Krishna,
breached or compromised skin: opposite of intact or undamaged skin.
In case you do not get in contact with circulating blood, collecting blood samples does not introduce additional biological hazards to the list above.
@Chris: Depending on your notified body, their stance on "state of the art" may over-rule the concept of harmonized standards, since the harmonization process for medical devices essentially came to a stand-still in the past years.
HTH,
Gerhard