International Product Standards: EN 455 1-4, EN ISO 374 1-5:2016, EN ISO 21420:2019, ASTM D3577, ASTM D6978, ASTM F739, ISO 10993, AS/NZS 4179, ISO 10282, JIS T9107
Quality / Environment Standards: ISO 9001, ISO 13485:2016, ISO 14001
Compliance to Regulations: EU MDR 2017/745, USA 510k, MDSAP
Notified Body / Test Laboratories: DEKRA, SATRA, ARDL, BSI
PPE Compliance / Type: PPE Regulation (EU) 2016/425, Type B
Biological Evaluation: EN 10993, Primary Skin Irritation Test, Dermal Sensitization Assay, Cytotoxicity Test
Additional Tests: Viral Penetration PPE Compliance (ASTM F1671), Chemotherapy Drugs (ASTM D6978), Chemical Residue