Los Deline® Safety
Manufacturing
For Los Deline® manufacturing, company-manufacturer BIOTRH s.r.o. uses manufacturing facilities of BIOMEDICA spol. s.r.o. pharmaceutical company, located in an innovative chemical, pharmaceutical and engineering zone (Czech Republic).
The product is manufactured under the strictest sterilization and control methods. Strict adherence to sterilization, packaging, and safety tests of product before release is conducted by independent labs and manufacturer appointed personnel.
Our company’s comprehensive safety philosophy is implemented throughout the process chain from raw material selection to actual manufacture, storage and final transport to the customer.
Our products are manufactured in state-of-the art facilities and subjected to the most stringent of quality and safety controls at all stages of production as well as being fully certified according to all relevant international standards and regulations.
Standards and certification
Los Deline® is manufactured according to the highest quality standards of the EU.
The Sterile Hydrophilic Gel for Endoprosthetics of Human Soft Tissues Los Deline® are covered by certificates:
EC CERTIFICATE
According to Annex II of the Directive 93/42/EEC on Medical Devices Full Quality Assurance System
no.: 2195-MED-1820101
EC DESIGN EXAMINATION CERTIFICATE
no.: 2195-MED-1820101-D01
ISO 13485:2003 (MEDICAL DEVICES QUALITY MANAGMENT SYSTEM)
no.: 31820101
Biocompatibility
The product Los Deline® conforms to ISO 10993:2009 Biological evaluation of medical devices. This standard defines devices in terms of their invasiveness and duration of patient contact. This means that the biological safety of various categories of possible toxicological effects was considered. Material is biologically compatible by not eliciting a local or systemic response from a living system or tissue.
List of conducted device safety/biocompatibility evaluation:
• Cytotoxicity studies (ISO 10993-5)
• Sensitization studies (ISO 10993-10)
• Irritation studies (ISO 10993-10)
• Systemic toxicity studies (ISO 10993-11)
• Genotoxicity/Mutagenicity studies (ISO 10993-3)
• Implantation studies (ISO 10993-6)