ASTM D6978
ASTM D6978 is the central test standard for gloves used in handling cytotoxic drugs and has become the international reference for chemotherapy gloves.
Differences from EN 16523-1:
- Test temperature 35 °C instead of 23 °C, reflecting skin temperature and accelerating permeation realistically
- Lower breakthrough threshold, so smaller quantities of substance already count as breakthrough
- A defined panel of typical cytotoxic drugs
Reporting: breakthrough time is stated per drug.
Regulatory context: in the EU chemotherapy gloves are dually regulated. As medical devices they fall under MDR and EN 455; as PPE Category III under Regulation (EU) 2016/425 and EN ISO 374-1. ASTM D6978 supplements this evidence with the cytotoxic-specific permeation test.
Frequently asked questions
Why is ASTM D6978 stricter than EN 16523-1?
Because it tests at 35 °C rather than 23 °C, which accelerates permeation realistically, and because it applies a lower breakthrough threshold. It also tests with actual cytotoxic drugs rather than general industrial chemicals.
Which drugs are tested under ASTM D6978?
A defined panel of typical cytotoxic drugs.
Does ASTM D6978 replace CE marking?
No. ASTM D6978 is a US test standard carrying no EU presumption of conformity. In the EU, MDR with EN 455 and the PPE Regulation with EN ISO 374-1 remain decisive; ASTM D6978 adds the cytotoxic-specific evidence.