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medical device electronics and electrical equipment

  1. N

    Creepage - Does a surface mount isolator body negate a PCB slot?

    Hi, I am trying to replace a bulky potted isolator with a surface mount digital isolator. For a standard FR4 PCB we have been working to a creepage of 16mm. There is a high creepage isolator from TI with a 14.5mm creepage distance and a body CTI of >600. This part should be very suitable for...
  2. M

    Oxygen enriched environment applicability - Operating table used in general surgeries in hospital

    Hi all, there is an operating table which is used in general surgeries in hospital. as far as I am concerned, the sub-clause 11.2 Fire prevention of 60601-1 relates to circuits which are suitable in the presence of Oxygen with the amount greater than 25%. is it correct to consider that device...
  3. L

    PC in patient environment - BF applied part that uses USB to connect to PC

    Hello, It is my first post and I would like to say hello to every one. In my device I have BF applied part that uses USB to connect to PC. I will use USB isolator between applied part and PC that have 2MOPP (for signal and power). Applied part hasn't direct contact with patient skin, only...
  4. W

    Body-worn brain stimulator (MOPP isolation requirements)

    Hi All, We have a medical device which is body worn for >30d. It is essentially a electrical brain stimulator. It have a plastic enclosure and two patient leads which will be implanted into patient during clinical use. The device will generate a (0-11.5mA/1.1Hz ) current to sitmulate patients...
  5. V

    2MOP of mains voltage is required between 2nd Circuity and Accessible parts?

    Hi, If a secondary circuit with 5V supply is referenced to earth in normal condition, the insulation between operator accessible part and secondary circuitry (e.g. power off button) is subject to 5V. However, in SFC where earth disconnected, the secondary voltage may reach mains voltage due to...
  6. L

    Requirements for cables used with Medical Devices

    Hi all, I would like to know which requirements apply to standard cables that are available on the market and used together with medical devices. It is clear that RoHS must of course be considered. The cables may be simple cables such as Ethernet, HDMI, PS/2, Displayport. These could be used...
  7. K

    Is a 3V torch classified as medical electrical equipment needing EMI/EMC testing?

    We have made a Class I (CE) metal medical instrument that has a plastic handle. With use, doctors requested a light option to improve visibility and to free up the hand holding the torch. We have incorporated a simple push switch and small light powered by standard 3V AAA batteries. The...
  8. Q

    Applicable Medical Device Wifi regulations for various Countries

    What are the regulations applicable if Wireless (Wifi) module part of Medical Device for the following countries? Argentina Australia Brazil Canad Caribbean Chile China Colombia Hong Kong Israel Japan Korea Malaysia Mexico New Zealand Nordic Norway Peru Philippines Puerto...
  9. S

    Clarification regarding tests in IEC 60601-2-25

    I am new to testing the ECG device as per IEC 60601-2-25 standard. I want to test a battery operated ECG device, which can work in 6 lead or 12 lead mode. I have gone through the IEC60601-2-25 document and have few aspects that needs clarification. 1. In the indication of Inoperable ECG...
  10. I

    Reuse PCBs in a Medical Device

    Hi folks, Do you know what are the requirements for reusing PCBs (Printed Circuit Boards previously installed in a medical device) in new ones?. The focus of interest is EU and US and the standard used is the ISO 13485. Thank you in advance
  11. L

    Valid reasons to omit an "ear-tag" type label on a cable?

    Dear Experts, Our cables/accesories do not have enough space to attach all required labeling, and for this clause 7.2.4 of IEC-60601-1{ed3.1}(2012) states: Depending on which NB auditor I speak to we are or are not obliged to attach a flap-type label to these cables. We argue through usability...
  12. E

    IEC 60601 Main requirements for the certification of a device with a Li-ion batt

    Dear. I need help in the following question: Dear. I need help in the following question I work in the development of a wearable device and its main use is to record ECG signals. This is powered by a 3.7V Li-ion battery. This battery is not accessible to the user, but to charge it through...
  13. I

    SMD line PQ Validation

    Hi Folks, I need some help regarding SMD line PQ validations. How many product units would be needed to go through a PQ validation?. What kind of standards can we follow for Europe and the US? Do I need only one lot or three lots? Let's say, the final product is a glucometer point of care...
  14. S

    IRAM 2006 and compliance

    Hi, Does anyone know where I can purchase IRAM standards. I couldn't find anywhere provide this standard. I will need IRAM 2006, which is the Argentina power plug standard. Also, can anyone tell me if plug on medical device sold in Argentine needs to be compliance with IRAM 2073 or just...
  15. M

    PCBA Drawing Best Practices IPC Class 3

    Hello community and experts in PCBA drawings. I am looking for best practices on what to include in the drawings notes, etc. a. Good statements related to IPC Class 3. b. Notes related to Lead Free Solder, etc. c. Cleanliness requirements & levels d. Any other tips, would be helpful...
  16. JoCam

    Medical Device that is class II electrical and IEC 60601-1-11

    Hi All, Standard IEC 60601-1-11 states that medical electrical equipment used in the home care environment, if it is not permanently installed, will need to be a class II electrical device. Does this mean that a class I electrical device can no longer be called medical electrical equipment if...
  17. rothlis

    Components in parallel to creepage\clearance

    The fifth paragraph of IEC 60601-1/A1:2012 clause 8.5.1.3 specifies the requirements for each means of protection (MOP). The third bullet point says "components that are connected in parallel with an insulation, with an AIR CLEARANCE or with a CREEPAGE DISTANCE comply with 4.8 and 8.10.1"...
  18. B

    Mains fuses and OVER-CURRENT RELEASES

    8.11.5 * Mains fuses and OVER-CURRENT RELEASES A fuse or OVER-CURRENT RELEASE shall be provided in each supply lead for CLASS I ME EQUIPMENT and for CLASS II ME EQUIPMENT having a functional earth connection according to 8.6.9, and in at least one supply lead for other single-phase CLASS II...
  19. O

    Difference in 60601-1-2 3rd and 4th ed separation RF portable equipment

    Hi, What is the separation distance that is allowed between MEDICAL EQUIPMENT OR MEDICAL ELECTRICAL EQUIPMENT and RF portable communication equipment in 4th edition of 60601-1-2 compared to 3rd edition? 4th edition calls out that for RI testing per table 9. But what is the minimum distance...
  20. E

    Are EEG electrodes considered as one applied part?

    Hi, I am a little confused and would like to ask about EEG electrodes, are they considered as one applied part or every single electrode is different applied part? Applied Leakage current test methods depends on how these electrodes are defined. What I found in 601-1 3rd ed. is that "the...
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