What is this standard about?
This is part six in a series of international standards on the biological evaluation of medical devices. This part specifies tests for assessing local effects after implantation of biomaterials intended for use in medical devices.
Who is this standard for?
- Medical device manufacturers
- Laboratories and testing facilities
- Regulators
Why should you use this standard?
This part of ISO 10993 applies to materials that are:
- Solid and non-absorbable
- Non-solid, such as porous materials, liquids, gels, pastes and particulates
- Degradable and /or absorbable, which may be solid or non-solid
The objective of the tests is to characterize the history and evolution of the tissue response after implementation of a medical device/biomaterial including final integration or absorption/degradation of the material.
It can also be applied to medical devices that are intended to be used topically in clinical indications where the surface or lining might have been breached in order to evaluate local tissue responses.
This standard also supports essential requirements in two European Medical Devices Directives: 93/42/EEC and 90/385/EEC.
NOTE: This part of ISO 10993 does not deal with systemic toxicity, carcinogenicity, teratogenicity or mutagenicity. However, the long term implantation studies intended for evaluation of local biological effects might provide insight into some of these properties.
What’s changed since the last update?
This standard was revised to make it compatible with medical devices that are implanted in the central nervous system or those making contact with peripheral nerves. This use of medical devices is rising because of the increasing use of neuro-stimulation systems to treat the symptoms of Parkinson’s Disease. This revision contains test protocols and guidelines that are specifically designed to fit this purpose.