Supplementary equipotential earth bonding points for Group 1 medical locations

BS7671 clause 710.415.2.1 requires that in each medical location of Group 1  activity, supplementary equipotential bonding connection points shall be installed.

It states: Supplementary equipotential bonding connection points for the connection of ME equipment shall be provided in each medical location, as follows: Group 1: a minimum of one per patient location.

For a consulting room in a Healthcare Centre, where patients will walk in and:

- the patient is only seeing a consultant for an appoint so is not in the room for any period of time

 - the patient is typically in reasonably health and does not been supported/assisted in seeing the consultant

 - there are no invasive procedures.

 - the equipment being used is a blood pressure monitor, (type BF as defined in BS EN 6061)

Is the Supplementary equipotential bonding connection point needed - as there is no availabe connection point on the equipment to connect to the bonding connection point. ?

 

Is a deviation from the regulation permitted as long as the reason is stated on the test certificate?

Parents
  • there are no invasive procedures.

     - the equipment being used is a blood pressure monitor, (type BF as defined in BS EN 6061)

    Clarification is required here. I cannot find BS EN 6061, but BS EN IEC 60601-2-34 refers to, "invasive blood pressure monitoring equipment" (my emphasis). Part 2-30 refers to, "non-invasive sphygmomanometers", but I can see no mention of, "type BF".

    ETA: I have now found a reference to, "applied parts" and, "type BF" in BS EN 80601-1 and of course, there is the definition of, "applied part" on page 37 of BS 7671:2018+A2:2022.

    So what sort of blood pressure monitor are you referring to?

  • The regulation is this one

    The reference is here

    The equipment is as below

Reply Children
  • Simon, I fear that AI has been unhelpful again, but the various standards could be clearer.

    Your description in the OP seems to be a perfectly ordinary consulting room (what the Americans call an "office") as opposed to a treatment room. I remain to be convinced that an ordinary sphygmomanometer is an applied part, in which case the location is Group 0. However, it's use could change and it is probably as well to treat as Group 1.

    I think that care needs to be taken with the term, "blood pressure monitor". Part 2:34 of BS EN IEC 60601 applies to equipment which uses a transducer which has been inserted into an artery and is connected by wires. Clearly, that poses a risk in the event of malfunction.

    The definition of a sphygmomanometer is very brief in OED: An instrument for measuring the force of the pulse. Strictly speaking, it measures the blood pressure only indirectly. So the pressure which blocks the flow of blood in a cuff around the arm is just above the peak blood pressure (systolic). How such a cuff, which is attached to the medical equipment by rubber tubes, could present a risk of shock is completely beyond me.

    I assume that in the consulting room, the consultant will take the blood pressure once (or take the average of two or three readings) rather than monitoring it during the whole consultation. That said, modern sphygmomanometers can take intermittent readings where monitoring is essential (e.g. during surgery).

    I venture to suggest that the definition of, "applied part" needs to be reviewed. Clearly, there is a difference between an applied part, which makes electrical contact with a patient, and one which cannot. A good example of one which does is an e.c.g. machine.

    The definition of, "medical equipment" can get absurd. For example, your ears feel blocked, so off you go. Doc has a look in your ears with an electrically powered otoscope. Mains-powered ones are available, but most would have a 3 V battery in them. As I read it, the otoscope is an example of an internally powered medical equipment. Doc finds some wax, so removes it with a sucker (nobody syringes ears nowadays) which is connected to a mains-powered pump. Technically, this is an applied part, but there can be no shock risk down a yard or so of plastic tubing. Then you have a hearing test: once again, the headphones appear to be an applied part. It's mad!

    I thought that this article is very clear and sensible. So, unless I have misunderstood the situation, your blood pressure monitor is not BF.

    Incidentally, I have seen those SEEB sockets many times, but I have never seen one connected to anything; and as you point out, if there is no pin on the ME, it cannot be connected.

    My apologies for rambling on, but I hope that this helps.