OzVet Sutures are manufactured in accordance with manufacturing and quality standards CE 1293, ISO 9001:2008, and ISO 13485:2003. In technical consultation with H&A consultants, Williamsburg, VA 23188, USA. Meets Class 10,000 cleanliness standard of US FED 209E (i.e. not more than 10,000 particles of size 0.5 microns per cubic feet of air) equivalent to ISO Class 7. This includes individual class 10,000 clean rooms for storage (critical components), preparation (sutures), assembly, packaging and sterilisation. All sutures are 100% EtO sterilised without residual EtO, validated as per international quality systems in sterilisation.