Hi All,

Just trying to clear up an issue regarding the use of Luer Lock connectors on NiBP cuffs and systems. Under EN1060-3 the Luer Lock connector is excluded on safety grounds, but I've seen cuff manufacturers selling the Luer Lock on cuffs that have the CE Mark. Indeed some system manufacturers like Colin and Data Scope still appear to supply such a connector. How do you guys interpret EN1060-3 in this case?

Your opinions and experiences would be appreciated.

My opinion is that the CE mark is worthless, and should be ignored. If I'm wrong, why do I see so many of these stickers on junk in car-boot sales?

Actually (as has been mentioned on this forum before), "valid" CE marks have a reference number attached (for those who may wish to look up the original citation).

Richie 1485,

"Low-risk" CE marked medical devices may be constructed so that they do not necessarily meet all the requirements of published standards nor adhere to established best pratice because manufacturers may consider that the risks associated with the device are acceptable and be able to provide a rationale for this.

For devices classified as low risk this sort of issue should not be a problem since the likely outcome of a problem due to a failure to adhere to certain requirements will be of little consequence. However for a blood pressure measurement device I'd have thought that it'd be wiser for manufacturers to adhere to safety requirements of connectors published in applicable standards.

Given the potential for difficulty in disconnection if a problem occurs, the potential for leaks producing erroneous or unreliable BP determinations and the possibility of inexperienced or inadequately trained operators connecting the NBP device to vascular access devices via luer lock connectors, for example.

You'd have to ask the manufacturer to justify why the standards have not been adhered to, if the requirement(s) of the standard appear to be applicable to the product. Then to approach the MHRA if you're not satisfied with the answer from the manufacturers regulatory affairs representative.


Are you certain the products you're querying were designed and manufactured to meet the standards you're referring to, i.e. that the standards are applicable? Are you certain that the connectors being used are actually Luer locks, i.e. they have Luer lock dimensions that allow them be inadvertently connected to vascular access devices, thus present a significant risk, for example?

Dear Mr Ling,

Thanks for your reply. I am specifically coming from the safety side of the regulation relating to connecting a NiBP device to a vascular access device. EN1060-3 only states that "Luer Lock connectors are not to be used", and does not specify any size or dimension. I am sure the cuff manufacturer is using Luer lock because they state it in their literature. They also state that is is suitable for use with a range of monitors/cuff combinations which I have seen used in the UK. I don't have enough knowledge of the vascular equipment side to comment about interconnectivity with the NiBP devices. The products that I am referring to carry the CE mark, therefore you would assume that they would comply with the relevant standards under MDD.

I think the point I'm making is whether the device can actually be connected to a vascular access system with the connector that's currently fitted - if not then the "Luer lock" device fitted to the BP monitor does not present a safety issue of the nature described in the standard.

Standards are used by manufacturers as a means of demonstrating the application of best/current practice/"state of the art" manufacturing practices, etc, etc. So that basic safety and performance of the device meets established requirements and this allows safety and performance of devices to be more easily verified.

The manufacturer is obliged to meet an equivalent level of safety to the standard or better if the choice is made not to apply the standard "to the letter" - this may mean using a "Luer lock" type of connector that has different dimensions to a standard luer lock used with vascular access devices, for example.

If the BP device does use a standard luer lock and can be connected to luer locks used for vascular access, for example, and the standard is applicable to the device then I'd be concerned.

Hi Mr Ling,

Thanks for your swift reply. The standards are open to a degree of interpretation as written, so it looks like I am going to have to do some more homework.

Thanks again

You can have a look on the following documents (if you have not already done so) to get more informatiuon on the subject:

CEN CR 13825, Luer connectors - A report to CEN chef from the CEN forum task group “Luer fittings”

EN 15546-1. Small bore connectors for liquids and gases in healthcare applications. Part 1: General requirements

ISO 80369-2 Ed2: Small-bore connectors for liquids and gases in healthcare applications - Part 2: Connectors for breathing systems and driving gases - this is still in draft and is a revision of En 15546-1

This last one is the only one i have, but the three documents have almost the same text (and so this last revised one is the best). It has a table which details the possible connections of equipment and a risk analysis made on them.

Quoting from the document:



In the end, you could always do a risk management yourself of the connectors you use, if the connector manufacturer hasn´t done so. :-)))

Interesting enough, i was just cross-browsing some references and found a way to do just that on the hospital environment, in a structured way:
Using HFMEA to assess potential for patient harm from tubing misconnections

(Hope the link works, i´m not sure if you have to subscribe).

The .pdf downloaded just fine, Marcelo. Thanks for that.

Annnnnnnd i forgot to tell, i found the above document after i found a compiled list of (mis)connectors papers and docs: Small Bore Connectors Reference List.

That´s why i love Google...