Quality

quality

IBI pays extreme attention to safety and quality of its Medical Devices.

The company Quality System is certified ISO 13485:2016.
SmartBone® and SwissBone® are CE marked according to 93/42/EEC Medical Device Directive and its following amendments and modifications:

  • SmartBone® and SwissBone® are bone substitutes certified for dental indications;
  • SmartBone® ORTHO is a bone substitutes certified for orthopaedics indications.

Certification

Quality Managment System – ISO 13485:2016 & EN ISO 13485:2016

Animal Origin (BSE/TSE)

The bovine bones used to produce SmartBone® and SwissBone® come from certified Bovine spongiform encephalopathy (BSE) free bovine breedings.

Cleaning process

The bovine bone washing and cleaning is performed at low-temperature through a multi-step chemical process: the material is hence not ceramic-like, but a natural material conserving the optimal mechanical properties of a bovine-originated mineral structure.

Moreover, the process inactivates pathogens and removes the unwanted materials, such as cells, antigens and viruses.

Reinforcement treatment

  • The reinforcement treatment is made by combining bioresorbable polymers (aliphatic polyesters) and collagen fragments (gelatin-derived); the process consists of a thin-film deposition of the two materials on the surface of trabecular bovine bone matrix;
  • The polymer is a GMP grade block-copolymer of L-lactide and ε-caprolactone. It is primarily used for medical devices (i.e. surgical suture) and it is suitable for all commonly used polymer processing techniques;
  • The collagen fragments come from MedellaPro, producted by Gelita AG.

Sterilization

The Medical Device is subjected to different sterilization processes depending on the type of the packaging:

  • ethylene oxide (EtO) for devices packaged into pouches;
  • β-ray (E-beam) irradiation for devices packaged into vials.

Both methods are safe and reliable and duly validated.

Contacts

IBI S.A.
Industrie Biomediche Insubri S.A.
via Cantonale 67, CH-6805 Mezzovico-Vira, Switzerland
t. +41 91 93.06.640
f. +41 91 220.70.00