Standards

Testing & standards applied

ASTM, EN, and ISO test standards per instrument category.

ASTM F899

Stainless steel for surgical instruments

ASTM F967

Corrosion fatigue testing

ASTM A967

Chemical passivation treatments

ISO 7153-1

Materials for surgical instruments

ISO 2859

AQL sampling procedures

EN ISO 17665

Moist heat sterilisation

UDI / EUDAMED

Unique Device Identifier registration

ISO 11135

EO sterilisation