Surgical sutures for veterinary use must conform to the European Pharmacopoeia (EP) on « Surgical sutures for veterinary use » when being used in Europe.
These norms define the requirements of quality of sterile surgical sutures in means of:
- length
- diameter
- minimal tensile strength (sutures resistance to a single knot)
- sterility
- colouring (if the case arises)
- conservation
- labelling
- needle resistance (for set sutures)
In addition, with regards to absorbable sutures, manufacturers also carry out tests of absorption in vitro for each batch to be able to guarantee the regularity of the suture’s absorption following the own characteristics of absorption of each type of absorbable suture.
A representative sample of each product batch is therefore tested by the manufacturer conforming to the demands of the European pharmacopoeia, and if it meets the requirements, it is released. A certificate of conformity for the batch is then given to prove that required tests were carried out and that the product is ready for use.
As well as these norms there are other norms: « Good Manufacturing Practices » which govern the procedures of manufacturing and must be respected by the producers of surgical sutures at each stage of fabrication; therefore guaranteeing a good quality of finished products. In order for the manufacturers to produce and commercialize their products, they have to respect the norms and be registered by the sanitary authorities of their country. Lastly, supplementary norms exist in each country which may add to European norms, demanding for example, additional controls. In our case, each type of suture is recorded at the Belgian Federal Service of Public Health and each batch is re-controlled at a registered Belgian laboratory before being released by Sprl Docteur Michel FRERE.
