ASTM International
ASTM International (formerly American Society for Testing and Materials) is one of the world's largest voluntary standards organisations, headquartered in West Conshohocken, Pennsylvania, USA.
Relevant ASTM standards for protective gloves:
- ASTM D3578: Standard Specification for Rubber Examination Gloves (latex)
- ASTM D6319: Standard Specification for Nitrile Examination Gloves
- ASTM D5250: Standard Specification for Poly(vinyl chloride) Gloves for Medical Application
- ASTM D3577: Standard Specification for Rubber Surgical Gloves
- ASTM F739: Chemical Permeation Testing (comparable to EN 16523-1)
ASTM vs. EN standards:
- ASTM standards are aligned with the US market and FDA requirements
- EN standards are aligned with the EU market and MDR/PPE Regulation requirements
- AQL limits, test methods, and measured values may differ
- A product complying with EN 455 does not automatically comply with ASTM D6319, and vice versa
For export to the USA, manufacturers typically need FDA clearance and ASTM conformity. ASTM International is not a regulatory authority.
Frequently asked questions
Are ASTM standards recognised in Europe?
ASTM standards carry no presumption of conformity in the EU. For the EU market, EN standards apply (harmonised under MDR or PPE Regulation). For the US market, ASTM standards and FDA requirements apply. A product can comply with both sets of standards.
What is the difference between ASTM and ISO?
ISO is the international standardisation organisation (global). ASTM is a US standardisation body. Many ASTM standards have ISO equivalents, but test methods and limits may differ. European EN standards often adopt ISO standards (EN ISO).