a representation of the Alternative not directly connected to the mains potential.
current. Method. Mains reversal is not applicable and the EUT
does not need to be positioned isolated from
N(L) Unlike the Direct Method, the Differential method MP AP Earth.
does not measure via the standard IEC 60601
Body Model in the Earth conductor. The MD is All Applied Parts, Earthed (e.g. enclosure Class
part of a differential current measurement I) and Non-Earthed accessible conductive parts
between the Live and Neutral conductors. The or non-conductive accessible parts (enclosure
frequency response of the measurement is Class II) are grouped together and connected to
the mains parts via the 1kΩ Measuring Device
Figure 6A: Equipment Leakage Differential – Class I
similar to the Body Model used in the IEC 60601.
MD (Body Model) and voltage source.
M The test is conducted with the protective Earth
connection closed for protection of the user. Figure 7A: Equipment Leakage Alternative – Class I The 1kΩ measuring Device (equivalent to that
L(N) MP AP
used in the IEC 60601 standard – see Appendix
Measurements are done in both polarities of the B) is positioned directly after the voltage source.
N(L)
incoming mains with the protective Earth to the MP AP The test is conducted with the protective Earth
EUT interrupted. connection closed for protection of the user.

Low leakage currents of less than 75µA are

difficult to measure using the Differential Leakage
Figure 6B: Equipment Leakage Differential – Class II method. The Differential Leakage method is
Potential secondary Earth connections are unsuitable for measuring conductive Un-Earthed MD
included in the total measurement and the DUT parts and in those instances where leakages are
is not required to be isolated from Earth. expected to be below 75µA. Figure 7B: Equipment Leakage Alternative – Class II

APPLIED PART APPLIED PART

Current in µA (RMS) Current in µA (RMS)
B BF CF B BF CF
Equipment leakage – direct or differential method Equipment leakage – alternative method
Class I Equipment 500µA 500µA 500µA Class I Equipment 1000µA 1000µA 1000µA
Class II Equipment (touch current) 100µA 100µA 100µA Class II Equipment (touch current) 500µA 500µA 500µA

18 19
 Tried. Tested. Trusted.

8.4. APPLIED PART LEAKAGE 8.4.1. Applied Part Leakage Direct method: Each Individual Applied Part is measured in turn
The Applied Part Leakage Test measures the Figures 8A and 8B show a representation of the and grouped with all Earthed (e.g. enclosure Class
total leakage deriving from the combined Patient Direct Method. I) and Non-Earthed accessible conductive parts or
Connections within an Applied Part to Earth and non-conductive accessible parts (enclosure Class
any conductive or non conductive parts on the II). These are grouped together and connected to
enclosure (either connected or isolated from Earth via the 1kΩ Measuring Device (Body Model).
L(N) MP AP AP1
Earth) under the fault condition Mains on Applied
Parts. Applied Parts and Patient Connections not part of
the measurement shall be left floating.
N(L) AP2
The Applied Part Leakage Test is applicable to
Floating type (BF & CF) Applied Parts only The 1kΩ Measuring Device (MD - equivalent to that
either Class I or II. MD used in the IEC 60601 standard – see Appendix B)
is positioned between the Applied Part and Voltage
All Patient Connections of a single function within Source.
an Applied Part shall be connected together (BF Figure 8A: Applied Part Leakage Direct – Class I
& CF) and measured one at the time. The test is conducted with the protective Earth
connection closed for protection of the user.
Applied Parts (and Patient Connections) not part Measurements are done in both polarities of the
of the measurement shall be left floating i.e. not L(N) MP AP AP1 incoming mains with the protective Earth to the
connected to real Earth. EUT interrupted.

The test is conducted by applying a current N(L) AP2 Warning: This Applied Part Direct Leakage test is
limited (3.5mA) mains potential sinusoidal 50Hz similar to that of the F-Type leakage test according
signal (60Hz where this is the mains frequency) to IEC 60601 using an equivalent current limited
MD
between the Applied Part and the Enclosure and voltage source to produce the mains potential. Both
Earth connection of the EUT connected to real sources depend on a current limiting resistor which
Earth. Figure 8B: Applied Part Leakage Direct – Class II could cause a significant voltage drop.

Leakage measurements to IEC 62353 are done The DUT must be positioned floating to avoid Unlike the IEC 60601-1 requirements, the voltage
using the RMS value instead of the separate AC secondary Earth connections influencing the drop caused by the current limiting resistor is
and DC values used in the IEC 60601-1 measuring process. compensated for in the IEC 62353 thus potentially
standard. resulting in a higher reading than the typical IEC
All floating type Patient Connections in each 60601-1 F-type test. Please refer to the
The IEC 62353/Applied Part Leakage can be Applied Part (BF & CF) are connected together. manufacturers recommendations.
performed in two different methods;
• Direct Method
• Alternative Method
APPLIED PART
Current in µA (RMS)
B BF CF
Patient leakage current – direct method (a.c.)
Class I & II 5000µA 50µA

20 21
 Tried. Tested. Trusted.

8.4.2. Applied Part Leakage Alternative method As Live and Neutral are shortened, the DUT is 9. RECORD KEEPING To ensure proper record keeping is maintained it
This method is in fact similar to a dielectric test not directly connected to the mains potential. is important to provide a procedure in which data
between the Applied Part and all mains parts, Therefore, mains reversal is not applicable and Overall, the area of risk assessment and the is collected regarding:
EUT Earth and Enclosure connected together. the EUT does not need to be positioned in creation of risk management files has become a
Figures 9A and 9B show a representation of the isolation from Earth. growing feature of routine safety testing • Inspection Date
Alternative Method. decisions, with different organisations and • Visual Inspection
All floating type Patient Connections in each departments drawing-up individual plans to deal • Electrical Safety
Applied Part (BF & CF) are connected together. with specific safety hazards. Comparison with • Functional Testing
MP AP AP1
Each Individual Applied Part is measured in turn previous test results will therefore allow you to • Next Inspection Date
and connected via the 1kΩ Measuring Device monitor deterioration of the Device Under Test
(Body Model) to the voltage source and Earthed and prevent potential failure before a fault occurs. The IEC 62353 provides a guideline in collecting
AP2
(e.g. enclosure Class I) and Non-Earthed such information with the purpose of developing
accessible conductive parts or non-conductive Electrical safety testing is only part of the total consistency in data collection and management.
accessible parts (enclosure Class II) grouped service carried out on medical equipment. Once By doing so, trends can be monitored to benefit:
MD
together. the safety has been proven, the functionality is
verified and recorded before the equipment is • Identifying common faults
Figure 9A: Applied Part Leakage Alternative – Class I Applied Parts and Patient Connections not part returned for use on patients. • Detect component deterioration (preventative
of the measurement shall be left floating. maintenance)
The 1kΩ Measuring Device (MD - equivalent to This functional testing can be a combination of • Develop efficient re-test periods
MP AP AP1 that used in the IEC 60601 standard – see simulations and functional measurement such as
Appendix B) is positioned between the Applied measuring the output energy of defibrillators, the For the future, determining the appropriate levels
Part and Voltage Source. infusion rate of infusion pumps and syringe of both electrical and functional testing will be
drivers, the flow rate and frequency of ventilators central to the introduction of cost effective yet
AP2
The test is conducted with the protective Earth and the energy output of surgical instruments. reliable preventative maintenance campaigns.
connection closed for the protection of the user. Patient monitors are designed to take a variety of
MD physiological conditions to monitor the patient’s
vital signs. To ensure patient monitors are
Figure 9B: Applied Part Leakage Alternative – Class II displaying the correct readings, a verification of
the individual parameters is required.

Such verifications are typically done by

specialised equipment such as an Oxygen
Saturation Simulator (SPO2), Non-Invasive Blood
Pressure (NIBP) Simulator, Temperature
Simulator, ECG Simulator, Ventilator Tester,
Infusion Pump Tester etc.
APPLIED PART
Current in µA (RMS)
B BF CF
Patient leakage current – alternative method (a.c.)
Class I & II 5000µA 50µA

22 23
 Tried. Tested. Trusted.

10. CONCLUSION 4. Ensure high accuracy and repeatability of APPENDIX A: PASS/FAIL LIMITS OF IEC 62353
leakage measurement readings (some
Electrical safety testing of medical electronic manufacturers might specify full scale APPLIED PART
Current in µA (RMS)
devices remains a crucial part of the overall accuracy which will affect the accuracy of low B BF CF
safety validation of medical devices and requires leakage measurements) Equipment Leakage – alternative method
specialised test equipment. Class I Equipment 1000µA 1000µA 1000µA
5. Ensure that contact resistance is taken into Class II Equipment 500µA 500µA 500µA
The IEC 62353 standard will provide; account when measuring the Earth continuity Equipment leakage – direct or differential method
at low currents (<8A). Contact resistance can Class I Equipment 500µA 500µA 500µA
• Global test reference to allow uniform testing influence the readings and cause Class II Equipment (touch current) 100µA 100µA 100µA
• Development tools for saver and suitable test unnecessary failures of the Device Under Patient leakage current – alternative method (AC)
sequences Test. Ask for an application note on low Class I & II 5000µA 50µA
• A method of record keeping and current testing via info@rigelmedical.com Patient leakage current – direct method (AC)
maintenance procedures (subject: low current testing) Class I & II 5000µA 50µA
NOTE 1: This IEC 62353 standard does not provide measuring methods and allowable values for equipment producing DC leakage
When choosing your future electrical safety 6. When determining the correct means of currents. In such a case the manufacturer should give information in accompanying documents.
analyser, ensure that it can be used to test in testing a specific item of Medical Equipment, NOTE 2: Particular standards may allow different values of leakage current. For a list of particular standards, please refer to Appendix D.
accordance with the IEC 62353 requirements ensure that the chosen safety test
and secondly that your analyser will enable you procedures are applicable to the Device
to accurately and repeatedly produce the results Under Test and are clearly documented for APPENDIX B: IEC 60601-1 MEASURING DEVICE
you require. future use +20

Z(ƒ-10)
Z(ƒ)
10.1 CONSIDERATIONS AND Rigel Medical offers a range of test 0
RECOMMENDATIONS equipment in line with IEC 62353 and IEC R1

Relative magnitudec) (db): 20 log

60601 requirements. Please visit our website Voltage
-20
1. Ensure that the operator of the safety test www.rigelmedical.com for a full overview of Z R2 C1 V measuring
instrumentb)
equipment is properly trained on both the our product offering or register online for our
safety analyser and Device Under Test to free newsletter on future product releases -40

prevent unneccessary danger during the and product innovations.

safety test -60
For further questions or comments relating to R1 = 10k Ω ±5%a)
2. Always ensure that the Device Under Test this booklet or the Rigel Medical product R2 = 1k Ω ±5%a)
C1 = 0.015 µF ±5%
does not pose any danger to the user and/or offering, please contact John Backes at 10 102 103 104 105 106
people within the vicinity to the safety test johnb@seaward.co.uk Frequency (ƒ) in Hz
(e.g. moving parts, open conductors, Live a) Measuring Device b) Frequency Characteristics
components, heat etc.)
Note: The network and voltage measuring instrument above is replaced by the symbol MD in the
following figures.
3. Ensure that Leakage Measurements are
performed whilst the equipment is in full a)
Non-inductive components
operation mode, including its sub-systems or b)
Impedance >> measuring impedance Z
components
c)
Z(ƒ) is the transfer impedance of the network, i.e. Vout/in, for a current frequency ƒ.

Example of a measuring device MD according to IEC 60601-1 and its frequency characteristics

24 25
 Tried. Tested. Trusted.

APPENDIX C: IEC 60601-1 COLLATERAL STANDARDS APPENDIX D: IEC 60601-2 PARTICULAR STANDARDS IEC 60601-2-12 MEDICAL ELECTRICAL EQUIPMENT – PART IEC 60601-2-25 MEDICAL ELECTRICAL EQUIPMENT – PART
2: PARTICULAR REQUIREMENTS FOR THE 2-25: PARTICULAR REQUIREMENTS FOR THE
(© IEC Geneva, Switzerland) (© IEC Geneva, Switzerland) SAFETY OF LUNG VENTILATORS FOR SAFETY OF ELECTROCARDIOGRAPHS
MEDICAL USE
IEC 60601-1-1 MEDICAL ELECTRICAL EQUIPMENT – PART IEC 60601-2-1 MEDICAL ELECTRICAL EQUIPMENT – PART IEC 60601-2-26 MEDICAL ELECTRICAL EQUIPMENT PART 2:
1: GENERAL REQUIREMENTS FOR SAFETY 1: 2-1: PARTICULAR REQUIREMENTS FOR THE IEC 60601-2-13 MEDICAL ELECTRICAL EQUIPMENT – PART PARTICULAR REQUIREMENTS FOR THE
COLLATERAL STANDARD: SAFETY SAFETY OF ELECTRON ACCELERATORS IN 2-13: PARTICULAR REQUIREMENTS FOR THE SAFETY OF ELECTROENCEPHALOGRAPHS
REQUIREMENTS FOR MEDICAL ELECTRICAL THE RANGE 1 MEV TO 50 MEV SAFETY OF ANAESTHETIC WORKSTATIONS
SYSTEMS IEC 60601-2-27 MEDICAL ELECTRICAL EQUIPMENT – PART
IEC 60601-2-2 MEDICAL ELECTRICAL EQUIPMENT – PART IEC 60601-2-14 MEDICAL ELECTRICAL EQUIPMENT – PART 2: PARTICULAR REQUIREMENTS FOR THE
IEC 60601-1-2 MEDICAL ELECTRICAL EQUIPMENT – PART 2-2: PARTICULAR REQUIREMENTS FOR THE 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF ELECTROCARDIOGRAPHIC
1: GENERAL REQUIREMENTS FOR SAFETY 2. SAFETY OF HIGH FREQUENCY SURGICAL SAFETY OF ELECTROCONVULSIVE THERAPY MONITORING EQUIPMENT
COLLATERAL STANDARD: EQUIPMENT EQUIPMENT
ELECTROMAGNETIC COMPATIBILITY IEC 60601-2-28 MEDICAL ELECTRICAL EQUIPMENT – PART
–REQUIREMENTS AND TESTS IEC 60601-2-3 MEDICAL ELECTRICAL EQUIPMENT PART 2: IEC 60601-2-15 MEDICAL ELECTRICAL EQUIPMENT – PART 2: PARTICULAR REQUIREMENTS FOR THE
PARTICULAR REQUIREMENTS FOR THE 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF X-RAY SOURCE ASSEMBLIES
IEC 60601-1-3 MEDICAL ELECTRICAL EQUIPMENT – PART SAFETY OF SHORT-WAVE THERAPY SAFETY OF CAPACITOR DISCHARGE X-RAY AND X-RAY TUBE ASSEMBLIES FOR
1: GENERAL REQUIREMENTS FOR SAFETY – EQUIPMENT GENERATORS MEDICAL DIAGNOSIS
COLLATERAL STANDARD: GENERAL
REQUIREMENTS FOR RADIATION IEC 60601-2-4 MEDICAL ELECTRICAL EQUIPMENT PART 2: IEC 60601-2-16 MEDICAL ELECTRICAL EQUIPMENT – PART IEC 60601-2-29 MEDICAL ELECTRICAL EQUIPMENT – PART
PROTECTION IN DIAGNOSTIC X-RAY PARTICULAR REQUIREMENTS FOR THE 2: PARTICULAR REQUIREMENTS FOR THE 2-29: PARTICULAR REQUIREMENTS FOR THE
EQUIPMENT SAFETY OF CARDIAC DEFIBRILLATORS AND SAFETY OF HAEMODIALYSIS EQUIPMENT SAFETY OF RADIOTHERAPY SIMULATORS
CARDIAC DEFIBRILLATORS MONITORS
IEC 60601-1-4 MEDICAL ELECTRICAL EQUIPMENT: PART 1- IEC 60601-2-17 MEDICAL ELECTRICAL EQUIPMENT – PART IEC 60601-2-30 MEDICAL ELECTRICAL EQUIPMENT – PART
4: GENERAL REQUIREMENTS FOR IEC 60601-2-5 MEDICAL ELECTRICAL EQUIPMENT – PART 2: PARTICULAR REQUIREMENTS FOR THE 2-30: PARTICULAR REQUIREMENTS FOR THE
COLLATERAL STANDARD: PROGRAMMABLE 2-5: PARTICULAR REQUIREMENTS FOR THE SAFETY OF REMOTE-CONTROLLED SAFETY, INCLUDING ESSENTIAL
ELECTRICAL MEDICAL SYSTEMS SAFETY OF ULTRASONIC PHYSIOTHERAPY AUTOMATICALLY DRIVEN GAMMARAY PERFORMANCE, OF AUTOMATIC CYCLING
EQUIPMENT AFTER-LOADING EQUIPMENT NON-INVASIVE BLOOD PRESSURE
IEC 60601-1-6 MEDICAL ELECTRICAL EQUIPMENT - PART MONITORING EQUIPMENT
1-6: GENERAL REQUIREMENTS FOR BASIC IEC 60601-2-6 MEDICAL ELECTRICAL EQUIPMENT – PART IEC 60601-2-18 MEDICAL ELECTRICAL EQUIPMENT PART 2:
SAFETY AND ESSENTIAL PERFORMANCE - 2: PARTICULAR REQUIREMENTS FOR THE PARTICULAR REQUIREMENTS FOR THE IEC 60601-2-31 MEDICAL ELECTRICAL EQUIPMENT – PART
COLLATERAL STANDARD: USABILITY SAFETY OF MICROWAVE THERAPY SAFETY OF ENDOSCOPIC EQUIPMENT 2: PARTICULAR REQUIREMENTS FOR THE
EQUIPMENT SAFETY OF EXTERNAL CARDIAC
IEC 60601-1-8 MEDICAL ELECTRICAL EQUIPMENT - PART IEC 60601-2-19 MEDICAL ELECTRICAL EQUIPMENT – PART PACEMAKERS WITH INTERNAL POWER
1-8: GENERAL REQUIREMENTS FOR BASIC IEC 60601-2-7 MEDICAL ELECTRICAL EQUIPMENT – PART 2: PARTICULAR REQUIREMENTS OF SAFETY SOURCE
SAFETY AND ESSENTIAL PERFORMANCE - 2-7: PARTICULAR REQUIREMENTS FOR THE OF BABY INCUBATORS
COLLATERAL STANDARD: GENERAL SAFETY OF HIGH-VOLTAGE GENERATORS OF IEC 60601-2-32 MEDICAL ELECTRICAL EQUIPMENT PART 2:
REQUIREMENTS, TESTS AND GUIDANCE FOR DIAGNOSTIC X-RAY GENERATORS IEC 60601-2-20 MEDICAL ELECTRICAL EQUIPMENT – PART PARTICULAR REQUIREMENTS FOR THE
ALARM SYSTEMS IN MEDICAL ELECTRICAL 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF ASSOCIATED EQUIPMENT OF X-
EQUIPMENT AND MEDICAL ELECTRICAL IEC 60601-2-8 MEDICAL ELECTRICAL EQUIPMENT – PART SAFETY OF TRANSPORT INCUBATORS RAY EQUIPMENT
SYSTEMS 2-8: PARTICULAR REQUIREMENTS FOR THE
SAFETY OF THERAPEUTIC X-RAY IEC 60601-2-21 MEDICAL ELECTRICAL EQUIPMENT PART 2: IEC 60601-2-33 MEDICAL ELECTRICAL EQUIPMENT – PART
IEC 60601-1-9 (CDIS) MEDICAL ELECTRICAL EQUIPMENT - PART EQUIPMENT OPERATING IN THE RANGE 10 PARTICULAR REQUIREMENTS FOR THE 2: PARTICULAR REQUIREMENTS FOR THE
1-9: GENERAL REQUIREMENTS FOR BASIC KV TO 1 MV SAFETY OF INFANT RADIANT WARMERS SAFETY OF MAGNETIC RESONANCE
SAFETY AND ESSENTIAL PERFORMANCE - EQUIPMENT FOR MEDICAL DIAGNOSIS
IEC 60601-2-9 MEDICAL ELECTRICAL EQUIPMENT – PART IEC 60601-2-22 MEDICAL ELECTRICAL EQUIPMENT – PART
COLLATERAL STANDARD: REQUIREMENTS
2: PARTICULAR REQUIREMENTS FOR THE 2: PARTICULAR REQUIREMENTS FOR THE IEC 60601-2-34 MEDICAL ELECTRICAL EQUIPMENT – PART
FOR ENVIRONMENTALLY CONSCIOUS
SAFETY OF PATIENT CONTACT SAFETY OF DIAGNOSTIC AND THERAPEUTIC 2: PARTICULAR REQUIREMENTS FOR THE
DESIGN
DOSEMETERS USED IN RADIOTHERAPY LASER EQUIPMENT SAFETY, INCLUDING ESSENTIAL
IEC 60601-1-10 (ADIS) MEDICAL ELECTRICAL EQUIPMENT - PART WITHELECTRICALLY CONNECTED RADIATION PERFORMANCE, OF INVASIVE BLOOD
DETECTORS IEC 60601-2-23 MEDICAL ELECTRICAL EQUIPMENT – PART PRESSURE MONITORING EQUIPMENT
1-10: GENERAL REQUIREMENTS FOR BASIC
2-23: PARTICULAR REQUIREMENTS FOR THE
SAFETY AND ESSENTIAL PERFORMANCE -
IEC 60601-2-10 MEDICAL ELECTRICAL EQUIPMENT PART 2: SAFETY, INCLUDING ESSENTIAL IEC 60601-2-35 MEDICAL ELECTRICAL EQUIPMENT – PART
COLLATERAL STANDARD: REQUIREMENTS
PARTICULAR REQUIREMENTS FOR THE PERFORMANCE, OF 2: PARTICULAR REQUIREMENTS FOR THE
FOR THE DEVELOPMENT OF PHYSIOLOGIC
SAFETY OF NERVE AND MUSCLE TRANSCUTANEOUSPARTIAL PRESSURE SAFETY OF BLANKETS, PADS AND
CLOSED-LOOP CONTROLLERS
STIMULATORS MONITORING EQUIPMENT MATTRESSES, INTENDED FOR HEATING IN
IEC 60601-1-11 (ANW) MEDICAL ELECTRICAL EQUIPMENT - PART MEDICAL USE
IEC 60601-2-11 MEDICAL ELECTRICAL EQUIPMENT PART 2: IEC 60601-2-24 MEDICAL ELECTRICAL EQUIPMENT – PART
1-11: GENERAL REQUIREMENTS FOR BASIC
PARTICULAR REQUIREMENTS FOR THE 2-24: PARITCULAR REQUIREMENTS FOR THE IEC 60601-2-36 MEDICAL ELECTRICAL EQUIPMENT – PART
SAFETY AND ESSENTIAL PERFORMANCE -
SAFETY OF GAMMA BEAM THERAPY SAFETY OF INFUSION PUMPS AND 2: PARTICULAR REQUIREMENTS FOR THE
COLLATERAL STANDARD: REQUIREMENTS
EQUIPMENT CONTROLLERS SAFETY OF EQUIPMENT FOR
FOR MEDICAL ELECTRICAL EQUIPMENT AND
EXTRACORPOREALLY INDUCED LITHOTRIPSY
MEDICAL ELECTRICAL SYSTEM USED IN
HOME CARE APPLICATIONS

26 27
 Tried. Tested. Trusted.

IEC 60601-2-37 (CCDV) MEDICAL ELECTRICAL EQUIPMENT – PART IEC 60601-2-50 MEDICAL ELECTRICAL EQUIPMENT – PART APPENDIX E: PATIENT ENVIRONMENT
2-37: PARTICULAR REQUIREMENTS FOR THE 2-5O: PARTICULAR REQUIREMENTS FOR
BASIC SAFETY AND ESSENTIAL THE SAFETY OF INFANT PHOTOTHERAPY
PERFORMANCE OF ULTRASONIC MEDICAL EQUIPMENT
DIAGNOSTIC AND MONITORING EQUIPMENT
IEC 60601-2-51 MEDICAL ELECTRICAL EQUIPMENT – PART
IEC 60601-2-38 MEDICAL ELECTRICAL EQUIPMENT – PART 2-51: PARTICULAR REQUIREMENTS FOR
2: PARTICULAR REQUIREMENTS FOR THE SAFETY, INCLUDING ESSENTIAL
SAFETY OF ELECTRICALLY OPERATED PERFORMANCE, OF RECORDING AND
HOSPITAL BEDS ANALYSING SINGLE CHANNEL AND
MULTICHANNEL ELECTROCARDIOGRAPHS
IEC 60601-2-39 MEDICAL ELECTRICAL EQUIPMENT – PART
2-39: PARTICULAR REQUIREMENTS FOR THE IEC 60601-2-52 (ACDV) MEDICAL ELECTRICAL EQUIPMENT – PART
SAFETY OF PERITONEAL DIALYSIS 2-52: PARTICULAR REQUIREMENTS FOR 2.5m
EQUIPMENT BASIC SAFETY AND ESSENTIAL
PERFORMANCE OF MEDICAL BEDS
IEC 60601-2-40 MEDICAL ELECTRICAL EQUIPMENT – PART
2-40: PARTICULAR REQUIREMENTS FOR THE IEC 60601-2-53 (PWI) MEDICAL ELECTRICAL EQUIPMENT, PART 2-
SAFETY OF ELETROMYOGRAPHS AND 53: PARTICULAR REQUIREMENTS FOR THE
EVOKED RESPONSE EQUIPMENT SAFETY AND ESSENTIAL PERFORMANCE OF
A STANDARD COMMUNICATIONS
IEC 60601-2-41 MEDICAL ELECTRICAL EQUIPMENT – PART PROTOCOL FOR COMPUTER ASSISTED
2-41: PARTICULAR REQUIREMENTS FOR THE ELECTROCARDIOGRAPHY
SAFETY OF SURGICAL LUMINAIRES AND 1.5m 1.5m
LUMINAIRES FOR DIAGNOSIS IEC 60601-2-54 (ANW) MEDICAL ELECTRICAL EQUIPMENT – PART
2-54: PARTICULAR REQUIREMENTS FOR
IEC 60601-2-43 MEDICAL ELECTRICAL EQUIPMENT – PART BASIC SAFETY AND ESSENTIAL
2-43: PARTICULAR REQUIREMENTS FOR THE PERFORMANCE OF X-RAY EQUIPMENT FOR
SAFETY OF X-RAY EQUIPMENT FOR RADIOGRAPHY AND RADIOSCOPY
INTERVENTIONAL PROCEDURES
IEC 60601-2-56 (1CD) MEDICAL ELECTRICAL EQUIPMENT – PART
IEC 60601-2-44 MEDICAL ELECTRICAL EQUIPMENT – PART 2-56: PARTICULAR REQUIREMENTS FOR
2-44: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL
SAFETY OF X-RAY EQUIPMENT FOR PERFORMANCE OF SCREENING
COMPUTED TOMOGRAPHY

5m
THERMOGRAPHS FOR HUMAN FEBRILE

1.
TEMPERATURE SCREENING
IEC 60601-2-45 MEDICAL ELECTRICAL EQUIPMENT – PART
245: PARTICULAR REQUIREMENTS FOR THE IEC 60601-2-57 (ANW) PARTICULAR REQUIREMENTS FOR THE
SAFETY OF MAMMOGRAPHIC X-RAY SAFETY AND ESSENTIAL PERFORMANCE OF
EQUIPMENT AND MAMMOGRAPHIC INTENSE LIGHT SOURCES USED ON
STEREOTACTIC DEVICES HUMANS AND ANIMALS FOR MEDICAL AND
COSMETIC PURPOSES
IEC 60601-2-46 MEDICAL ELECTRICAL EQUIPMENT – PART
2-46: PARTICULAR REQUIREMENTS FOR THE IEC 60601-2-58 (ANW) MEDICAL ELECTRIC EQUIPMENT – PART 2-
SAFETY OF OPERATING TABLES 58 – PARTICULAR REQUIREMENTS FOR
BASIC SAFETY AND ESSENTIAL
IEC 60601-2-47 MEDICAL ELECTRICAL EQUIPMENT – PART PERFORMANCE OF LENS REMOVAL AND
2-47: PARTICULAR REQUIREMENTS FOR THE VITRECTOMY DEVICES FOR OPHTHALMIC
SAFETY, INCLUDING ESSENTIAL SURGERY
PERFORMANCE, OF AMBULATORY
ELECTROCARDIOGRAPHIC SYSTEMS
IEC 60601-2-49 MEDICAL ELECTRICAL EQUIPMENT – PART
2-49: PARTICULAR REQUIREMENTS FOR THE
SAFETY OF MULTIFUNCTION PATIENT
MONITORING EQUIPMENT Figure G1: Patient Environment

28 29
 Electrical simulators
SafetyTesters A new generation of simulators that offer flexibility,
Tried. Tested. Trusted.

Smart technology and an intimate knowledge of the job result in testers additional test functions and more accuracy.
designed for easier work and better results.

266 Plus 277 Plus 288 BP-Sim

NEW OXY-Sim
NEW 333
Electrical Safety Analyser Electrical Safety Analyser Electrical Safety Analyser NIBP Simulator SPO2 Simulator Patient Simulator

The Rigel 266 Plus is a highly The Rigel 277 Plus is a fully The 288 is the first truly The first hand-held NIBP The first hand-held SPO2 The 333 is one of the smallest,
compact, easy to use safety comprehensive electrical hand-held medical electrical simulator to incorporate simulator featuring pulse most powerful and fully
analyser designed to test in medical safety analyser used safety tester to combine the custom settings, including volume adjustments, heart rate comprehensive patient
accordance with IEC/EN 60601- within the widest possible features of an paediatric and adult NIBP and manufacturer-specific R- simulators available. Providing
1, MDA DB9801 and AS/NZ range of applications. The automatic/manual tester with a pressure simulations, pulse curves, combined with large a true 12 lead ECG signal with
3200. This compact unit ability to manage results and data logging/asset volume adjustments, heart rate capacity internal memory for 43 arrhythmias, dual invasive
provides highly effective and print records means that the management facility. Control is and manufacturer-specific the data capture, storage and blood pressure,
portable test user can manage the test and through a menu driven GUI. envelopes. Large capacity downloading via Bluetooth of respiration, temperature and
solutions. re-test procedure more Large data memory and internal memory for data test results for record keeping. industry standard waveforms.
productively. bluetooth facility make this an capture, storage and down-
effective, mobile unit. loading of test results via
Bluetooth.

Features include: Features include: Features include: Features include: Features include: Features include:
■ Small and compact ■ Conform IEC 60601 / 61010 / ■ Light, hand-held, battery operation ■ Light, hand-held, battery operation ■ Light, hand-held, battery operation ■ Light, hand-held, battery
■ Conform IEC 60601, MDA DB AAMI / NFPA-99 / AS-NZS 3200 ■ Conform IEC 62353 / 60601/ VDE ■ Adult & Paediatric NIBP ■ Tests probe and monitor both operation
9801 ■ Onboard printer & QWERTY 0751 / NFPA-99 / AS-NZS 3551 Simulations at the same time ■ Accurate 12-lead simulation of
■ 1-25A earthbond test current keyboard ■ Memory for up to 10,000 devices ■ Manufacturer specific O-curves ■ User configurable simulations 43 arrhythmia's
■ Upto 5 applied parts ■ 100mA to 25A earthbond current ■ Bluetooth communication ■ Overpressure and leak test ■ Manufacturer R-curves ■ Invasive blood pressure
■ Direct print facility ■ Full, semi automatic & manual tests ■ Full, semi automatic & manual ■ Memory for up to 10,000 devices ■ Memory for up to 10,000 devices ■ Temperature & respiration
■ Memory for up to 2,500 devices tests ■ Performance wave forms

30 31
 performance
analysers Tried. Tested. Trusted.

A new generation of analysers that offer flexibility, additional test

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NEW
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easy to use, large colour 12-lead ECG patient simulator ventilator parameters. Small, meters. Available with
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diathermy machine defibrillators, AED (Automatic rugged aluminium casing with
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Features include: Features include: Features include: Features include:

■ Power distribution from 10-5000Ω ■ Lightweight and compact ■ Hand-held & lightweight ■ Accurate
■ HF leakage test ■ Battery operation ■ Paediatric & adult ventilation ■ Battery powered
■ Remote plate security test ■ Mono & Biphasic waveforms ■ 8 parameters in single clear ■ Portable
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■ Internal memory ■ Direct print facility ■ Memory for up to 50 devices ■ Rugged design
■ Battery operated

32 33
 Accessories
Tried. Tested. Trusted.
Working with clients gives us valuable insights into what they need.

Med-eBase 601 Elite Bluetooth Scanner

Asset Management Software Calibration Checkbox Test n Tag Printer

Easily manage your test data to The 601 is a calibration A handy, hard-wearing printer, Portable Asset ID laser scanner
and from a range of Rigel verification instrument designed with impact-modified with build-in Bluetooth interface.
testers. Upload scheduled to accurately replicate the polycarbonate with fused oil and Compact and lightweight, the
safety tests for fast retesting of leakage characteristics of abrasion resistant rubber BT barcode scanner is ideal for
assets. Store all traceability data medical equipment. It offers overmould (six-foot drop those who want to quickly,
including: manufacturer name, both AC and DC leakage protection). Featuring smart accurately and consistently
model, serial number, asset currents and dedicated F-type battery management to monitor identify assets whilst being on-
description, site & location, circuitry. It provides calibrated the battery for longer life and the-move. Powered by standard
service code, user name, test values for earth and enclosure performance. Labels are LR-3 (AAA) batteries and
date, tester data and leakage, patient leakage and tamperproof, waterproof and compatible with all Bluetooth
comments. earthbond and insulation professionally printed with your enabled Rigel products.
references. logo and barcode.

Features include: Features include: Features include: Features include:

■ Download test data from Rigel ■ Simulates IEC/EN 60601 leakage ■ Portable and battery operation ■ Hand-held, battery powered
288, BP-Sim, OXY-Sim and ■ Pass & fail settings for B/BF ■ BlueTooth connectivity ■ Bluetooth connectivity
Rigel 377 & CF equipment ■ Low running cost ■ Compatible with all barcodes
■ Fast and easy schedule of retests ■ AC & DC leakage settings ■ Tamper proof, customised ■ Laser optics scanning
■ Upload retest data to Rigel 288 ■ Three earthbond test points barcode labels ■ Powered by LR-3 batteries
■ Stable SQL database structure ■ Two accurate insulation ■ Test result printing
■ Print and email certificates test points

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