YY/T 0268-2001Dentistry - Preclinical evaluation of biocompatibility of medical devices used in dentistry - Part 1: Evaluation and selection of test methods (English PDF)

3.5 Negative-control material; reference material

Material or substance which, when tested by the procedure described, demonstrates the suitability of the procedure to yield a reproducible, appropriate negative, nonreactive or background response in the test system.

4.1 Classification by nature of contact

For the purposes of this Standard, the classification of medical devices used in dentistry is derived from GB/T 16886.1 – ISO 10993-1. If a device or material can be placed in more than one category, the more rigorous testing requirements shall apply. With multiple exposures the decision into which category a device is placed shall take into account the potential cumulative effect, bearing in mind the period of time over which these exposures occur.

4.1.1 Noncontact devices

These devices do not contact the patient’s body directly or indirectly, and are not included in

GB/T 16886 - ISO 10993.

4.1.2 Surface-contacting devices

These devices include those that contact the surface of intake or breached skin, the surface of intact or breached oral mucosa, and those that contact the external surfaces of dental hard tissue, including enamel, dentine and cementum.

NOTE: Dentine and cementum are considered as surfaces; e.g. after gingival recession.

4.1.3 External communicating devices

These devices include dental devices that penetrate and are in contact with oral mucosa, dental hard tissues, dental pulp tissue or bone, or any combination of these, and are exposed to the oral environment.

4.1.4 Implant devices

These devices include dental devices and implants that are partially or fully embedded within the soft tissue, bone or pulpodentinal tissue or combination of these tissues of the tooth, or any combination of these, and are not exposed to the oral environment.

4.2 Classification by duration of contact

For the purposes of this Standard, medical devices used in dentistry are classified by duration of contact as described in GB/T 16886.1 - ISO 10993-1, i.e.: