iec 60601 - medical electrical equipment

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    Hand-Held dosing device has no PATIENT - Interpretation of the PATIENT definition

    Hi everyone, For the past year I've been working in a team developing a HAND-HELD dosing device for people that today administer their prescription drugs with pills or capsules. The idea is to load the device with pellets and then dispense pellets on the demand of the "patient". The reason for...
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    Tests IEC 60601-1 - Grounding Resistance, Leakage Current and Dielectric Rigidity in an automated way

    Good Morning! We are an electromedical manufacturer and would like to ask you a question, which device do you use to test the 60601 (Grounding Resistance, Leakage Current and Dielectric Rigidity) in an automated way? Example only one model of ours each lot is about 1,000 units, and according to...
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    IEC 60601-1, ed 3.1 - Blue icon question

    Some of the product we sell is IEC 60601-1, ed3.1 and proper labeling is applied. Is there any restrictions if the blue icon was placed on a 2nd edition product?
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    Applicability of ISO 14708-3 - RF transmitter and implantable RF receiver

    Referring to section 27.102(f) of 14708-3: 2008 version: Our device which is a Class III device and falls under the category of "non-implantable RF transmitter and implantable RF receiver", based on the verbiage above, need not go through 14708-3 section 27 testing per this version of the...
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    IEC 60601-1-2 Radiated Immunity Test - Diagnostic ECG device

    We are planning to test our portable 3.7V Battery operated Diagnostic ECG device for Electromagnetic Compliance. As per Radiated Immunity Test requirement mentioned IEC 60601-2-25, Section 202.6.2.3, the test should be carried out by feeding CAL20110 waveform and the following compliance...
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    Determination of TENSION SAFETY FACTORS - Table 21 IEC 60601-1

    Hello all! I would like to know if anyone has experience in determining the safety factor, in our case it is a rotation where the testing laboratory considered the elongation less than 5%, I have already tried in several forums and I do not get material on metal material enlogging. Rodizio...
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    In which country is essential to have and IEC 60601 CB Report?

    Although there are 50 CB Scheme member countries, it is not always necessary for approval of products. I`d like to know in which country is essential to have 60601 CB report? I heard about south korea...
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    The necessity of a SECONDARY CIRCUITS in ME EQUIPMENT (IEC 60601-1)

    Hello, As far as I know, there is no direct requirement in IEC 60601-1 that the ME EQUIPMENT has a SECONDARY CIRCUIT. Am I right? To be more specific let's imagine the flyback converter with D2Dn LED array as a load (see the picture). Capacity of C1 and the charge voltage are quite big, say...
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    Is Compliance Testing of IEC 60601-2-63 mandatory for Europe - Dental X-Ray machine

    Hi, As we are manufacture of medical products Class IIB and manufacture dental X-Ray machine. I am new to this product and during testing i have a query for testing of IEC 60601-2-63. when i saw the predicate devices and i found IEC 60601-2-63 in their compliance table which Is Medical...
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    IEC 60601-1-9 Compliance mendatory or Not - CT Scan machine

    Hi Everyone. As we are manufacture of Medical X-Ray equipment and Manufacture the Computed tomography Scan machine. As i new to this product and Compliance testing for this product is all under to me. When i saw the compliance table of predicate devices there i notice IEC 60601-1-9 which is...
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    Connection between IEC 62304 and Chapter 14 of IEC 60601-1

    Hello, everyone, I would like to understand the connection between chapter 14 and IEC 62304 in connection with CB testing Is it true that the testing laboratory does not review the software documentation if chapter 14 is not applicable? (If Software does not affect Basic Safety or Essential...
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    IEC 60601-1 - Essential performance doesn't make sense

    Hello, When determining essential performance, the guidance in 60601-1 is to assume with 100% certainty that a device's performance has degraded beyond some limit (determined by the manufacturer) which results in unacceptable risk. In reality if this was to happen, since a patient is getting...
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    ECoG/EEG electrodes - Required IEC 60601-1 tests

    We develop strip electrodes for Electrocorticography and motor evoked potentials (recording and stimulation), they are BF applied parts. To be used the device is placed in contact with the brain surface and is connected to a connecting cable (CE marked) which is then connected to Intraoperative...
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    IEC60601-1: Isolation for an applied part with working voltage of 1500Vp.

    How much Isolation voltage will be required if the applied part has a working voltage of 1500Vp. Do I need 7121 RMS (2 MOPP). My device has BF applied part.
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    External power supply - requirements in safety/EMC test?

    Hi all, We're developing a medical humidifier - to be used in hospitals (no home use). In case we'll plan the device to be with an external power supply unit, will it change any applicable standard requirements (as compared to a device with an internal power unit) ? I guess it will be relevant...
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    IEC 60601-1 Humidity Precondition Test

    Dear all, We are working on diagnostic ecg device with a plastic enclosure. The Humidity test mentioned in IEC 60601-1 , is it a Condensing humidity test or non condensing humidity test. And I had read in previous posts that we need to take the readings once during the device is placed at...
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    IEC 60601-1-2 immunity to proximity fields Test setup - Diagnostic ECG device

    Dear all, Is the test setup for the Immunity to proximity fields same as the Radiated Immunity test. The only difference between these two tests are the frequency bands at which device is tested. Is there any other differences,,,?
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    IEC 60601-1-2 - RF Conducted Immunity Test Setup - Diagnostic ECG device

    Dear all, I could not find test setup for RF conducted Immunity. Since, Conducted immunity is about inducing disturbance on ECG cables and checking if the there is any degradation in performance. Does the setup for the RF radiated immunity (Where ECG DUT is connected to Simulator and CAL...
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    IEC 60601-1-2 Radiated E-Field Emission Testing - Diagnostic ECG device

    Dear all, During the Radiated E field Emissions Testing, do we need to run the functional test continuously. We are working on a diagnostic ECG device. During the testing we are planning to connect the ECG device with simulator and monitor ecg on a Tablet through wireless interface. During...
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    IEC 62133 cell vs. Battery Pack - Certification on the cell only

    We are a medical device manufacturer using an IEC62133 certified, single cell Li-ion battery pack (not user accessible) for a portable device. The pack we are using is no longer going to be available and we are in the market for a replacement. I am able to find replacement packs that have...
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