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A Practical guideto IEc 62353


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Table of ContentsForeword 6

1. Introduction to IEC 62353 62. How does IEC 62353 compare with IEC 60601? 6

2.1. IEC 60601 72.2. In-Service Test Requirements 72.3. Technical Considerations 82.4. Preparation Vital 8

3. Commonly used definitions within IEC 60601 – IEC 62353 94. Symbols and Markings 105. Visual inspection 116. Earthbond Testing 11

6.1. Earthbond Test Consideration 127. Insulation Resistance Test 12

7.1. Insulation Resistance EUT to Earth 127.2. Insulation Resistance Applied Parts 137.3. Insulation Resistance Applied Parts to Mains 13

8. IEC 62353 Leakage Measurements 148.1. Method Characteristics 148.1.1. Direct Leakage Provides: 148.1.2. Differential method 158.1.3. Alternative method 168.2. IEC 601 Body Model 168.3. Equipment Leakage 178.3.1. Equipment Leakage Direct method 178.3.2. Equipment Leakage Differential method 188.3.3. Equipment Leakage Alternative method 198.4. Applied Part Leakage 208.4.1. Applied Part Leakage Direct method: 218.4.2. Applied Part Leakage Alternative method; 22

9. Record Keeping 2310. Conclusion 24

10.1. Considerations and Recommendations; 24Appendix A Pass/Fail limits of IEC 62353 25Appendix B IEC 60601-1 Measuring Device 25Appendix C IEC 60601-1 Collateral Standards 26Appendix D IEC 60601-2 Particular Standards 26Appendix E Patient environment 29Products in the Rigel Medical range 30

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Importantly, the new standard recognises thatthe laboratory conditions described in the IEC60601-1 cannot always be guaranteed when in-service testing of medical devices is undertaken.As a result, test measurements that requirecertain environmental conditions may not alwaysbe applicable or consistent for the testing ofequipment that is already in use. Another factorraised is that equipment could potentially bedamaged by applying type test specificationswhen in service and could therefore represent apotential danger to users.

2. HOW DOES IEC 62353 COMPARE WITH IEC 60601?

Although IEC 60601 is a type test standardgoverning the safety of the design andmanufacture of medical electrical equipment,most biomedical and clinical engineeringdepartments and medical service companies use

1. INTRODUCTION TO IEC 62353

As its full name implies, IEC 62353 MedicalElectrical Equipment – recurrent test and testafter repair of medical electrical equipment, isproposed to define the requirements of ensuringthe in-service electrical safety of electromedicalequipment and systems.

The IEC 62353 standard is an attempt toharmonise the various local standards andpractices to ensure safe operation and testing ofME Equipment and ME systems.

In meeting this requirement the IEC 62353incorporates tests beyond those of type testing.Specifically it seeks to provide a uniform andunambiguous means of assessing the safety ofmedical equipment, whilst maintaining therelation to IEC 60601-1 and minimising the risksto the person conducting the assessment.

FOREWORDThis booklet is written as a guideline for people involved in testing medical electrical equipmentand cannot be considered to replace the IEC 62353 standard.

Although all reasonable care has been taken to ensure accuracy of the information and referencefigures and data have been taken from the latest versions of various standards, guidance notesand recognised ‘best practices’ to establish the recommended testing requirements, RigelMedical, their agents and distributors, accept no responsibility for any error or omissions withinthis booklet, or for any misinterpretations by the user. For clarification on any part of this bookletplease contact Rigel Medical before operating any test instrument.

No part of this publication shall be deemed to form, or be part of any contract for training orequipment unless specifically referred to as an inclusion within such contract.

Rigel Medical assumes that the readers of this booklet are electronically technically competent andtherefore does not accept any liability arising from accidents or fatalities resulting directly orindirectly from the tests described in this booklet.

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it as the basis for regular testing of medicaldevices or after service or repair.

However this is likely to change with theintroduction of the proposed IEC 62353 which iscurrently being developed by the IEC tospecifically describe the test requirements for thein-service testing of medical devices.

So what will the implications of IEC 62353 beand how will it differ from the very wellestablished and widely understood requirementsof IEC 60601?

2.1. IEC 60601 Introduced by the International ElectrotechnicalCommittee to govern the design anddevelopment of medical equipment, theinternational safety standard IEC 60601 MedicalElectrical Equipment – General Requirements forSafety was first published in 1977 and becamewidely known in shorthand form as IEC 601.

Manufacturers of medical equipment arerequired to test to IEC 601 to ensure that thedesign of the equipment is intrinsically safe. Thestandard specifies the type testing requirementsfor protection against potential electric hazardsincluding protective Earthing (Earth continuity),Earth leakage currents, patient leakage currentand patient auxiliary currents.

As a type testing standard it describes a range ofmeasures that are intended to prove the safety ofan item of electromedical equipment during itsexpected useful life. These measures include acombination of stress and destructive tests thatmust be undertaken under certain environmentalconditions.

In many cases IEC 60601 has been translatedinto local national standards for use in certain

countries. Examples are EN 60601 (EC), ES60601, UL2601-1 (USA), CSA C22.2 (Canada)and AS/NZ 3200-1 (Australia/ New Zealand).

Clearly, safety testing at the design stage and atthe end of the production line is vitally important,but what about when the equipment entersservice? In the absence of a recognisedinternational standard for in-service testing, anumber of countries have already introducedtheir own national test recommendations.

For example, some countries have producedtheir own technical standards or guidelines forsafety testing of newly delivered medical devices(sometimes referred to as acceptance testing),others have specified the tests at regularintervals, (also referred to as preventivemaintenance) and some have testingrequirements directly following service or repair.Some examples are MDA DB9801 (UK), VDE750/751 (Germany), AS/NZ 3551 (Australia/NewZealand), NFPA-99 (USA).

In essence all these standards are linked by theaim to control the safety of medical devices usedthe treatment, care and diagnosis of patients andor individuals.

However, in those countries without any nationalguidance or code of practice on in-servicetesting, the convention has been to follow themanufacturer’s instructions which invariablyrequire that IEC 60601-1 test requirements andlimits be repeated.

2.2. IN-SERVICE TEST REQUIREMENTSAs a type testing electro-technical standard, thecurrent IEC 60601-1 does not provide anyguidance in harmonising test requirements oncean item of medical electrical equipment leavesthe production line.


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200mA instead of the required 25A in IEC 60601-1.

In terms of assessing leakage currents, IEC62353 incorporates a number of differentmeasurement methods to help guarantee saferpractice and the repeatability of measurements.

In addition to the direct leakage method as usedin IEC 60601-1, IEC 62353 also provides fordifferential leakage measurement (also referred toas residual current in some standards) and the‘alternative’ method. All these tests offer a varietyof advantages and disadvantages. (See 8.1 formore details).

2.4. PREPARATION VITALAlthough the new IEC 62353 standard and localadaptations are expected to be published in2007, all involved in the planning, managementand implementation of electrical safety testingprocedures for medical equipment should startto think about the possible implications now.

Although the onus will inevitably fall on themanufacturers of medical devices to advise onappropriate in-service test procedures for theirown equipment, the new standard will clearlyhave an impact on medical service companies,Biomed’s, medical physics, clinical engineeringand other technical departments.

To help all those likely to be affected by theintroduction of the new IEC 62353 standard, asummary of the test requirements is provided inthis IEC 62353 guidance booklet. This guidancebooklet is intended for general information onlyand is not intended for use as a replacement ofthe full version of the standard.

Once a medical device enters into service, anumber of potential test scenarios arise.

These are:

Acceptance Test also referred to as an Initial orReference Test. This test is carried out prior to anew medical device being authorised for use andis undertaken to ensure correct and completedelivery. Acceptance Testing is often not limitedto an electrical safety test, with some basicfunction tests being applied to verify correctperformance.

Routine Testing also referred to as PPM,Preventative Product Maintenance. This form oftesting is often conducted at fixed time intervals,which vary between types of equipment,manufacturer’s recommendations and riskassessment procedures undertaken by individualBME or medical physics departments. Routinetesting is not limited to safety testing and oftenincludes the verification of correct functionality.

After Service & Repair Testing is carried outfollowing a repair or product upgrade. It is oftenpart of a service carried out by in-hospitalmechanical or clinical engineering teams. Inmany cases, more rigorous electrical safetytesting is needed after the replacement ofcomponents or reconfiguration of medicaldevices.

2.3. TECHNICAL CONSIDERATIONSThe main aim of IEC 62353 is to provide a uniformstandard that ensures safe practice and reducesthe complexity of the current IEC 60601-1standard.

For example, one of the main differences will be inEarthbond testing, where the new standard willspecify a minimum Earthbond test current of

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3. COMMONLY USED DEFINITIONS WITHIN IEC 60601 – IEC 62353

Equipment Under TestThe equipment (EUT) which is the subject oftesting.

Device Under TestThe equipment (DUT) which is the subject oftesting.

Applied PartPart of the medical equipment which is designedto come into physical contact with the patient orparts that are likely to be brought into contactwith the patient.

Patient ConnectionIndividual physical connections and / or metalparts intended for connection with the patientwhich form (part of) an Applied Part.

Patient EnvironmentVolumetric area in which a patient can come intocontact with medical equipment or contact canoccur between other persons touching medicalequipment and the patient, both intentional andunintentional (see Appendix E).

F-Type Applied PartApplied Part which is electrically isolated fromEarth and other parts of the medical equipmenti.e. floating F-type Applied Parts are either typeBF or type CF Applied Parts.

Type B Applied PartApplied Part complying with specifiedrequirements for protection against electricshock. Type B Applied Parts are those parts,which are usually Earth referenced. Type B arethose parts not suitable for direct cardiacapplication.

Type BF Applied PartF-Type Applied Part complying with a higherdegree of protection against electric shock thantype B Applied Parts. Type BF Applied Parts arethose parts not suitable for direct cardiacapplication.

Type CF Applied PartF-Type Applied Part complying with the highestdegree of protection against electric shock. TypeCF Applied Parts are those parts suitable for directcardiac application.

Medical Electrical EquipmentElectrical equipment designed for treatment,monitoring or diagnoses of patients, poweredfrom not more than one connection to mainssupply and which are not necessarily in physicalor electrical contact with the patient or transfersenergy to or from the patient or detects suchenergy transfer to or from the patient.

Medical Electrical SystemCombination of equipment of which at least oneis classed as medical electrical equipment and isspecified by the manufacturer to be connectedby functional connection or use of a multipleportable socket-outlet.

Class IEquipment protection against electric shock by(Earthed) additional protection to basic insulationthrough means of connecting exposedconductive parts to the protective Earth in thefixed wiring of the installation.

Class IIAlso referred to as Double Insulated. Equipmentprotection against electric shock by additionalprotection to basic insulation through means ofsupplementary insulation are provided, therebeing no provision for the connection of exposed


metalwork of the equipment to a protectiveconductor and no reliance upon precautions tobe taken in the fixed wiring of the installation.

NOTE: CLASS II EQUIPMENT MAY BE PROVIDEDWITH A FUNCTIONAL EARTH TERMINAL OR AFUNCTIONAL EARTH CONDUCTOR.

4. SYMBOLS AND MARKINGS

The IEC 60601 has defined the requirements forinformation / data to be present on the medicalequipment’s nameplate, in order to form anunambiguous identification of the equipment. Information must include: Manufacturer’s name,model number, serial number, electricalrequirements etc.

The IEC 60601 standard refers to a large varietyof symbols for use on medical equipment,medical systems, accessories and other relatedparts. A full overview of the symbols used in IEC60601 is provided in the standard, table D1.

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For the purpose of this booklet, a selection of themost commonly used symbols is displayedbelow:

Class I

Class II

Earth Reference point

i.e. “Conformité Européenne”

Type B Applied Part

Defibrillation proof type B Applied Part

Type BF Applied Part

Defibrillation proof type BF Applied Part

Type CF Applied Part

Defibrillation proof type CF Applied Part

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5. VISUAL INSPECTION

The process of visual inspection is not clearlydefined by IEC 60601, however visualinspections form a critical part of the generalsafety inspections during the functional life ofmedical equipment. In most cases, 70% of allfaults are detected during visual inspection.Visual inspection is a relatively easy procedure tomake sure that the medical equipment in use stillconforms to the specifications as released by themanufacturer and has not suffered from anyexternal damage and/or contamination.

These can include the following inspections:

• Housing Enclosure – Look for damage, cracksetc

• Contamination – Look for obstruction ofmoving parts, connector pins etc

• Cabling (supply, Applied Parts etc) – Look forcuts, wrong connections etc

• Fuse rating – check correct values afterreplacement

• Markings and Labelling – check the integrityof safety markings

• Integrity of mechanical parts – check for anyobstructions

6. EARTHBOND TESTING

Earthbond Testing, also referred to asGroundbond Testing, tests the integrity of the lowresistance connection between the earthconductor and any metal conductive parts,which may become live in case of a fault onClass I medical devices.

Although many Class I medical devices aresupplied with an Earth reference point, most ifnot all medical devices require multipleEarthbond tests to validate the connections of

additional metal accessible parts on theenclosure.

The test current is applied between the Earth pinof the mains supply plug and any accessiblemetal part (including Earth reference point) via adedicated Earthbond test lead (clip/probe).Figure 1 shows a representation of theEarthbond test.

Figure 1: Earthbond test in Class I equipmentFor fixed installations a Point-to-Point continuitymeasurement can be made by fitting a secondlead into the Aux Earth socket. The resistance isthen measured between the two leads.

The IEC 62353 requires a minimum test currentof 200mA, either AC or DC. When using a DCtest current, the resistance must be tested inboth polarities of the test current. The highestreading will determine the PASS or FAIL result ofthis test.

The open circuit voltage of the current sourceshould not exceed 24V.

The Test limits in IEC 62353 are set to:

100mΩ for a detachable power cable up to 3metres


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300mΩ for a Class I device including powercable (not exceeding 3 metres)

500mΩ for a Medical System consisting ofseveral Medical and Non-Medicalpieces of Equipment. See definition ofMedical System in IEC 60601-1: 2005

6.1. EARTHBOND TEST CONSIDERATIONHigh Test Currents (10A or more) mightpotentially be destructive to parts of the DUTwhich are connected to the protective Earthbut have a functional purpose (e.g. screening).As such, consideration should be given to thetest current.

Low Test Currents (<8A) could potentiallyinfluence the reading as contact resistance isinfluenced by a number of factors (Constriction,Pressure, Film resistance). Higher Test Currentsovercome the contact resistance where lowercurrents show a relatively higher reading, thuspotentially causing unnecessary failures.

More on High vs Low Test Currents can beobtained in an application note on Earthbondtesting. Simply email [email protected] toreceive your free copy.

7. INSULATION RESISTANCE TEST

Unlike the standard IEC 60601-1 tests, the IEC62353 does provide a method of testing theInsulation of the Medical Device.The methods of testing insulation are separatedinto:• Insulation between Mains Parts and Earth (7.1)• Insulation between Applied Parts and Earth (7.2)• Insulation between Mains Parts and Earth (7.3)

7.1. INSULATION RESISTANCE EUT TOEARTHThis test is used to verify that the mains parts areadequately insulated from Earth (Class I) or theEnclosure (Class II). Figures 2A and 2B show arepresentation of the Insulation Test.

Figure 2A: Insulation EUT Test on Class I equipment

Figure 2B: Insulation EUT Test on Class II equipment

During this test, 500V D.C. is applied betweenthe Earth pin and both the Live and Neutralpins of the appliance mains supply plug.

For both Class I and Class II appliances plugthe DUT into the Safety Analyser. Class IIequipment requires an auxiliary lead to beconnected to the enclosure of the equipment.This can be done by wrapping the enclosurein aluminium foil and connecting to theauxiliary lead via an alligator clip.

Riso

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corresponding terminals of your safety analyser.For Class I equipment, plug the mains plug intothe safety analyser. Class II Equipment requiresan auxiliary lead to be connected to theenclosure of the equipment. This can be done bywrapping the enclosure in aluminium foil andconnecting to the auxiliary lead via an alligator clip.

7.3. INSULATION RESISTANCE APPLIEDPARTS TO MAINSThis test is used to verify that the Applied Partsare adequately insulated from the mains partsand is applicable to Class I and Class II BF andCF equipment only. Figure 4 show arepresentation of the Applied Parts to MainsInsulation test.

Figure 4: Insulation AP to Mains Test on Class I andClass II equipment

During this test, 500V D.C. is applied betweenall the Applied Parts combined and both thelive and neutral pins of the appliance mainssupply plug.

For both Class I and Class II appliances, connectthe Patient Connections or Applied Parts to thecorresponding terminals of your safety analyserand connect the mains plug into the safetyanalyser.

7.2. INSULATION RESISTANCE APPLIEDPARTSThis test is used to verify that the Applied Partsare adequately insulated from Earth (Class I) orthe Enclosure (Class II). This test is applicable toClass I and Class II, BF and CF equipment only.Figures 3A and 3B show a representation of thisInsulation test.

Figure 3A: Insulation AP Test on Class I equipment

Figure 3B: Insulation AP Test on Class I equipment

During this test, 500V D.C. is applied betweenthe Earth pin (Class I) or the Enclosure (ClassII) and all the Applied Parts combined.

For both Class I and Class II appliances, connectthe Patient Connections or Applied Parts to the


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set stringent rules on the design of medicalequipment so as to prevent any patient oroperator being exposed to currents not part ofthe functional operation of the device. Thesecurrents are referred to as leakage currents.

IEC 62353 defines two different kinds of LeakageCurrent Tests;

• Equipment Leakage Current – total leakagederiving from the Applied Parts, Enclosureand Mains Parts combined to real Earth

• Applied Part Leakage Current – totalleakage deriving from the combined PatientConnections within an Applied Part to Earthand any conductive or non conductive partson the enclosure

The IEC 62353 describes the following methodsto measure these Leakage Currents;

• Direct Leakage; Current flowing down theprotective Earth conductor of the mains inlet lead

• Differential Leakage; The result ofimbalance in current between the Liveconductor and the Neutral conductor

• Alternative Method; Current flowing througha person to earth from the Applied Part orcurrent flowing from a person to Earth via theApplied Part by applying unintended voltagefrom an external source

8.1. METHOD CHARACTERISTICS8.1.1. Direct Leakage Provides:The Direct Leakage Method is identical to themethod used in the IEC 60601-1 standard,measuring the true leakage through a bodymodel (Measuring Device) to Earth.

8. IEC 62353 LEAKAGE MEASUREMENTS

Research has shown that current not voltage isoften the source of injury or death. It takes only asmall amount of current to cause majorconsequences.

When an electrical current flows through thehuman body the effect is influenced by two mainfactors. Firstly the amount of current andsecondly the length of time the current flows.

For example, the heart stops if the currentpersists for:

a) 250mS at 40mAb) 100mS at 100mAc) 50mS at 200mA

Consider the following examples of the effect ofcurrent on the human body when applied to theskin (non invasive);

0.9–1.2mA Current just perceptible

15.0–20.0mA Release impossible: cannotbe tolerated over 15 minutes

50.0–100.0mA Ventricular fibrillation,respiratory arrest, leadingdirectly to death

100.0–200.0mA Serious burns and muscularcontraction of such a degreethat the thoracic musclesconstrict the heart

Compare these values to the fact that 250mA ofcurrent is required to power a 25 watt lamp.

For this reason, the IEC 60601 committee has

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Benefits• Means of measuring both AC and DC

leakage current

• Highest accuracy compared to othermethods

• Potential leakage through a human body viameasuring device

• Direct comparison with measurements madein accordance with IEC 60601-1

To consider• The 1kΩ resistor forming the Measuring

Device is interrupting the low resistanceProtective Earth Conductor, thus causing apotential hazard when testing faultyequipment

• Secondary Earth path(s). The EUT / DUTmust be positioned electrically isolated fromEarth during the measurement. A lowerleakage might be measured as not allleakage is measurable in the earth conductor

• Secondary connections are typical with:– Equipment bolted to steel enforced

concrete floor (e.g. dentist chairs, MRI)– Equipment connected to gas or water

supply– Equipment that is part of a Medical

Electrical System– Equipment connected to PC / Printer

• A difference in Polarity of the Live and Neutralconductors might alter the leakage readings,as such leakage measurements must bedone in each polar ity of mains supply

• A TN (Terre – Neutral) system is required to

ensure that the measurements are done atmaximum Live to Earth voltage. Any voltagebetween Neutral and Earth might result in alower reading, potentially passing faultyequipment

8.1.2. Differential methodThe Differential Leakage Method measures theleakage current as a result of an imbalance incurrent between the Live conductor and theNeutral conductor.

Potential secondary Earth connections areincluded in the total measurement and the EUTdoesn’t need to be positioned in isolation fromEarth.

Low leakage currents of less than 75μA aredifficult to measure using the Differential Leakagemethod. The Differential Leakage method isdeemed unsuitable for measuring conductiveUn-Earthed parts and in those instances whereleakages are expected to be below 75μA.

Benefits• The measurements are not influenced by

secondary Earth connections

• It measures the total equipment leakagecurrent

• The Measuring Device (1kΩ resistor) is nolonger in series with the Earth conductor,thus providing a low resistance ProtectiveEarth

To consider• The Differential Leakage measurement is less

suitable to accurately measure lower leakagecurrents (<100μA)


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• The measurements can be influenced byexternal magnetic fields or the analyser’s owninternal magnetic fields

• The measurements can be influenced by highcurrent consump tion of the DUT

• The measurements have limited frequencyresponse

• A difference in Polarity of the Live and Neutralconductors might alter the leakage readings.Leakage measurements must be done ineach polar ity of mains supply

• Both Direct and Alternative methods providehigher accuracy and broader frequencyresponse which is required for measuringtrends in low leakage conditions

8.1.3. Alternative methodThe Alternative Method is similar to a DielectricStrength Test at mains potential, using a currentlimited voltage source at mains frequency.

The Live and Neutral conductors are shortedtogether and the current limited voltage isapplied between the mains parts and other partsof the equipment.

Due to the current limiting resistor(s), the actualmeasuring voltage is dependent on the test load.The measured leakage current is scaled inproportion to the actual output voltage to predictthe actual leakage current flow at full mainspotential.

Benefits• As Live and Neutral are combined, the mains

polarity has no influence. Only onemeasurement is required

• The DUT is disconnected from the mains thusproviding a high level of safety for the testengineer

• TN-System is not required due to mains freeapplication

• Measurements are not influenced bysecondary earth connections

• Tests can be performed from a batterypowered instrument

• Measurements are highly repeatable andprovide a good indication of deterioration inthe dielectrics of the medical device under test

To consider• Equipment will not be activated thus

preventing the measurement of actual leakagecurrents on equipment with switched circuits

• The Alternative Method is not directlycomparable with the IEC 60601 test results

8.2. IEC 601 BODY MODELTo ensure a traceable simulation of current as ifpassing through a human body, measurementcircuits have been designed to simulate theaverage typical electrical characteristics of thehuman body. These measurement circuits arereferred to as Body Models or Measuring Device(MD in IEC 60601-1).

Some standards such as the NFPA-99 and theIEC 61010 (electrical equipment formeasurement, control and Laboratory use)specify different electrical characteristics to thatof the IEC 60601-1. The IEC 60601-1 Body Model or measuringdevice is shown in Appendix B.

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8.3. EQUIPMENT LEAKAGEThe Equipment Leakage Test measures the totalleakage deriving from the Applied Parts,Enclosure and Mains Parts combined to RealEarth. The Equipment Leakage Test is applicableto Class I and II, B, BF and CF equipment.

Leakage measurements to IEC 62353 are doneusing the RMS value instead of the separate ACand DC values used in the IEC 60601-1 standard.

The IEC 62353 specifies three different methodsof measuring the Equipment Leakage Current;

• Direct Method• Differential Method• Alternative Method

8.3.1. Equipment Leakage Direct method The Direct Method is identical to the methodused in the IEC 60601-1.

Figures 5A and 5B show a representation of theDirect Method.

Figure 5A: Equipment Leakage Direct - Class I

Figure 5B: Equipment Leakage Direct – Class II

The DUT must be positioned floating to avoidsecondary Earth connections influencing themeasuring process.

All Applied Parts (B, BF & CF) and Earthed (egenclosure Class I) and Non-Earthed accessibleconductive parts or non-conductive accessibleparts (enclosure Class II) are grouped togetherand connected to earth via the 1kΩ MeasuringDevice (Body Model).

The 1kΩ Measuring Device (MD – equivalent to thatused in the IEC 60601 standard – see Appendix B)is positioned in the leakage return path to Earth.

The test is conducted with the protective earthconnection interrupted to ensure themeasurements are done under worst conditions. Assuch, any Earth leakage current will be measured aspart of the enclosure (or touch) leakage.

Measurements are done in both polarities of theincoming mains with the protective Earth to theEUT interrupted.

Current in µA (RMS)APPLIED PART

B BF CF

Equipment leakage – direct or differential method

Class I Equipment 500μA 500μA 500μA

Class II Equipment (touch current) 100μA 100μA 100μA

L(N) MP AP

N(L)

MD

L(N) MP AP

N(L)

MD


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All Applied Parts (B / BF & CF) and Earthed(e.g. enclosure Class I) and Non-Earthedaccessible conductive parts or non-conductiveaccessible parts (enclosure Class II) are groupedtogether and connected to Earth to allow theDifferential circuit to measure the total leakagecurrent.

Unlike the Direct Method, the Differential methoddoes not measure via the standard IEC 60601Body Model in the Earth conductor. The MD ispart of a differential current measurementbetween the Live and Neutral conductors. Thefrequency response of the measurement issimilar to the Body Model used in the IEC 60601.

The test is conducted with the protective Earthconnection closed for protection of the user.

Measurements are done in both polarities of theincoming mains with the protective Earth to theEUT interrupted.

Low leakage currents of less than 75μA aredifficult to measure using the Differential Leakagemethod. The Differential Leakage method isunsuitable for measuring conductive Un-Earthedparts and in those instances where leakages areexpected to be below 75μA.

8.3.2. Equipment Leakage Differential methodFigures 6A and 6B show a representation of theDifferential Method.

Figure 6A: Equipment Leakage Differential – Class I

Figure 6B: Equipment Leakage Differential – Class IIPotential secondary Earth connections areincluded in the total measurement and the DUTis not required to be isolated from Earth.

L(N) MP

M

AP

N(L)

L(N) MP

M

AP

N(L)


B BF CF

Equipment leakage – direct or differential method



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The test is performed using current limited(3.5mA) mains potential sinusoidal 50Hz signal(60Hz where this is the mains frequency).

As Live and Neutral are shortened, the DUT isnot directly connected to the mains potential.Mains reversal is not applicable and the EUTdoes not need to be positioned isolated fromEarth.

All Applied Parts, Earthed (e.g. enclosure ClassI) and Non-Earthed accessible conductive partsor non-conductive accessible parts (enclosureClass II) are grouped together and connected tothe mains parts via the 1kΩ Measuring Device(Body Model) and voltage source.

The 1kΩ measuring Device (equivalent to thatused in the IEC 60601 standard – see AppendixB) is positioned directly after the voltage source.The test is conducted with the protective Earthconnection closed for protection of the user.

8.3.3. Equipment Leakage Alternative methodThis method is in fact similar to a dielectric testbetween the mains parts and all accessible parts(conductive and non-conductive) including theApplied Parts connected together. Figures 7Aand 7B show a representation of the AlternativeMethod.

Figure 7A: Equipment Leakage Alternative – Class I

Figure 7B: Equipment Leakage Alternative – Class II

MP AP

MD

MP AP

MD


B BF CF

Equipment leakage – alternative method




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8.4. APPLIED PART LEAKAGEThe Applied Part Leakage Test measures thetotal leakage deriving from the combined PatientConnections within an Applied Part to Earth andany conductive or non conductive parts on theenclosure (either connected or isolated fromEarth) under the fault condition Mains on AppliedParts.

The Applied Part Leakage Test is applicable toFloating type (BF & CF) Applied Parts onlyeither Class I or II.

All Patient Connections of a single function withinan Applied Part shall be connected together (BF& CF) and measured one at the time.

Applied Parts (and Patient Connections) not partof the measurement shall be left floating i.e. notconnected to real Earth.

The test is conducted by applying a currentlimited (3.5mA) mains potential sinusoidal 50Hzsignal (60Hz where this is the mains frequency)between the Applied Part and the Enclosure andEarth connection of the EUT connected to realEarth.

Leakage measurements to IEC 62353 are doneusing the RMS value instead of the separate ACand DC values used in the IEC 60601-1standard.

The IEC 62353/Applied Part Leakage can beperformed in two different methods; • Direct Method• Alternative Method

21

8.4.1. Applied Part Leakage Direct method: Figures 8A and 8B show a representation of theDirect Method.

Figure 8A: Applied Part Leakage Direct – Class I

Figure 8B: Applied Part Leakage Direct – Class II

The DUT must be positioned floating to avoidsecondary Earth connections influencing themeasuring process.

All floating type Patient Connections in eachApplied Part (BF & CF) are connected together.

Each Individual Applied Part is measured in turnand grouped with all Earthed (e.g. enclosure ClassI) and Non-Earthed accessible conductive parts ornon-conductive accessible parts (enclosure ClassII). These are grouped together and connected toEarth via the 1kΩ Measuring Device (Body Model).

Applied Parts and Patient Connections not part ofthe measurement shall be left floating.

The 1kΩMeasuring Device (MD - equivalent to thatused in the IEC 60601 standard – see Appendix B)is positioned between the Applied Part and VoltageSource.

The test is conducted with the protective Earthconnection closed for protection of the user. Measurements are done in both polarities of theincoming mains with the protective Earth to theEUT interrupted.

Warning: This Applied Part Direct Leakage test issimilar to that of the F-Type leakage test accordingto IEC 60601 using an equivalent current limitedvoltage source to produce the mains potential. Bothsources depend on a current limiting resistor whichcould cause a significant voltage drop.

Unlike the IEC 60601-1 requirements, the voltagedrop caused by the current limiting resistor iscompensated for in the IEC 62353 thus potentiallyresulting in a higher reading than the typical IEC60601-1 F-type test. Please refer to themanufacturers recommendations.

L(N) MP AP AP1

AP2N(L)

MD

L(N) MP AP AP1

AP2N(L)

MD


B BF CF

Patient leakage current – direct method (a.c.)

Class I & II 5000μA 50μA


22

As Live and Neutral are shortened, the DUT isnot directly connected to the mains potential.Therefore, mains reversal is not applicable andthe EUT does not need to be positioned inisolation from Earth.

All floating type Patient Connections in eachApplied Part (BF & CF) are connected together.Each Individual Applied Part is measured in turnand connected via the 1kΩ Measuring Device(Body Model) to the voltage source and Earthed(e.g. enclosure Class I) and Non-Earthedaccessible conductive parts or non-conductiveaccessible parts (enclosure Class II) groupedtogether.

Applied Parts and Patient Connections not partof the measurement shall be left floating. The 1kΩ Measuring Device (MD - equivalent tothat used in the IEC 60601 standard – seeAppendix B) is positioned between the AppliedPart and Voltage Source.

The test is conducted with the protective Earthconnection closed for the protection of the user.

8.4.2. Applied Part Leakage Alternative methodThis method is in fact similar to a dielectric testbetween the Applied Part and all mains parts,EUT Earth and Enclosure connected together.Figures 9A and 9B show a representation of theAlternative Method.

Figure 9A: Applied Part Leakage Alternative – Class I

Figure 9B: Applied Part Leakage Alternative – Class II

MP AP AP1

AP2

MD

MP AP AP1

AP2

MD


B BF CF

Patient leakage current – alternative method (a.c.)

Class I & II 5000μA 50μA

23

To ensure proper record keeping is maintained itis important to provide a procedure in which datais collected regarding:

• Inspection Date• Visual Inspection• Electrical Safety• Functional Testing• Next Inspection Date

The IEC 62353 provides a guideline in collectingsuch information with the purpose of developingconsistency in data collection and management.By doing so, trends can be monitored to benefit:

• Identifying common faults• Detect component deterioration (preventative

maintenance)• Develop efficient re-test periods

For the future, determining the appropriate levelsof both electrical and functional testing will becentral to the introduction of cost effective yetreliable preventative maintenance campaigns.

9. RECORD KEEPING

Overall, the area of risk assessment and thecreation of risk management files has become agrowing feature of routine safety testingdecisions, with different organisations anddepartments drawing-up individual plans to dealwith specific safety hazards. Comparison withprevious test results will therefore allow you tomonitor deterioration of the Device Under Testand prevent potential failure before a fault occurs.

Electrical safety testing is only part of the totalservice carried out on medical equipment. Oncethe safety has been proven, the functionality isverified and recorded before the equipment isreturned for use on patients.

This functional testing can be a combination ofsimulations and functional measurement such asmeasuring the output energy of defibrillators, theinfusion rate of infusion pumps and syringedrivers, the flow rate and frequency of ventilatorsand the energy output of surgical instruments.Patient monitors are designed to take a variety ofphysiological conditions to monitor the patient’svital signs. To ensure patient monitors aredisplaying the correct readings, a verification ofthe individual parameters is required.

Such verifications are typically done byspecialised equipment such as an OxygenSaturation Simulator (SPO2), Non-Invasive BloodPressure (NIBP) Simulator, TemperatureSimulator, ECG Simulator, Ventilator Tester,Infusion Pump Tester etc.


24

4. Ensure high accuracy and repeatability ofleakage measurement readings (somemanufacturers might specify full scaleaccuracy which will affect the accuracy of lowleakage measurements)

5. Ensure that contact resistance is taken intoaccount when measuring the Earth continuityat low currents (<8A). Contact resistance caninfluence the readings and causeunnecessary failures of the Device UnderTest. Ask for an application note on lowcurrent testing via [email protected](subject: low current testing)

6. When determining the correct means oftesting a specific item of Medical Equipment,ensure that the chosen safety testprocedures are applicable to the DeviceUnder Test and are clearly documented forfuture use

Rigel Medical offers a range of testequipment in line with IEC 62353 and IEC60601 requirements. Please visit our websitewww.rigelmedical.com for a full overview ofour product offering or register online for ourfree newsletter on future product releasesand product innovations.

For further questions or comments relating tothis booklet or the Rigel Medical productoffering, please contact John Backes [email protected]

10. CONCLUSION

Electrical safety testing of medical electronicdevices remains a crucial part of the overallsafety validation of medical devices and requiresspecialised test equipment.

The IEC 62353 standard will provide;

• Global test reference to allow uniform testing • Development tools for saver and suitable test

sequences• A method of record keeping and

maintenance procedures

When choosing your future electrical safetyanalyser, ensure that it can be used to test inaccordance with the IEC 62353 requirementsand secondly that your analyser will enable youto accurately and repeatedly produce the resultsyou require.

10.1 CONSIDERATIONS ANDRECOMMENDATIONS

1. Ensure that the operator of the safety testequipment is properly trained on both thesafety analyser and Device Under Test toprevent unneccessary danger during thesafety test

2. Always ensure that the Device Under Testdoes not pose any danger to the user and/orpeople within the vicinity to the safety test(e.g. moving parts, open conductors, Livecomponents, heat etc.)

3. Ensure that Leakage Measurements areperformed whilst the equipment is in fulloperation mode, including its sub-systems orcomponents

25

Z R2 C1

R1

V

+20

0

-20

-40

-60

10 102 103 104 105 106

Frequency (ƒ) in Hz

Rel

ativ

e m

agni

tud

ec) (d

b):

20 lo

gZ

(ƒ)

Z(ƒ

-10)

Voltagemeasuringinstrumentb)

R1 = 10k Ω ±5%a)

R2 = 1k Ω ±5%a)

C1 = 0.015 µF ±5%

APPENDIX A: PASS/FAIL LIMITS OF IEC 62353

NOTE 1: This IEC 62353 standard does not provide measuring methods and allowable values for equipment producing DC leakage currents. In such a case the manufacturer should give information in accompanying documents.

NOTE 2: Particular standards may allow different values of leakage current. For a list of particular standards, please refer to Appendix D.


B BF CFEquipment Leakage – alternative methodClass I Equipment 1000μA 1000μA 1000μAClass II Equipment 500μA 500μA 500μAEquipment leakage – direct or differential methodClass I Equipment 500μA 500μA 500μAClass II Equipment (touch current) 100μA 100μA 100μAPatient leakage current – alternative method (AC)Class I & II 5000μA 50μAPatient leakage current – direct method (AC) Class I & II 5000μA 50μA

APPENDIX B: IEC 60601-1 MEASURING DEVICE

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

a) Measuring Device b) Frequency Characteristics

Note: The network and voltage measuring instrument above is replaced by the symbol in thefollowing figures.

a) Non-inductive componentsb) Impedance >> measuring impedance Zc) Z(ƒ) is the transfer impedance of the network, i.e. Vout/in, for a current frequency ƒ.

MD


26

(© IEC Geneva, Switzerland)

IEC 60601-2-1 MEDICAL ELECTRICAL EQUIPMENT – PART2-1: PARTICULAR REQUIREMENTS FOR THESAFETY OF ELECTRON ACCELERATORS INTHE RANGE 1 MEV TO 50 MEV

IEC 60601-2-2 MEDICAL ELECTRICAL EQUIPMENT – PART2-2: PARTICULAR REQUIREMENTS FOR THESAFETY OF HIGH FREQUENCY SURGICALEQUIPMENT

IEC 60601-2-3 MEDICAL ELECTRICAL EQUIPMENT PART 2:PARTICULAR REQUIREMENTS FOR THESAFETY OF SHORT-WAVE THERAPYEQUIPMENT

IEC 60601-2-4 MEDICAL ELECTRICAL EQUIPMENT PART 2:PARTICULAR REQUIREMENTS FOR THESAFETY OF CARDIAC DEFIBRILLATORS ANDCARDIAC DEFIBRILLATORS MONITORS

IEC 60601-2-5 MEDICAL ELECTRICAL EQUIPMENT – PART2-5: PARTICULAR REQUIREMENTS FOR THESAFETY OF ULTRASONIC PHYSIOTHERAPYEQUIPMENT

IEC 60601-2-6 MEDICAL ELECTRICAL EQUIPMENT – PART2: PARTICULAR REQUIREMENTS FOR THESAFETY OF MICROWAVE THERAPYEQUIPMENT

IEC 60601-2-7 MEDICAL ELECTRICAL EQUIPMENT – PART2-7: PARTICULAR REQUIREMENTS FOR THESAFETY OF HIGH-VOLTAGE GENERATORS OFDIAGNOSTIC X-RAY GENERATORS

IEC 60601-2-8 MEDICAL ELECTRICAL EQUIPMENT – PART2-8: PARTICULAR REQUIREMENTS FOR THESAFETY OF THERAPEUTIC X-RAYEQUIPMENT OPERATING IN THE RANGE 10KV TO 1 MV

IEC 60601-2-9 MEDICAL ELECTRICAL EQUIPMENT – PART2: PARTICULAR REQUIREMENTS FOR THESAFETY OF PATIENT CONTACTDOSEMETERS USED IN RADIOTHERAPYWITHELECTRICALLY CONNECTED RADIATIONDETECTORS

IEC 60601-2-10 MEDICAL ELECTRICAL EQUIPMENT PART 2:PARTICULAR REQUIREMENTS FOR THESAFETY OF NERVE AND MUSCLESTIMULATORS

IEC 60601-2-11 MEDICAL ELECTRICAL EQUIPMENT PART 2:PARTICULAR REQUIREMENTS FOR THESAFETY OF GAMMA BEAM THERAPYEQUIPMENT

(© IEC Geneva, Switzerland)

IEC 60601-1-1 MEDICAL ELECTRICAL EQUIPMENT – PART1: GENERAL REQUIREMENTS FOR SAFETY 1:COLLATERAL STANDARD: SAFETYREQUIREMENTS FOR MEDICAL ELECTRICALSYSTEMS

IEC 60601-1-2 MEDICAL ELECTRICAL EQUIPMENT – PART1: GENERAL REQUIREMENTS FOR SAFETY 2.COLLATERAL STANDARD:ELECTROMAGNETIC COMPATIBILITY–REQUIREMENTS AND TESTS

IEC 60601-1-3 MEDICAL ELECTRICAL EQUIPMENT – PART1: GENERAL REQUIREMENTS FOR SAFETY –COLLATERAL STANDARD: GENERALREQUIREMENTS FOR RADIATIONPROTECTION IN DIAGNOSTIC X-RAYEQUIPMENT

IEC 60601-1-4 MEDICAL ELECTRICAL EQUIPMENT: PART 1-4: GENERAL REQUIREMENTS FORCOLLATERAL STANDARD: PROGRAMMABLEELECTRICAL MEDICAL SYSTEMS

IEC 60601-1-6 MEDICAL ELECTRICAL EQUIPMENT - PART1-6: GENERAL REQUIREMENTS FOR BASICSAFETY AND ESSENTIAL PERFORMANCE -COLLATERAL STANDARD: USABILITY

IEC 60601-1-8 MEDICAL ELECTRICAL EQUIPMENT - PART1-8: GENERAL REQUIREMENTS FOR BASICSAFETY AND ESSENTIAL PERFORMANCE -COLLATERAL STANDARD: GENERALREQUIREMENTS, TESTS AND GUIDANCE FORALARM SYSTEMS IN MEDICAL ELECTRICALEQUIPMENT AND MEDICAL ELECTRICALSYSTEMS

IEC 60601-1-9 (CDIS) MEDICAL ELECTRICAL EQUIPMENT - PART1-9: GENERAL REQUIREMENTS FOR BASICSAFETY AND ESSENTIAL PERFORMANCE -COLLATERAL STANDARD: REQUIREMENTSFOR ENVIRONMENTALLY CONSCIOUSDESIGN

IEC 60601-1-10 (ADIS) MEDICAL ELECTRICAL EQUIPMENT - PART1-10: GENERAL REQUIREMENTS FOR BASICSAFETY AND ESSENTIAL PERFORMANCE -COLLATERAL STANDARD: REQUIREMENTSFOR THE DEVELOPMENT OF PHYSIOLOGICCLOSED-LOOP CONTROLLERS

IEC 60601-1-11 (ANW) MEDICAL ELECTRICAL EQUIPMENT - PART1-11: GENERAL REQUIREMENTS FOR BASICSAFETY AND ESSENTIAL PERFORMANCE -COLLATERAL STANDARD: REQUIREMENTSFOR MEDICAL ELECTRICAL EQUIPMENT ANDMEDICAL ELECTRICAL SYSTEM USED INHOME CARE APPLICATIONS

APPENDIX C: IEC 60601-1 COLLATERAL STANDARDS APPENDIX D: IEC 60601-2 PARTICULAR STANDARDS

27

IEC 60601-2-25 MEDICAL ELECTRICAL EQUIPMENT – PART2-25: PARTICULAR REQUIREMENTS FOR THESAFETY OF ELECTROCARDIOGRAPHS

IEC 60601-2-26 MEDICAL ELECTRICAL EQUIPMENT PART 2:PARTICULAR REQUIREMENTS FOR THESAFETY OF ELECTROENCEPHALOGRAPHS

IEC 60601-2-27 MEDICAL ELECTRICAL EQUIPMENT – PART2: PARTICULAR REQUIREMENTS FOR THESAFETY OF ELECTROCARDIOGRAPHICMONITORING EQUIPMENT

IEC 60601-2-28 MEDICAL ELECTRICAL EQUIPMENT – PART2: PARTICULAR REQUIREMENTS FOR THESAFETY OF X-RAY SOURCE ASSEMBLIESAND X-RAY TUBE ASSEMBLIES FORMEDICAL DIAGNOSIS

IEC 60601-2-29 MEDICAL ELECTRICAL EQUIPMENT – PART2-29: PARTICULAR REQUIREMENTS FOR THESAFETY OF RADIOTHERAPY SIMULATORS

IEC 60601-2-30 MEDICAL ELECTRICAL EQUIPMENT – PART2-30: PARTICULAR REQUIREMENTS FOR THESAFETY, INCLUDING ESSENTIALPERFORMANCE, OF AUTOMATIC CYCLINGNON-INVASIVE BLOOD PRESSUREMONITORING EQUIPMENT

IEC 60601-2-31 MEDICAL ELECTRICAL EQUIPMENT – PART2: PARTICULAR REQUIREMENTS FOR THESAFETY OF EXTERNAL CARDIACPACEMAKERS WITH INTERNAL POWERSOURCE

IEC 60601-2-32 MEDICAL ELECTRICAL EQUIPMENT PART 2:PARTICULAR REQUIREMENTS FOR THESAFETY OF ASSOCIATED EQUIPMENT OF X-RAY EQUIPMENT

IEC 60601-2-33 MEDICAL ELECTRICAL EQUIPMENT – PART2: PARTICULAR REQUIREMENTS FOR THESAFETY OF MAGNETIC RESONANCEEQUIPMENT FOR MEDICAL DIAGNOSIS

IEC 60601-2-34 MEDICAL ELECTRICAL EQUIPMENT – PART2: PARTICULAR REQUIREMENTS FOR THESAFETY, INCLUDING ESSENTIALPERFORMANCE, OF INVASIVE BLOODPRESSURE MONITORING EQUIPMENT

IEC 60601-2-35 MEDICAL ELECTRICAL EQUIPMENT – PART2: PARTICULAR REQUIREMENTS FOR THESAFETY OF BLANKETS, PADS ANDMATTRESSES, INTENDED FOR HEATING INMEDICAL USE

IEC 60601-2-36 MEDICAL ELECTRICAL EQUIPMENT – PART2: PARTICULAR REQUIREMENTS FOR THESAFETY OF EQUIPMENT FOREXTRACORPOREALLY INDUCED LITHOTRIPSY

IEC 60601-2-12 MEDICAL ELECTRICAL EQUIPMENT – PART2: PARTICULAR REQUIREMENTS FOR THESAFETY OF LUNG VENTILATORS FORMEDICAL USE

IEC 60601-2-13 MEDICAL ELECTRICAL EQUIPMENT – PART2-13: PARTICULAR REQUIREMENTS FOR THESAFETY OF ANAESTHETIC WORKSTATIONS

IEC 60601-2-14 MEDICAL ELECTRICAL EQUIPMENT – PART2: PARTICULAR REQUIREMENTS FOR THESAFETY OF ELECTROCONVULSIVE THERAPYEQUIPMENT

IEC 60601-2-15 MEDICAL ELECTRICAL EQUIPMENT – PART2: PARTICULAR REQUIREMENTS FOR THESAFETY OF CAPACITOR DISCHARGE X-RAYGENERATORS

IEC 60601-2-16 MEDICAL ELECTRICAL EQUIPMENT – PART2: PARTICULAR REQUIREMENTS FOR THESAFETY OF HAEMODIALYSIS EQUIPMENT

IEC 60601-2-17 MEDICAL ELECTRICAL EQUIPMENT – PART2: PARTICULAR REQUIREMENTS FOR THESAFETY OF REMOTE-CONTROLLEDAUTOMATICALLY DRIVEN GAMMARAYAFTER-LOADING EQUIPMENT

IEC 60601-2-18 MEDICAL ELECTRICAL EQUIPMENT PART 2:PARTICULAR REQUIREMENTS FOR THESAFETY OF ENDOSCOPIC EQUIPMENT

IEC 60601-2-19 MEDICAL ELECTRICAL EQUIPMENT – PART2: PARTICULAR REQUIREMENTS OF SAFETYOF BABY INCUBATORS

IEC 60601-2-20 MEDICAL ELECTRICAL EQUIPMENT – PART2: PARTICULAR REQUIREMENTS FOR THESAFETY OF TRANSPORT INCUBATORS

IEC 60601-2-21 MEDICAL ELECTRICAL EQUIPMENT PART 2:PARTICULAR REQUIREMENTS FOR THESAFETY OF INFANT RADIANT WARMERS

IEC 60601-2-22 MEDICAL ELECTRICAL EQUIPMENT – PART2: PARTICULAR REQUIREMENTS FOR THESAFETY OF DIAGNOSTIC AND THERAPEUTICLASER EQUIPMENT

IEC 60601-2-23 MEDICAL ELECTRICAL EQUIPMENT – PART2-23: PARTICULAR REQUIREMENTS FOR THESAFETY, INCLUDING ESSENTIALPERFORMANCE, OFTRANSCUTANEOUSPARTIAL PRESSUREMONITORING EQUIPMENT

IEC 60601-2-24 MEDICAL ELECTRICAL EQUIPMENT – PART2-24: PARITCULAR REQUIREMENTS FOR THESAFETY OF INFUSION PUMPS ANDCONTROLLERS


28

IEC 60601-2-37 (CCDV) MEDICAL ELECTRICAL EQUIPMENT – PART2-37: PARTICULAR REQUIREMENTS FOR THEBASIC SAFETY AND ESSENTIALPERFORMANCE OF ULTRASONIC MEDICALDIAGNOSTIC AND MONITORING EQUIPMENT

IEC 60601-2-38 MEDICAL ELECTRICAL EQUIPMENT – PART2: PARTICULAR REQUIREMENTS FOR THESAFETY OF ELECTRICALLY OPERATEDHOSPITAL BEDS

IEC 60601-2-39 MEDICAL ELECTRICAL EQUIPMENT – PART2-39: PARTICULAR REQUIREMENTS FOR THESAFETY OF PERITONEAL DIALYSISEQUIPMENT

IEC 60601-2-40 MEDICAL ELECTRICAL EQUIPMENT – PART2-40: PARTICULAR REQUIREMENTS FOR THESAFETY OF ELETROMYOGRAPHS ANDEVOKED RESPONSE EQUIPMENT

IEC 60601-2-41 MEDICAL ELECTRICAL EQUIPMENT – PART2-41: PARTICULAR REQUIREMENTS FOR THESAFETY OF SURGICAL LUMINAIRES ANDLUMINAIRES FOR DIAGNOSIS

IEC 60601-2-43 MEDICAL ELECTRICAL EQUIPMENT – PART2-43: PARTICULAR REQUIREMENTS FOR THESAFETY OF X-RAY EQUIPMENT FORINTERVENTIONAL PROCEDURES

IEC 60601-2-44 MEDICAL ELECTRICAL EQUIPMENT – PART2-44: PARTICULAR REQUIREMENTS FOR THESAFETY OF X-RAY EQUIPMENT FORCOMPUTED TOMOGRAPHY

IEC 60601-2-45 MEDICAL ELECTRICAL EQUIPMENT – PART245: PARTICULAR REQUIREMENTS FOR THESAFETY OF MAMMOGRAPHIC X-RAYEQUIPMENT AND MAMMOGRAPHICSTEREOTACTIC DEVICES

IEC 60601-2-46 MEDICAL ELECTRICAL EQUIPMENT – PART2-46: PARTICULAR REQUIREMENTS FOR THESAFETY OF OPERATING TABLES

IEC 60601-2-47 MEDICAL ELECTRICAL EQUIPMENT – PART2-47: PARTICULAR REQUIREMENTS FOR THESAFETY, INCLUDING ESSENTIALPERFORMANCE, OF AMBULATORYELECTROCARDIOGRAPHIC SYSTEMS

IEC 60601-2-49 MEDICAL ELECTRICAL EQUIPMENT – PART2-49: PARTICULAR REQUIREMENTS FOR THESAFETY OF MULTIFUNCTION PATIENTMONITORING EQUIPMENT

IEC 60601-2-50 MEDICAL ELECTRICAL EQUIPMENT – PART2-5O: PARTICULAR REQUIREMENTS FORTHE SAFETY OF INFANT PHOTOTHERAPYEQUIPMENT

IEC 60601-2-51 MEDICAL ELECTRICAL EQUIPMENT – PART2-51: PARTICULAR REQUIREMENTS FORSAFETY, INCLUDING ESSENTIALPERFORMANCE, OF RECORDING ANDANALYSING SINGLE CHANNEL ANDMULTICHANNEL ELECTROCARDIOGRAPHS

IEC 60601-2-52 (ACDV) MEDICAL ELECTRICAL EQUIPMENT – PART2-52: PARTICULAR REQUIREMENTS FORBASIC SAFETY AND ESSENTIALPERFORMANCE OF MEDICAL BEDS

IEC 60601-2-53 (PWI) MEDICAL ELECTRICAL EQUIPMENT, PART 2-53: PARTICULAR REQUIREMENTS FOR THESAFETY AND ESSENTIAL PERFORMANCE OFA STANDARD COMMUNICATIONSPROTOCOL FOR COMPUTER ASSISTEDELECTROCARDIOGRAPHY

IEC 60601-2-54 (ANW) MEDICAL ELECTRICAL EQUIPMENT – PART2-54: PARTICULAR REQUIREMENTS FORBASIC SAFETY AND ESSENTIALPERFORMANCE OF X-RAY EQUIPMENT FORRADIOGRAPHY AND RADIOSCOPY

IEC 60601-2-56 (1CD) MEDICAL ELECTRICAL EQUIPMENT – PART2-56: PARTICULAR REQUIREMENTS FORBASIC SAFETY AND ESSENTIALPERFORMANCE OF SCREENINGTHERMOGRAPHS FOR HUMAN FEBRILETEMPERATURE SCREENING

IEC 60601-2-57 (ANW) PARTICULAR REQUIREMENTS FOR THESAFETY AND ESSENTIAL PERFORMANCE OFINTENSE LIGHT SOURCES USED ONHUMANS AND ANIMALS FOR MEDICAL ANDCOSMETIC PURPOSES

IEC 60601-2-58 (ANW) MEDICAL ELECTRIC EQUIPMENT – PART 2-58 – PARTICULAR REQUIREMENTS FORBASIC SAFETY AND ESSENTIALPERFORMANCE OF LENS REMOVAL ANDVITRECTOMY DEVICES FOR OPHTHALMICSURGERY

29

1.5m 1.5m

1.5m

2.5m

Figure G1: Patient Environment

APPENDIX E: PATIENT ENVIRONMENT


30

288Electrical Safety Analyser

The 288 is the first trulyhand-held medical electricalsafety tester to combine thefeatures of anautomatic/manual tester with adata logging/assetmanagement facility. Control isthrough a menu driven GUI.Large data memory andbluetooth facility make this aneffective, mobile unit.

Features include:■ Light, hand-held, battery operation■ Conform IEC 62353 / 60601/ VDE

0751 / NFPA-99 / AS-NZS 3551■ Memory for up to 10,000 devices■ Bluetooth communication■ Full, semi automatic & manual

tests

277 PlusElectrical Safety Analyser

The Rigel 277 Plus is a fullycomprehensive electricalmedical safety analyser usedwithin the widest possiblerange of applications. Theability to manage results andprint records means that theuser can manage the test andre-test procedure moreproductively.

Features include:■ Conform IEC 60601 / 61010 /

AAMI / NFPA-99 / AS-NZS 3200■ Onboard printer & QWERTY

keyboard■ 100mA to 25A earthbond current■ Full, semi automatic & manual tests■ Memory for up to 2,500 devices

266 PlusElectrical Safety Analyser

The Rigel 266 Plus is a highlycompact, easy to use safetyanalyser designed to test inaccordance with IEC/EN 60601-1, MDA DB9801 and AS/NZ3200. This compact unitprovides highly effective andportable testsolutions.

Features include:■ Small and compact■ Conform IEC 60601, MDA DB9801■ 1-25A earthbond test current■ Upto 5 applied parts■ Direct print facility

ElectricalSafetyTestersSmart technology and an intimate knowledge of the job result in testers designed for easier work and better results.

31

333Patient Simulator

The 333 is one of the smallest,most powerful and fullycomprehensive patientsimulators available. Providinga true 12 lead ECG signal with43 arrhythmias, dual invasiveblood pressure,respiration, temperature andindustry standard waveforms.

Features include:■ Light, hand-held, battery

operation ■ Accurate 12-lead simulation of

43 arrhythmia's■ Invasive blood pressure■ Temperature & respiration■ Performance wave forms

OXY-SimSPO2 Simulator

The first hand-held SPO2

simulator featuring pulsevolume adjustments, heart rateand manufacturer-specific R-curves, combined with largecapacity internal memory forthe data capture, storage and downloading via Bluetooth of test results for record keeping.

Features include:■ Light, hand-held, battery operation■ Tests probe and monitor both

at the same time■ User configurable simulations■ Manufacturer R-curves■ Memory for up to 10,000 devices

BP-SimNIBP Simulator

The first hand-held NIBPsimulator to incorporatecustom settings, includingpaediatric and adult NIBPpressure simulations, pulsevolume adjustments, heart rateand manufacturer-specificenvelopes. Large capacityinternal memory for datacapture, storage and down-loading of test results viaBluetooth.

Features include:■ Light, hand-held, battery operation■ Adult & Paediatric NIBP

Simulations■ Manufacturer specific O-curves■ Overpressure and leak test■ Memory for up to 10,000 devices


NEW NEW

simulatorsA new generation of simulators that offer flexibility, additional test functions and more accuracy.

32

NEW355Ventilator Tester

The 355 is a highly accurateportable ventilator tester, withquick and easy testing ofventilator parameters. Small,tough and able to store a largeamount of real-time ventilatorcharacteristics.

Features include:■ Hand-held & lightweight ■ Paediatric & adult ventilation ■ 8 parameters in single clear

display ■ Memory for up to 50 devices■ Battery operated

344Defibrillator Analyser

Combining the functions of adefibrillator tester, an externalpacemaker analyser, and a12-lead ECG patient simulatorinto a compact, lightweight,easy to use instrument. Tests mono and bi-phasicdefibrillators, AED (AutomaticElectronic Defibrillator) and allexternal transcutaneous andtransvenous pacemakers.

Features include:■ Lightweight and compact ■ Battery operation ■ Mono & Biphasic waveforms ■ Full 12-lead patient simulator ■ Direct print facility

377Electrosurgical Analyser

The 377 offers the latesttechnology in high frequencypower measurement. Small,easy to use, large colourdisplay and innovativenavigation make this a fast,efficient test tool for testingdiathermy machineperformance. Large internalmemory and PCcommunication for traceabilityof the test data.

Features include:■ Power distribution from 10-5000Ω■ HF leakage test■ Remote plate security test■ Colour graphic power test results■ Internal memory

performanceanalysersA new generation of analysers that offer flexibility, additional testfuctions and more accuracy.

33


400 SeriesPressure Meters

The 400 series are a versatilerange of high performancedigital-pressure vacuummeters. Available withaccuracies from 0.1% to0.05% as well as variouspressure ranges. Housed in arugged aluminium casing withsealed membrane keypadsand available with an optionaldata output connector.

Features include:■ Accurate■ Battery powered■ Portable■ Vacuum and pressure■ Rugged design

34

EliteTest n Tag Printer

A handy, hard-wearing printer,with impact-modifiedpolycarbonate with fused oil andabrasion resistant rubberovermould (six-foot dropprotection). Featuring smartbattery management to monitorthe battery for longer life andperformance. Labels aretamperproof, waterproof andprofessionally printed with yourlogo and barcode.

Features include:■ Portable and battery operation■ BlueTooth connectivity■ Low running cost■ Tamper proof, customised

barcode labels■ Test result printing

601Calibration Checkbox

The 601 is a calibrationverification instrument designedto accurately replicate theleakage characteristics ofmedical equipment. It offersboth AC and DC leakagecurrents and dedicated F-typecircuitry. It provides calibratedvalues for earth and enclosureleakage, patient leakage andearthbond and insulationreferences.

Features include:■ Simulates IEC/EN 60601 leakage■ Pass & fail settings for B/BF

& CF equipment■ AC & DC leakage settings■ Three earthbond test points■ Two accurate insulation

test points

Med-eBaseAsset Management Software

Easily manage your test data toand from a range of Rigeltesters. Upload scheduledsafety tests for fast retesting ofassets. Store all traceability dataincluding: manufacturer name,model, serial number, assetdescription, site & location,service code, user name, testdate, tester data andcomments.

Features include:■ Download test data from Rigel

288, BP-Sim, OXY-Sim and Rigel 377

■ Fast and easy schedule of retests ■ Upload retest data to Rigel 288 ■ Stable SQL database structure ■ Print and email certificates

AccessoriesWorking with clients gives us valuable insights into what they need.

35


Bluetooth Scanner

Portable Asset ID laser scannerwith build-in Bluetooth interface.Compact and lightweight, theBT barcode scanner is ideal forthose who want to quickly,accurately and consistentlyidentify assets whilst being on-the-move. Powered by standardLR-3 (AAA) batteries andcompatible with all Bluetoothenabled Rigel products.

Features include:■ Hand-held, battery powered■ Bluetooth connectivity■ Compatible with all barcodes■ Laser optics scanning■ Powered by LR-3 batteries

Rigel Medical, Bracken Hill, South West Industrial Estate,Peterlee, County Durham, SR8 2SW United Kingdom

Tel: +44 (0) 191 587 8730 Fax: +44 (0) 191 586 0227Email: [email protected] Web: www.rigelmedical.com

Seaward, Clare, Rigel Medical,Cropico, Seaward Group USA

are all part of the Seaward Group

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