BS EN ISO 13897:2018 pdf free.Dentistry – Dental amalgam reusablemixing-capsules (ISo 13897:2018).
1.Scope:This document specifies the requirements for reusable mixing-capsules intended to contain dentalamalgam alloy powder and dental mercury when these are mixed to produce dental amalgam, and thetest methods used to determine conformity to these requirements.
NOTE IS0 7488 specifies requirements for mixing machines. The requirements for mixing-capsule are notdealt with in ISO 7488, although the mixing-capsule is an essential part of the mixing machine.
2.Normative references:The following documents are referred to in the text in such a way that some or all of their contentconstitute requirements of this document. For dated references only the edition cited applies.Forundated 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.
3.1.dental amalgam alloy:alloy in fine particles, composed mainly of silver,tin and copper, which when mixed with dental mercuryproduces a dental amalgam [SOURCE:ISO 20749:2017,3.1
3.2.dental mercury:mercury supplied for use in the preparation of dental amalgam[SOURCE: ISO 20749:2017,3.2]
4.Length tolerance:The overall length of the mixing-capsule shall be within :1 mm of the length specified by themanufacturer.Testing shall be carried out in accordance with 6.1.All 10 capsules in the sample under test shall meet the requirement for length tolerance.4.1.2 Diameter tolerance
The maximum external diameter of the mixing-capsule shall be within ±0,5 mm of the diameterspecified by the manufacturer.
Testing shall be carried out in accordance with 6.1.All 10 capsules in the sample under test shall meet the requirement for diameter tolerance.4.2 Loss of mass from the mixing-capsule during mixing.The loss in mass from the mixing-capsule during mixing shall not exceed 0,5 mg.Testing shall be carriedout in accordance with 6.2.Five out of five, or nine out of 10, mixing-capsules in the sample under test shall meet the requirementfor loss of mass from the mixing-capsule during mixing. Retention of dental amalgam in the mixing-capsule
The retention of dental amalgam in the mixing-capsule after the dental amalgam pellet has beenremoved shall not exceed 1 % of the combined masses of dental amalgam alloy and dental mercuryinserted before mixing. BS EN ISO 13897 pdf download.