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As the rules change or new procedures are developed, please note that these interpretation and/or guidance may not apply; you should always refer to the latest rules and guidance documents to determine what equipment authorization procedures should be followed. For the latest guidance on specific topics or you don't know where to start, please feel free to contact GTG experts.

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GTG Group can help you with medical power supplies (MPS) testing & certification.
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Medical Power Supplies (MPS) are specialized power supplies that are designed to provide reliable and safe power to medical devices. MPS must meet strict regulatory standards to ensure their safety and reliability.

How can GTG assist you with the tests on medical power supplies?

As GTG Group’s strategy updates, some of the below listed test items may no longer be available, please contact us for the latest information.

(1) Electrical safety test

  • Insulation resistance test: the test is one of the most important electrical safety tests for medical power supplies. During this test, the power supply is tested to determine if there are any electrical leaks in the insulation. This test is carried out by applying a high voltage to the power supply and measuring the resistance. If the resistance is too low, it indicates that there is a leak in the insulation.
  • Dielectric withstand test: the test is another critical electrical safety test for medical power supplies. In this test, the power supply is tested to determine if it can withstand a high voltage without breaking down. This test is carried out by applying a high voltage to the power supply for a specific amount of time. If the power supply can withstand the voltage without breaking down, it passes the test.
  • Ground continuity test: the test is carried out to ensure that the ground connection of the medical power supply is intact. During this test, a low voltage is applied to the ground connection of the power supply, and the resistance is measured. If the resistance is too high, it indicates that the ground connection is broken.
  • Leakage current test: the test is carried out to ensure that the medical power supply does not leak any current to the patient. During this test, the power supply is connected to a patient simulator, and the current flowing through the patient simulator is measured. If the current is too high, it indicates that the power supply is leaking current.
  • Input current test: the test is carried out to ensure that the medical power supply does not draw too much current from the power source. During this test, the power supply is connected to a power source, and the current drawn by the power supply is measured. If the current is too high, it indicates that the power supply is drawing too much current.
  • Output voltage test: the test is carried out to ensure that the medical power supply is providing the correct voltage to the medical device. During this test, the power supply is connected to a load simulator, and the voltage output is measured. If the voltage is too high or too low, it indicates that the power supply is not providing the correct voltage.
  • Overload test: the test is carried out to ensure that the medical power supply can handle a load that is higher than its rated load. During this test, the power supply is connected to a load that is higher than its rated load, and the current draw is measured. If the power supply can handle the overload without breaking down, it passes the test.
  • Short circuit test: the test is carried out to ensure that the medical power supply can handle a short circuit without breaking down. During this test, a short circuit is created across the output terminals of the power supply, and the current draw is measured. If the power supply can handle the short circuit without breaking down, it passes the test.

(2) EMC test

The International Electrotechnical Commission (IEC) is responsible for setting the standards for EMC testing. The two standards relevant to medical power supplies are IEC 60601-1-2 and IEC 61000-4. EMC test is the process of evaluating the ability of electronic devices to function properly in their intended electromagnetic environment and to avoid electromagnetic interference (EMI) with other devices.

  • Radiated emissions test: the test measures the amount of electromagnetic radiation emitted by the power supply when in operation. The test ensures that the power supply does not interfere with other medical equipment in the vicinity.
  • Conducted emissions test: the test measures the amount of electromagnetic radiation emitted through the power supply’s conductive elements. This test ensures that the power supply does not interfere with other devices connected to the same power source.
  • Radiated immunity test: the test measures the power supply’s ability to withstand electromagnetic radiation from other devices. This test ensures that the power supply remains operational even in the presence of other medical equipment.
  • Conducted immunity test: the test measures the power supply’s ability to withstand electromagnetic interference through its conductive elements. This test ensures that the power supply remains operational even when connected to devices that emit electromagnetic interference.
  • Electrostatic discharge test: the test measures the power supply’s ability to withstand electrostatic discharge, which can occur when a patient or medical staff touches the power supply. This test ensures that the power supply remains safe and operational even in such scenarios.
  • Voltage dip and interruption test: the test measure the power supply’s ability to withstand voltage dips and interruptions in the power supply. This test ensures that the power supply remains operational even when the power supply experiences temporary voltage dips or interruptions.
  • Surge test: the test measures the power supply’s ability to withstand sudden voltage surges, which can occur due to lightning strikes or power grid fluctuations. This test ensures that the power supply remains operational even in such scenarios.
  • Power frequency magnetic field test: the test measures the power supply’s ability to withstand magnetic fields generated by power grids. This test ensures that the power supply remains operational even in such scenarios.
  • Voltage fluctuation flicker test: the test measures the power supply’s ability to withstand voltage fluctuations that can cause flicker, which can be harmful to patients. This test ensures that the power supply remains safe and operational even in such scenarios.
  • Voltage variation test: the test measures the power supply’s ability to withstand voltage variations that can occur due to changes in the power grid’s load. This test ensures that the power supply remains operational even in such scenarios.

(3) Mechanical tests

  • Shock and vibration tests: the tests are conducted to assess the MPS’s ability to withstand sudden impact and vibrations that can occur during transportation or installation. These tests involve subjecting the MPS to a series of shocks and vibrations of varying intensity to simulate real-world conditions. The MPS is evaluated for any damage or malfunction after each test.
  • Drop test: the test evaluates the MPS’s ability to withstand accidental drops that can occur during use. The MPS is dropped from a specified height onto a hard surface, and its ability to function correctly is evaluated. This test is critical as it ensures that the MPS does not pose any risk to patients or healthcare professionals in case of accidental drops.
  • Tensile test: the test evaluates the MPS’s ability to withstand tensile stress, which occurs when the MPS is pulled in opposite directions. This test is essential as it ensures that the MPS’s internal components, such as wires and connectors, do not break or malfunction under stress.
  • Compression test: the test evaluates the MPS’s ability to withstand pressure and compression that can occur during transportation or use. The MPS is subjected to a series of compression tests of varying intensity, and its ability to function correctly is evaluated.
  • Impact test: the test evaluates the MPS’s ability to withstand impact forces that can occur during use. The MPS is subjected to a series of impact tests of varying intensity to simulate real-world conditions. The MPS is evaluated for any damage or malfunction after each test.

(4) Environmental tests

  • Temperature test: the test involves subjecting the MPS to a range of temperatures to determine its performance under different conditions. The purpose of temperature testing is to identify any potential issues that may arise due to exposure to extreme temperatures. This type of testing is critical in ensuring the safe and reliable operation of medical devices, as temperature fluctuations can affect the performance of the MPS and ultimately impact the safety of patients.
  • Humidity test: the test involves subjecting the MPS to different humidity levels to determine its performance under varying conditions. Humidity testing is essential in identifying potential issues that may arise due to exposure to high humidity levels, which can cause corrosion, condensation, and other issues that can affect the performance of the MPS.
  • Dust test: the test is carried out to assess the impact of dust on the performance of MPS. Dust can accumulate on MPS and result in decreased performance or even failure. During dust testing, MPS is exposed to a controlled amount of dust to determine how it performs under those conditions. The testing is carried out in accordance with industry standards, and the results are used to improve the design and quality of MPS.
  • Water test: the test is carried out to assess the impact of water on the performance of MPS. This testing is important because MPS can be exposed to water during their use, and if they are not designed to withstand the exposure, they can fail. During water testing, MPS is exposed to controlled amounts of water to determine its performance under those conditions. The testing is carried out in accordance with industry standards, and the results are used to improve the design and quality of MPS.
  • Altitude test: the test is designed to test the performance of MPS under low-pressure conditions that are similar to high altitudes. The test is conducted in a low-pressure chamber where the air pressure is gradually reduced to simulate high altitude conditions. The test aims to ensure that the MPS can operate at high altitudes without any malfunction or damage. The test also checks if the power supply can maintain its output voltage and frequency under low-pressure conditions.
  • Fire test: the test is designed to test the ability of MPS to withstand fire and prevent it from spreading. The test is conducted in a fire chamber where the power supply is subjected to a controlled fire. The test aims to ensure that the MPS can operate even when exposed to fire. The test also checks if the power supply can prevent the fire from spreading to other medical devices.
  • IP test: the IP (Ingress Protection) test is designed to test the ability of MPS to withstand water and dust ingress. The test is conducted in a chamber where the power supply is subjected to water and dust at various pressure levels. The test aims to ensure that the MPS can operate in harsh environments without any damage. The test also checks if the power supply can prevent water and dust from entering the device.
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How can GTG assist you with the certifications or markings for medical power supply?

(1) CB scheme

The CB scheme is an international certification program that provides a standard for the safety and performance of electrical and electronic equipment. Compliance with the CB scheme ensures that the MPS meets global safety standards.

(2) UL certification

UL (Underwriters Laboratories) is an independent safety science company that provides testing, certification, and inspection services. UL certification ensures that the MPS meets the UL 60601-1 standard, which is the international safety standard for medical electrical equipment. The UL certification includes testing for electrical safety, mechanical safety, and fire safety.

(3) CSA certification

CSA (Canadian Standards Association) is a Canadian organization that provides standards development, testing, and certification services. CSA certification ensures that the MPS meets the CSA C22.2 No. 60601-1 standard, which is the Canadian safety standard for medical electrical equipment. The CSA certification includes testing for electrical safety, mechanical safety, and fire safety.

(4) CE certification

CE (European Conformity) is a mandatory certification mark for products sold in the European Economic Area (EEA). The CE certification ensures that the MPS meets the requirements of the European Union’s Medical Device Directive (MDD) or the In Vitro Diagnostic Device Directive (IVDD). The CE certification includes testing for electrical safety, electromagnetic compatibility (EMC), and biocompatibility.

(5) IEC certification

IEC (International Electrotechnical Commission) is an international standards organization that develops and publishes standards for electrical and electronic devices. The IEC certification ensures that the MPS meets the IEC 60601-1 standard, which is the international safety standard for medical electrical equipment. The IEC certification includes testing for electrical safety, mechanical safety, and fire safety.

(6) FCC certification

FCC (Federal Communications Commission) is a US government agency that regulates the use of radio frequency (RF) devices in the United States. The FCC certification ensures that the MPS meets the FCC Part 15 standard, which is the US standard for RF emissions. The FCC certification includes testing for RF emissions and immunity.

(7) RoHS certification

RoHS (Restriction of Hazardous Substances) is a European Union directive that restricts the use of certain hazardous substances in electrical and electronic devices. RoHS certification ensures that the MPS is free from lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls (PBB), and polybrominated diphenyl ethers (PBDE).

(8) WEEE certification

WEEE (Waste Electrical and Electronic Equipment) is a European Union directive that regulates the disposal of electrical and electronic devices. WEEE certification ensures that the MPS is designed and manufactured in a way that allows for the safe disposal or recycling of the device at the end of its life.

(9) ISO certification

ISO (International Organization for Standardization) is an international standards organization that develops and publishes standards for various industries, including healthcare. ISO certification ensures that the MPS meets the ISO 13485 standard, which is the international standard for quality management systems for medical devices. The ISO certification includes testing for quality management, risk management, and regulatory compliance.

(10) IAF accreditation

IAF (International Accreditation Forum) is an international accreditation organization that provides accreditation services for certification bodies. IAF accreditation ensures that the certification body providing the MPS certification meets the requirements of ISO/IEC 17021-1, which is the international standard for accreditation bodies auditing and certifying management systems.

(11) MDSAP certification

MDSAP (Medical Device Single Audit Program) is a program that allows medical device manufacturers to undergo a single audit to satisfy the regulatory requirements of multiple countries, including Australia, Brazil, Canada, Japan, and the United States. MDSAP certification ensures that the MPS meets the regulatory requirements of the participating countries.

(12) FDA 510(k) clearance

The US Food and Drug Administration (FDA) requires that all medical devices sold in the United States be cleared or approved by the FDA. For MPS, this clearance is obtained through the 510(k) process, which requires the manufacturer to demonstrate that the MPS is substantially equivalent to a legally marketed device.

(13) REACH compliance

REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) compliance is a European Union regulation that addresses the production and use of chemical substances. MPSs that comply with REACH do not contain certain hazardous chemicals.

(14) IEE certification

IEE (International Energy Efficiency) certification ensures that the MPS meets energy efficiency standards set by international organizations. MPSs with IEE certification are more energy-efficient, which can lead to cost savings.

(15) MDD compliance

The MDD (Medical Device Directive) is a European Union directive that regulates medical devices. MPSs used in medical devices must comply with the MDD.

(16) JIS certification

JIS (Japanese Industrial Standards) is a certification organization that tests and certifies MPSs for use in Japan. MPSs with JIS certification have been tested for safety and performance, and comply with Japanese safety standards.

Got questions on medical power supplies certification? We are always here to help, just ask!

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Why the biggest brands trust GTG Group?

GTG Group (Global Testing Group) is a certification company that offers testing and certification services to different industries. Our expertise in medical power supplies testing and certification has made us a trusted name in the industry.

(1) Independent and impartial testing

GTG Group is a third-party testing company, which means we are not affiliated with any specific manufacturer. This impartiality can provide camera manufacturers and consumers with confidence in the accuracy and reliability of the testing process, and ensure that the camera meets the required standards.

(2) Confidentiality and security

GTG Group understands the importance of confidentiality and security when it comes to testing and certification. We ensure that our clients’ data and information are kept confidential and secure at all times. This ensures that our clients’ intellectual property and trade secrets are protected.

Contact GTG Group today for medical power supplies testing and certification to avoid any legal issues that may arise from using a faulty medical power supply.

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