Toxicology studies enable to assess the interactions between substances and biological systems, in order to determine possible adverse effects on health. The toxicology aims to assess the nature and impact of these effects on living organisms, through the examination of biological alterations induced.
Biochem has decades of experience, highly qualified staff, high level references, and is the right partner for achieving your goals.
Biochem has decades of experience, highly qualified staff, high level references, and is the right partner for achieving your goals. Biochem realizes the biocompatibility and toxicology tests required by various Pharmacopoeias, by the UNI EN ISO 10993, chosen according to the type of devices, their invasiveness, and the duration and type of contact with human tissue. The chemical characterization of the component materials of Medical Devices is a preliminary and essential part of the Studies of Biocompatibility, which have increasing importance for compliance with the Animal Welfare.
- Biocompatibility tests
- Chemical tests
- Eu.Ph. 3.1.1.1 Materials Based On Plasticised Poly(Vinyl Chloride) For Containers For Human Blood And Blood Components
- Eu.Ph. 3.1.1.2 Materials Based On Plasticised Poly(Vinyl Chloride) For Tubing Used In Sets For The Transfusion Of Blood And Blood Components.
- Eu.Ph 3.1.3. Polyolefines
- Eu.Ph. 3.1.6. Polypropylene for containers and closures for parenteral preparations and ophthalmic preparations
- Eu.Ph 3.1.7. Poly(ethylene – vinyl acetate) for containers and tubing for total parenteral nutrition preparations
- Eu.Ph. 3.1.6. Polipropilene per contenitori, recipienti e chiusure per preparazioni parenterali e per preparazioni oftalmiche
- Eu.Ph. 3.1.8. Silicone oil used as a lubricant
- Eu.Ph. 3.1.8. Silicone (oil)
- Eu.Ph. 3.1.9. Silicone elastomer for closures and tubing
- Eu.Ph. 3.1.10. Materials Based On Non-Plasticised Poly(Vinyl Chloride) For Containers For Non-Injectable, Aqueous Solutions
- Eu.Ph. 3.1.11. Materials Based On Non-Plasticised Poly(Vinyl Chloride) For Containers For Dry Dosage Forms for Oral Administration
- Eu.Ph. 3.1.13. Plastic additives
- Eu.Ph. 3.1.14. Materials based on plasticised poly(vinyl chloride) for containers for aqueous solutions for intravenous infusion
- Eu.Ph. 3.1.15. Polyethylene terephthalate for containers for preparations not for parenteral use
Here:
See http://www.salute.gov.it/portale/temi/p2_4.jsp?lingua=italiano&area=dispositivi-medici you can see the portal of the Italian Ministry of Health, where you can find information, updates, regulatory references and utility tools.
If you have not found the test or service of your interest please contact our Sales Department.