BS ISO 20749:2017 Dentistry – Pre-capsulated dental amalgam
BS ISO 20749:2017 pdf free.Dentistry – Pre-capsulated dental amalgam.
This document specifies the requirements and test methods for dental amalgam products supplied to the user in capsules, pre-dosed with dental amalgam alloy and dental mercury in quantities suitable for the creation of a single dental restoration.
This document specifies the requirements and test methods for dental amalgam alloys that are suitable for the preparation of dental amalgam and the capsule, together with the requirements and test methods for that dental amalgam and the requirements for packaging and marking.
This document is not applicable to dental amalgam alloys supplied as a free-flowing powder in bulk quantities or as powder compressed into tablets, or to dental mercury supplied in sachets or bulk quantities.
This document is not applicable to other metallic materials in which an alloy powder reacts with an alloy that is liquid at ambient temperature to produce a solid metallic material intended for dental restoration.
Specific qualitative and quantitative test methods for demonstrating freedom from unacceptable biological hazard are not included in this document. For the assessment of possible biological hazards, reference can be made to ISO 10993-1 and ISO 7405.
The scope of this document is restricted to dental amalgam products marketed in pre-capsulated form alone. Other products intended for use in the production of dental amalgam restorations (dental amalgam alloy as a free-flowing powder supplied in bulk masses, dental amalgam alloy powder supplied as compressed tablets and dental mercury sachets) are within the scope of ISO 24234.
2 Normative references
The following documents are referred to in the text in such a way that some or all ot their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
3 Terms and definitions
For the purposes of this document, the terms and definitions given in Iso 1942 and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— IEC Electropedia: available at http://www.electropedia.orgJ
— ISO Online browsing platform: available at http://www.iso.org/obp
4 Requirements
4.1 Package and capsule contamination
The interior of the packaging container and the outer surface of the capsules shall be free of both dental mercury and dental amalgam alloy powder contamination when tested in accordance with 6.1.
4.2 Chemical composition and purity of the dental amalgam alloy
The manufacturer shall declare every element that is present intentionally and in a concentration greater than or equal to 0,1 % (by mass). All alloying elements present in concentrations greater than 0,5 % (by mass) shall be given by name with percentage by mass values rounded to the nearest whole percentage point. Alloying elements that are present in concentrations between 0,1 % and 0,5 % (by mass) shall be named without a percentage value.
Determine the chemical composition in accordance with Z.
The chemical composition shall comply with Table 1.
The total for elements that are not declared by the manufacturer as alloying elements shall not exceed
0,1 % (by mass).
4.3 Large particles in the dental amalgam alloy powder
When compliance with this requirement is determined in accordance with 3. the proportion of the dental amalgam alloy powder that occurs as particles that have a size greater than 150 im shall not exceed 0,1 % (by mass).
4.4 Loss of mass from the capsule during mixing
When compliance with this requirement is determined in accordance with 6A. the average loss in mass of dental mercury and dental amalgam alloy powder from 15 capsules (during mixing in accordance with the manufacturer’s instructions) shall not exceed 0,5 mg.
Also, the loss from any one capsule shall not exceed 1 mg.
4.5 The yield of amalgam from the capsule
When compliance with this requirement is determined in accordance with 6.5. the average mass of the pellet of dental amalgam obtained from a capsule (for a sample of 15 capsules) shall not be less than 95,0 % of the sum of the manufacturer’s stated masses for dental mercury and dental amalgam alloy in the capsule.
4.7 Properties of the dental amalgam
4.7.1 Creep When compliance with this requirement is determined in accordance with 61 the results for either three out of three or four out of five test-pieces shall meet the requirement in Table 2.
4.7.2 Dimensional changes during hardening
When compliance with this requirement is determined in accordance with 61.. the results for at least four out of five test-pieces shall meet the requirement in Table 2.
4.7.3 Compressive strength at 1 h
When compliance with this requirement is determined in accordance with 61.. the results for at least four out of five test-pieces or eight out of 10 test-pieces shall meet the requirement in Table.2.
4.7.4 Compressive strength at 24 h
When compliance with this requirement is determined in accordance with 61. the results for at least four out of five test-pieces or eight out of 10 test-pieces shall meet the requirement in Table 2.
4.8 Appearance of the mixed dental amalgam before setting
When compliance with this requirement is determined in accordance with 6B when the dental amalgam alloy and dental mercury are mixed according to the manufacturers instructions, the dental amalgam shall form a coherent plastic mass with a shiny surface before packing and remain a coherent plastic mass after packing.
4.9 Length tolerance for the capsule
When compliance with this requirement is determined in accordance with 6.9. the overall length of the activated capsule shall be within ±1 mm of the length specified by the manufacturer. All 10 capsules in the sample tested shall meet the requirement.
5 Sampling
Procure containers of capsules of the same lot in packages that have been produced for retail.
NOTE The number of capsules required depends on the masses of dental amalgam alloy and dental mercury
in each.
6 Test methods
6.1 Package and capsule contamination
6.1.1 Principle
Any loss of either component from a capsule during transit is a concern. Such a loss can be detected by visual examination using low power magnification.
6.1.2 Test sample
Test all containers holding the capsules from the sample procured for testing, as well as 25 capsules selected at random from the same sample.
6.1.3 Apparatus
Stereomicroscope, xIO magnification.
6.1.4 Procedure
Using the stereomicroscope, inspect the interior surfaces of all the containers holding capsules and the external surfaces of the 25 capsules. Examine these for traces of dental amalgam alloy powder and visible beads of dental mercury.
6.1.5 Expression of the results Record the observations.BS ISO 20749 pdf free download.BS ISO 20749:2017 Dentistry – Pre-capsulated dental amalgam