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Seaward Rigel 288+ Practical Manual

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A Practical Guide to IEC 62353
rigelmedical.com

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  • Page 1 A Practical Guide to IEC 62353 rigelmedical.com...

  • Page 2: Table Of Contents

    Appendix C: IEC 60601 prior written consent from Seaward Electronic Ltd. This also applies to accompanying drawings and diagrams. test standards PG 2...

  • Page 3: Foreword

    A PRACTICAL GUIDE TO IEC 62353 Rigel Medical: Foreword Keeping This booklet is written as a guideline for people involved in testing medical electrical medical (ME) equipment. This booklet cannot be considered as a industries safe replacement for the IEC 62353 publication, which can be purchased through the official IEC website, http://webstore.iec.ch/.

  • Page 4: Introduction

    RIGEL MEDICAL Introduction There is a directly proportional relationship between the electrical current (ampere) through and the electrical potential (volt) This guide covers a basic introduction to across the conductor (ohm). This is commonly electrical safety, definitions of a medical known as Ohm’s law: electronic device, the IEC 60601 standard and an in depth overview of the IEC 62353...
  • Page 5 A PRACTICAL GUIDE TO IEC 62353 ∙ The thinner or longer the water pipe, the more water pressure is required to deliver the same litres per minute (flow or current) ∙ The thinner or longer the conductor (assuming a particular specific resistance of material), the more voltage is required to deliver the same current.
  • Page 6 RIGEL MEDICAL blood circulation, and move into ventricular fibrillation. This stops the circulation of oxyhaemoglobin (oxygenated blood) to the brain and organs and when left untreated, will result in death within 15 minutes. Ironically, the most common treatment of ventricular fibrillation is the use of a defibrillator which delivers a very high current pulse, up to 100A across the heart.

  • Page 7: Medical Electronic Equipment

    A PRACTICAL GUIDE TO IEC 62353 Note: The network and voltage measuring instrument above are replaced by the symbol in the following figures: a) Non-inductive components b) Impedance >> measuring impedance Z c) Z ( f ) is the transfer impedance of the network, i.e. V , for a current frequency f out/in Figure 4 - Example of a measuring device (MD) to IEC 60601...

  • Page 8: Equipment

    RIGEL MEDICAL F-Type applied part - Applied part which is medical electronic system. To ensure safety of patient and operator, this system must meet electrically isolated from earth and other parts the design requirements of IEC 60601. of the medical equipment, i.e. floating. F-Type applied parts are either type BF or type CF The definition of a medical electronic system is: applied parts.
  • Page 9 A PRACTICAL GUIDE TO IEC 62353 Protective earth - Dedicated circuit intended medical systems, accessories and other related to carry the fault and leakage current in Class parts. A full overview of the symbols used in IEC I equipment and to be connected to the 60601 is provided in table D1 of the standard.
  • Page 10 RIGEL MEDICAL Acceptance there’s no risk of harm to the patient and operator once the device goes into service. Once a medical device reaches the client, an acceptance test is performed. This test is to verify that the device is delivered in an acceptable condition, complete without DESIGN (IEC 60601)

  • Page 11: Iec 60601

    A PRACTICAL GUIDE TO IEC 62353 IEC 60601 the power supply to the enclosure (MOOP) or protective earth wire (MOOP and MOPP) or even to the patient connected parts (MOPP). ME equipment must meet the design requirements as set out by the IEC 60601 In IEC 60601, the test requirements for (a harmonised standard), which has been electrical leakage must be carried out under...

  • Page 12: Introduction To Iec 62353: 2014

    RIGEL MEDICAL After service and repair testing this is carried manufacturing and marketing, a subset of tests will suffice to ensure the product has been out following a repair or product upgrade built and assembled to the required product and is often part of a service carried out by quality and safety requirements.
  • Page 13 A PRACTICAL GUIDE TO IEC 62353 risks to the person conducting the assessment. pass/fail limits, taken from internationally accepted practices for insulation testing of Importantly, the IEC 62353 standard recognises electrical equipment. While insulation tests that the laboratory conditions described are optional, it’s recommended to check with in the IEC 60601, such as elevated mains, the equipment manufacturer if this can be...
  • Page 14 RIGEL MEDICAL Technical considerations requirements of IEC 60601? The aim of IEC 62353 is to provide a uniform Test frequency standard that ensures safe practices and To ensure safety and performance is managed reduces the complexity of the current IEC throughout the lifecycle of medical electrical 60601-1 standard.

  • Page 15: Visual Inspection

    A PRACTICAL GUIDE TO IEC 62353 Vital preparation A visual inspection is a relatively easy Although IEC 62353 was first published in procedure, which is carried out to ensure that May 2007, many companies and organisations the ME equipment in use still conforms to the are still in the process of making changes to specifications released by the manufacturer their approach to electrical safety testing.
  • Page 16 RIGEL MEDICAL Although many Class I medical devices are The open circuit voltage of the current source supplied with an earth reference point, most should not exceed 24V. if not all medical devices require multiple The test limits in IEC 62353 are set to: earth bond tests to validate the connections of additional metal accessible parts on the enclosure.
  • Page 17 A PRACTICAL GUIDE TO IEC 62353 Low pressure applied Increased pressure (High resistance) (Low resistance) Figure 8 - Example of increased contact resistance in spring loaded contacts the protective earth path. Lower test currents, typically less than 8A RMS, are unable to temporarily overcome Precision vs accuracy contact resistance (both film and restriction When performing an earth bond test,...

  • Page 18: Insulation Resistance Test

    RIGEL MEDICAL Low test current with high current pre-test (see Figure 11 ) - Cleans film resistance, any high readings would be down to poor contact resistance, therefore high accuracy and high precision. Figure 9 - Low accuracy - low precision Figure 10 - Low accuracy - high precision Figure 11 - High accuracy - high precision Insulation resistance test...
  • Page 19 A PRACTICAL GUIDE TO IEC 62353 ∙ Input (phase and neutral) and output not provide a real indication of the effectiveness (applied parts) for floating type applied of the insulation in modern medical devices parts (BF and CF). (See Insulation resistance: or the expected leakage values that may be applied parts to mains ).
  • Page 20 RIGEL MEDICAL or the enclosure (Class II). Figure 12 and Insulation resistance: applied parts Figure 13 below show a representation of the This test is used to verify that the applied parts insulation test. are adequately insulated from earth (Class I) or the enclosure (Class II).
  • Page 21 A PRACTICAL GUIDE TO IEC 62353 For both Class I and Class II appliances, connect the patient connections or applied parts to the corresponding terminals of your safety analyser. For Class I equipment, plug the mains plug into the safety analyser. Class II equipment BF,CF requires an auxiliary lead to be connected to the enclosure of the equipment.

  • Page 22: Iec 62353 Leakage Measurements

    RIGEL MEDICAL IEC 62353 leakage the live and neutral wire (see Alternative method) measurements Direct leakage As covered in The human body , it is the level The direct leakage method is identical to the of electrical current rather than level of voltage method used in the IEC 60601-1 standard;...

  • Page 23: Measurements

    A PRACTICAL GUIDE TO IEC 62353 Differential method current. The differential leakage method measures the Potential secondary earth connections are leakage current as a result of an imbalance in included in the total measurement and as current between the live conductor and the such, the EUT is not required to be isolated neutral conductor.

  • Page 24: Measurements

    RIGEL MEDICAL = 66k ∙ Both direct and alternative methods provide higher accuracy and broader frequency response which is required for measuring trends in low leakage U=230V ±2.2mA 50HZ conditions Alternative method The alternative method is, in effect, similar to a dielectric strength test at mains potential, or Figure 18 - Example of current limited mains supply during alternative leakage...

  • Page 25: Measurements

    A PRACTICAL GUIDE TO IEC 62353 ∙ Tests can be performed from a battery L(N) powered instrument ∙ Measurements are highly repeatable and N(L) provide a good indication of deterioration in the dielectrics of the medical device under test To consider: ∙...

  • Page 26: Measurements

    RIGEL MEDICAL measurements are carried out under the worst possible conditions. As such, any earth leakage current will be measured as part of the enclosure (or touch) leakage. Measurements are done in both polarities of the incoming mains with the protective earth to the EUT interrupted.

  • Page 27: Measurements

    A PRACTICAL GUIDE TO IEC 62353 Unlike the direct method, the differential Measurements are done in both polarities of method does not measure the earth the incoming mains with the protective earth conductor via the standard IEC 60601 body to the EUT interrupted. model.

  • Page 28: Measurements

    RIGEL MEDICAL The test is performed using a current limited All applied parts, and earthed (e.g. enclosure (3.5mA) mains potential sinusoidal 50Hz signal Class I) and non-earthed accessible conductive (60Hz where this is the mains frequency). parts or non-conductive accessible parts (enclosure Class II) are grouped together and As live and neutral are shortened, the DUT is connected to the mains parts via the 1kΩ...

  • Page 29: Measurements

    A PRACTICAL GUIDE TO IEC 62353 Applied part leakage: Direct method Applied parts and patient connections not part Figure 28 and Figure 29 show a representation of the measurement shall be left floating. of the direct method. The 1kΩ (MD - equivalent to that used in the IEC 60601 standard –...
  • Page 30 RIGEL MEDICAL Applied part Current in µA (RMS) ∙ Class I and Class II 5000µA 50µA ∙ For defibrillation paddles Class CF 100µA Figure 30 - Applied part leakage current - direct method (a.c) Applied part leakage: Alternative method As live and neutral are shortened, the DUT is This method is in fact similar to a dielectric not directly connected to the mains potential.

  • Page 31: Measurements

    A PRACTICAL GUIDE TO IEC 62353 Applied part Current in µA (RMS) ∙ Class I and Class II 5000µA 50µA ∙ For defibrillation paddles class CF 100µA Figure 33 - Applied part leakage current - alternative method (a.c) Secondary earth problems Due to the fact that electrical currents follow the path of least resistance (much like water does), it is important to realise that secondary...
  • Page 32 RIGEL MEDICAL If the secondary earth path can’t be removed, 230V one should revert to the differential leakage method which is capable of measuring the total leakage even when a secondary earth 230V path exists. This is because the differential leakage method does not rely on a 1kΩ...

  • Page 33: Record Keeping

    A PRACTICAL GUIDE TO IEC 62353 Electrical safety testing is only part of the total Warning service carried out on medical equipment. No incoming Earth line. Can be used by:- 1. Earth Fault or 2. Once the safety is accessed, the functionality is IT System (Isolated Earth) verified and recorded before the equipment is Please check earth integrity before...

  • Page 34: Conclusion

    RIGEL MEDICAL provided in Appendix E. therefore leading to improved patient safety. Going forward, determining the appropriate Additional test setups such as the differential levels of both electrical and functional testing method and alternative method give the user a will be central to the introduction of cost valid measurement when circumstances might effective yet reliable preventative maintenance not allow for a valid test measurement under...
  • Page 35 A PRACTICAL GUIDE TO IEC 62353 Ensure accuracy and repeatability of leakage measurement readings. Some manufacturers might specify full scale accuracy which will effect the accuracy of low leakage measurements. Ensure that contact resistance is taken into account when measuring the earth continuity at low currents (<8A).

  • Page 36: Appendix A: Pass/Fail Limits Of Iec 62353

    RIGEL MEDICAL Appendix A: Pass/fail limits of IEC 62353 Applied part Current in µA (RMS) Equipment leakage – alternative method ∙ Class I equipment 1000µA 1000µA 1000µA ∙ Class II equipment 500µA 500µA 500µA ∙ For mobile x-ray generators 5000µA Equipment leakage –...

  • Page 37: Appendix B: Iec 60601

    A PRACTICAL GUIDE TO IEC 62353 Appendix B: IEC 60601-1 collateral standards Table 1 – IEC 60601 Collateral Standards (© IEC Geneva, Switzerland) IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests IEC 60601-1-3...

  • Page 38: Appendix C: Iec 60601 Test Standards

    RIGEL MEDICAL IEC 60601-1-12 Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment Appendix C: IEC 60601 test standards Table 2 –...
  • Page 39 A PRACTICAL GUIDE TO IEC 62353 IEC 60601-2-11 Medical electrical equipment - Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment IEC 60601-2-16 Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment IEC 60601-2-17 Medical electrical equipment - Part 2-17: Particular requirements for the basic safety and essential...
  • Page 40 RIGEL MEDICAL IEC 60601-2-25 Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs IEC 60601-2-26 Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs IEC 60601-2-27 Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment...
  • Page 41 A PRACTICAL GUIDE TO IEC 62353 IEC 60601-2-39 Medical electrical equipment - Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment IEC 60601-2-40 Medical electrical equipment - Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment IEC 60601-2-41 Medical electrical equipment - Part 2-41: Particular requirements for the basic safety and essential...
  • Page 42 RIGEL MEDICAL IEC 60601-2-54 Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy IEC 60601-2-57 Medical electrical equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use IEC 60601-2-62...
  • Page 43 A PRACTICAL GUIDE TO IEC 62353 Appendix D: Patient environment PG 43...
  • Page 44 RIGEL MEDICAL Appendix E: Example documentation template “Harm” is a defined term in ISO 14971:2000 as “physical injury or damage to the health of people or animals, or damage to property or the Environment” In IEC 60601, safe levels of current are defined as 10µA AC / DC for CF applied parts and 100µA AC / DC for B / BF applied parts and touch current.
  • Page 45 A PRACTICAL GUIDE TO IEC 62353 Products in the Rigel Medical range 62353+ Accurate and fast electrical safety tester ∙ Light, handheld, battery operation* ∙ Conforms to IEC 62353 / NFPA-99 ∙ Fully customisable test sequences ∙ Easy data entry and storage ∙...
  • Page 46 RIGEL MEDICAL Accessories and services from Rigel Medical Accessories Having the right accessories can streamline your testing processes and help you get the most from your instrument. Our range of accessories includes scanners, Bluetooth enabled printers, a variety of leads and adaptors, pass/fail labels and verification units. To see the full range of Rigel Medical accessories available, visit www.rigelmedical.com/accessories Training...
  • Page 47 A PRACTICAL GUIDE TO IEC 62353 Notes PG 47...
  • Page 48 Seaward, 15 -18 Bracken Hill, South West Industrial Estate, Peterlee, County Durham, SR8 2SW. United Kingdom T: +44 (0) 191 586 3511 E: sales@rigelmedical.com Rigel Medical Rigel Medical Rigel Medical Rigel Medical www.rigelmedical.com Rev 4.1...

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