ISO 8009 Testing Laboratory

ISO 8009 Mechanical contraceptives -- Reusable natural and silicone rubber contraceptive diaphragms -- Requirements and tests

This standard was developed for use with contraceptives, mechanical, or drug eluting. It is also applied to controlled release vaginal rings for HRT, chemotherapy, or other targeted treatments.

A variety of test methods are given: dimensional checks, tensile and compressive strength tests with distortion and fatigue considerations, twisting and visual assessments, and the effect of accelerated ageing.

Our laboratory has developed equipment for the mechanical fatigue testing and for the accurate measurement of twisting.

We commonly combine this testing with condom compatibility studies and packaging validation for sterile devices.

Along with our extractables and leachables and API release studies, MET can provide complete design validation support for these products.

Our laboratory provides a full suite of mechanical studies and chemical analysis to examine a variety of drug delivery products including:

Ambulatory injection devices

Combination devices