IEC 60601-1 Main Power Cord Requirement

[hongkai0818]

Hi all, I am new to medical device. We are a medical device startup and we are currently developing a device for rehabilitation. For our device, we are using a common DC jack 12 V for power input. To fulfill the IEC 60601-1 requirement, we have selected a IEC60601 approved AC/DC power supply. However, generally the power supply does not come with the main power cord. The power supply suggested using iec 320 2 pin connector for the main power cord.

May I know if we select main power cord separately, do we need to subject the main power cord to additional tests in order to fulfill the IEC60601 standard?

 

[Pads38]

Clause 8.11.3.4 states that Appliance Couplers that comply with IEC 60320 are considered to comply with the requirements of 60601.

You also need to show that your cord conductors are big enough - see table 17.

And 8.11.3.2 requires that your cord be as robust as a PVC cord type.

Generally, as long as you use a certified cord you will be OK. Also to take into account is the requirements for Protective Earth connections - but as you mentioned a 2-pin connection that probably does not apply to you.

For US / Canada having a cord that is UL recognised makes things easier. Note you may also need a cautionary note about grounding integrity requiring a 'hospital' grade connection.

Welcome to the Cove!

 

[hongkai0818]

Thanks Pad for your reply.

May I know what are the requirements for protective earth connections if we choose a appliance coupler with C14 connection?

 

[Pads38]

The main consideration for the earth connection is that the impedance needs to be low - from the earth pin to parts that are Protectively Earthed needs to be below 0.2 ohms; measured with a test current of 25A, ideally with a 3m long lead.

These requirements are not usually a problem if you are using leads as set out in Table 17 (see above).

The test clause is 8.6.4