BS EN ISO 22803:2005 – Dentistry — Membrane materials for guided tissue regeneration in oral and maxillofacial surgery — Contents of a technical file

4 General description Membrane materials are widely used in periodontology and oral and maxillofacial surgery, and have characteristics which are unique to these applications, for example:
a) placement in contact with teeth and their supporting tissues;
b) prevention of oral mucosal epithelial migration into surgically treated defects;
c) predictable loss of structural integrity and mechanical properties over time in oral sites into which dental implants are to be subsequently placed;
d) known behaviour of the material should it become inadvertently exposed to the oral or paranasal cavities subsequent to placement;
e) augmentation of the volume or dimension of bone for enhanced stabilization of dentures or for placement of dental implants. The development of membrane materials shall be considered with regard to the properties required for the intended purpose, taking into account the effects of manufacture, handling, sterilization and storage. Possible reactions (intended or not) of membrane materials with human tissues and body fluids, other materials, other implants, substances, gases, radiation and electromagnetic fields shall be considered. Membrane materials for periodontal tissue reconstruction in oral and maxillofacial surgery are used as either a barrier or a covering of packing materials. During their use, these materials can induce an acute inflammatory reaction, which must be evaluated by specific tests.
5 Contents of a technical file
5.1 General
The contents of a technical file shall include the following information about the membrane material:
a) details of its chemical composition;
b) its intended performance;
c) its preclinical and clinical evaluations;
d) details of its manufacture, sterilization and packaging;
e) certain other items of information necessary for the user.
5.2 Chemical composition
Refer to ISO 1 0993-1 3, ISO 1 0993-1 4, ISO 1 0993-1 5 and ISO 1 0993-1 8 for guidance. All polymer characterization shall be completed after recommended sterilization procedures have been applied.
5.3 Intended performance
The intended performance of a membrane material shall be described and documented by addressing the following:
— general description of the product;
— functional characteristics: resorbable, partially resorbable or non-resorbable;
— typical intended applications: simple barrier (in this case give physical and mechanical characteristics, including deformability);
— completely submersed or not during use;
— intended conditions of use;
— whether the device is intended to be used with fixation;
— included physical additives (e.g. titanium);
— included chemical additives (e.g. mineral salts);
— included material degradation when undergoing multiple cycles of reprocessing;
— reference to published standards to which the device conforms, with particular regard to safety.
Account should be taken of
— published standards,
— published clinical and scientific literature,
— validated test results.
BS EN ISO 22803-2005