IEC 60601-2-24 & ISO 8536-8 - Conflicting Requirements?

H

hevak

Dear All,

Is anyone able to help provide some clarification/assistance regarding what appear to be conflicting requirements for infusion set/pump performance and labeling requirements as described in ISO 8536-8 and IEC 60601-2-24?

Specifically, ISO 8536-8, under 6.14 describes that storage volume is to be determined in accordance with IEC 60601-2-24 and declared in labeling in accordance with ISO 8536-8 10.1(h). However IEC 60601-2-24 describes that the testing is to be performed at 20C +/- 2C / 65%RH +/- 5%RH, while ISO 8536-8 10.1(h) describes that the storage volume should be stated at 40C.

Any assistance on this would be greatly appreciated.
 
Marc

Marc

Fully vaccinated are you?
Leader
A quick "Bump". I know this thread is kind of old, but any help will be appreciated! My Thanks in advance!
 
H

hevak

Thank you for the "Bump" Marc.

I've received a written response from ISO that they are aware of the conflict and are currently working on a technical document to provide guidance.

In the meantime I have advised my client that the best approach in this particular case should be risk-based and linked with the intended use of the device. In this case they also export the device to the European market and therefore they should also be aware that the ISO standard is a harmonized standard and that the IEC standard is not.

As soon as I'm aware that the technical document has been published I will add a link on the forum for reference purposes for other members.
 
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