ISO 10555-4 specifies requirements for balloon dilatation catheters supplied in sterile condition and intended for single use.
Unless otherwise specified in this part of ISO 10555, balloon dilation catheters shall comply with ISO 10555-1. The position of the balloon should be radio detectable when the catheter is inserted into the body.
The nominal size of the catheter will be indicated as follows;
Balloon Dilatation Catheter test requirements;
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