The biological safety of medical devices is assessed using the international standard, BS EN ISO 10993. 

SMTL have over 15 years experience in  testing medical devices to EN ISO 10993 - Part 5.

During this time a large number of different types of products have been examined, including  catheters, gloves, dressings and wheelchair material.

Part 5 of the standard describes the test methods which are to be used to assess the in vitro cytotoxicity of medical devices. These methods specify the incubation of cultured cells either directly or through diffusion with extracts produced from a device or in contact with the device.

SMTL offer the extraction method followed by examination of the cells microscopically using cytochemical staining to assess changes

Medical device manufacturers must comply with the safety requirements contained in the Medical Devices Directive to minimise the risks to users and patients.  It is important that manufacturers have their products evaluated using appropriate tests that satisfy the requirements for all countries in which they are to be marketed.

Standards

BS EN ISO 10993-5: Biological Evaluation of Medical Devices - Part 5: Tests for in vitro cytotoxicity

If you wish to commission testing, then contact the SMTL:

Surgical Materials Testing Laboratory, Princess of Wales Hospital, Coity Road, Bridgend, UK, CF31 1RQ.

Tel: +44 (0) 1656 752820
Email: biological@smtl.co.uk