BS EN ISO 13897:2018,Dentistry – Dental amalgam reusable mixing-capsules.BS EN ISO 13897:2018 pdf free download here.
BS EN ISO 13897:2018 specifies the requirements for reusable mixing-capsules intended to contain dental amalgam alloy powder and dental mercury when these are mixed to produce dental amalgam, and the test methods used to determine conformity to these requirements.
In order to produce dental amalgam, an electrically-powered mixing machine, as described in ISO 7488 is used for mixing dental amalgam alloy powder with dental mercury. In addition, a removable mixing- capsule is used to contain the dental amalgam alloy and the dental mercury during the mixing process.
2 Normative references
ISO 1942 Dentistry-Vocabulary;
ISO 7488, Dentistry-Mixing machines for dental amalgam;
ISO 24234: 2015, Dentistry-Dental amalgam;
Length tolerance
The overall length of the mixing-capsule shall be within +1 mm of the length specified 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 length tolerance.
Retention of dental amalgam in the mixing-capsule
The retention of dental amalgam in the mixing-capsule after the dental amalgam pellet has been removed shall not exceed 1% of the combined masses of dental amalgam alloy and dental mercury inserted before mixing.
Testing shall be carried out in accordance with 6.3.
Five out of five, or nine out of 10, mixing-capsules in the sample under test shall meet the requirement for retention of dental amalgam in the mixing capsule.