BS EN ISO 6874:2015 pdf free.Dentistry-Polymer-based pit and fissure sealants.
BS EN ISO 6874 specifies requirements and Lest methods for polymer-based materials intended for sealing pits and fissures in teeth.
This International Standard covers both self-curing and external-energy-activated materials.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 1942, Dentistry — Vocabulary
ISO 8601, Data elements and interchange formats — Information interchange — Representation of
dates and times
3 Classification
For the purposes of this International Standard, polymer-based pit and fissure sealants are classified, according to the method of curing, as follows:
Class 1:Materials whose setting is effected by mixing an initiator and activator (“self-curing” materials). Class 2:Materials whose setting is effected by the application of energy from an external source, such as
visible light (‘external-energy-activated” materials).
4 Requirements
4.1 Biocompatibility
See the Introduction for guidance on biocompatibility, ISO 7405 and ISO 10993-1.
4,2 Physical properties
4.2.1 Working time, Class 1 sealant
The working time for Class 1 sealants, determined in accordance with ,4, shall not be less than 40 5.
4.2.2 Setting time, Class 1 sealant
The setting time for Class 1 sealants, determined in accordance with 6S, shall not be greater than 5 mm.
5 Sampling
The test sample shall consist of a retail package, or packages, from the same batch containing sufficient
material (a minimum of 20 g) to carry out the specified tests and repeat tests, if necessary.
6 Test methods
6.1 Inspection
inspect visually to check that requirements specilied in (iause 2 have been met.
6.2 Test conditions
Unless specified otherwise by the manufacturer, prepare and test all specimens at (23 ± 2) °C. Control the relative humidity to ensure that it remains greater than 30 % at all times. lithe material was refrigerated for storage, allow it to attain (23 ± 2) °C before use.
For the preparation of class 2 materials, reference shall be made to the manufacturer’s instructions [see Z3 e) and g)j that state the external energy source or sources recommended for the materials to be tested. Care shall be taken to ensure that the source is in a satisfactory operating condition.
NOTE See also ISO 10650 (all parts).
6.3 Preparation of test specimens
Mix or otherwise prepare the material in accordance with the manufacturer’s instructions and the test conditions specified in Z.
6.4 Working time, Class 1 sealant
6.4.1 Apparatus Thermometry apparatus, as shown in Figure 1.
The apparatus consists of a piece of polyethylene (or similar material) tubing, A, located on a block of polyamide or similar material, B, which has a hole into which is inserted a stainless steel tube, C, containing a stabilized thermocouple D.
The polyethylene tube A is 6 mm long, 4 mm in internal diameter and has a wall thickness of 1 mm. The locating part of block B is 4mm in diameter and 2 mm high. When assembled, the two components form a specimen well 4 mm high x 4 mm in diameter. In order to facilitate removal of the specimen after testing, the thermocouple D has a conical tip that protrudes 1 mm into the base of the specimen well. The tolerances on the above-mentioned dimensions are ± 0,1 mm.BS EN ISO 6874 pdf free download.