ECG Cable Banana to Snap or Tab electrode Adapters -- ISO 10993 Requirement

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Hi All,

We have an ECG Cable with Banana type Patient end connector. We are planning to purchase a "Banana to Snap Type adapter" and "Banana to TAB Electrode type adapter".

Banana to Snap adapter will not come in contac with patient body. However, "Banana to Tab electrode" will come in contact with patient body due to the
Can anyone clarify, if the adapters need to be certified as per ISO 10993 Standard.
 

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