The relationship between IEC 60601-2-18 and IEC 60601-2-37 - Ultrasound Project

[sankui]

Hello all,

We are ready to develop an ultrasound project. Several ultrasonic transducers will be developed, including common probes (e.g. abdomen) and the transesophageal probes (TEE probes).

The question is related to the TEE probe, because I was told that if the ultrasonic system with TEE probe, the system need to meet the IEC 60601-2-18: 2009 (endoscopic equipment) and IEC 60601-2-37: 2007 (ultrasonic equipment).

From the definition 201.3.203 and 201.3.206 in 60601-2-18, it seems reasonably to consider this standard to the ultrasonic equipment with TEE probe.

Clause 201.4.1.102 in 60601-2-18 states that for the ultrasonic safety aspects of ENDOSCOPIC EQUIPMENT which is also ULTRASONIC DIAGNOSTIC EQUIPMENT, that part which is intended for ultrasonic diagnosis shall comply with the requirements of IEC 60601-2-37 and the other parts shall comply with the requirements of this particular standard.

Furthermore, the rationale of clause 201.4.1.103 in 60601-2-18 also describes that the definition of ENDOSCOPIC EQUIPMENT includes invasive ultrasonic probes and their SUPPLY UNITS, used either with or without integral or separate viewing means. Whilst the electrical safety aspects of this type of MEDICAL ELECTRICAL EQUIPMENT are covered by this particular standard, the ultrasonic functional safety aspects are covered by IEC 60601-2-37.

However, it seems a bit strange if endoscopic standard appears on the CB certificate of ultrasonic system, because full certification to a standard should only be done when the equipment is clearly within the intended scope.

I wonder that whether both 60601-2-18 and 60601-2-37 shall be fulfilled when ultrasonic equipment has TEE probe.

 

[Peter Selvey]

It is likely that the scope of IEC 60601-2-18 has been written with a multifunction endoscope in mind (e.g. connects to a video processor, light source, ultrasound supply and/or HF surgical equipment).

In your case it may be only an ultrasound function (no camera, no channel for HF surgery, light source etc). So, while IEC 60601-2-18 may be technically applicable there is unlikely to be any significant tests or requirements.

But, there may be some small points. For example, Type B equipment is allowed in ultrasound, but not allowed for endoscopes.

So both -2-18 and -2-37 should be applied, with the -2-18 being largely a paperwork exercise.

 

[sankui]

Hello peter,

I agree with your comment. The diagrammatic explanation of configuration for endoscopic application can be derived from Figure AA.101 in Annex AA. This makes things more clear.

It is worth noting, besides the classification of applied part, ISO 8600-1 shall be taken into account.