BS ISO 24234 pdf free download
BS ISO 24234-2021 pdf free download.Dentistry一Dental amalgam.
This document specifies the requirements and test methods for dental amalgam alloy powder and dental mercury that are suitable for the preparation of dental amalgam together with the requirements and test methods for that dental amalgam and the requirements for packaging and marking.
NOTE Two of the requirements apply only to dental mercury (as supplied). All of the other requirements apply to the dental amalgam alloy (as supplied) and dental amalgam.
This document is not applicable to dental amalgam alloy powder and dental mercury supplied in a precapsulated form.
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.
This document applies to products used to make dental amalgam restorations, supplied to the user in the following forms: dental amalgam alloy as a fine free flowing powder, or as a fine powder compacted into tablets and dental mercury in dental mercury sachets (sometimes referred to as dental mercury pillows). The mass of dental mercury in these sachets is limited to the amount required to make a small to medium-sized restoration in a single tooth.
This document is not applicable to dental mercury that is supplied in a primary container in an undivided mass that exceeds the amount suitable for a small to medium-sized restoration.
2 Normative references
The following documents are referred to in the text in such a way that some or all of 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.
ISO 286-2. Geometrical product specifications (GPS) — ISO code system for tolerances on linear sizes — Part 2: Tables of standard tolerance classes and limit deviations for holes and shafts
ISO 1942. Dentistry — Vocabulary
ISO 3310-1. Test sieves — Technical requirements and testing — Part 1: Test sieves of metal wire cloth
ISO 3864-2, Graphical symbols — Safety colours and safety signs — Part 2: Design principles for product
safety labels
L5.OA27. Geometrical Product Specifications (GPS) — Surface texture: Profile method — Terms, definitions and surface texture parameters
ISO 7488. Dentistry — Mixing machines for dental amalgam
ISO 1389Z Dentistry — Dental amalgam reusable mixing-capsules
ISO 15223-1:2016. Medical devices — Symbols to be used with medical device labels, labelling and
information to be supplied — Part 1: General requirements
ISO 23325., Dentistry — Corrosion resistance of dental amalgam
UN Recommendations on the Transport of Dangerous Goods, Model Regulations. United Nations, New York and Geneva, 21St Edition, 2019, elSBN 978-92-1-004112-6
ISOURCE: ISO/TS 20746:2016, 3.5, modified — ‘dental amalgam alloy” has been replaced with dental amalgam alloy powder” in the definition and the term “dental mercury pillow” has been added.
3.6 mixing machine for dental amalgam
DEPRECATED: amalgamator
electrically powered mixing machine that operates using an oscillating action for mixing dental amalgam alloy (3d) and dental mercury (32) (in a capsule) to produce a dental amalgam
ISOURCE: ISO/TS 17988: 2020, 3.121
4 Requirements
4.1 Chemical composition and purity of the dental amalgam alloy
The manufacturer shall declare every element that is present in a concentration greater than, or equal to a mass fraction of 0,1 %. All alloying elements present in concentrations greater than a mass fraction of 0,5 % shall be given by name with mass fraction values rounded to the nearest whole percentage point. Alloying elements that are present in concentrations between a mass fraction of 0,1 % and 0,5 % shall be named without a percentage value.
Test in accordance with £1.
The chemical composition shall comply with Table 1.
The total mass fraction for other elements present in concentrations greater than a mass fraction of 0,01 % but below a mass fraction of 0,1 % that are not declared as alloying elements shall not exceed a mass fraction of 0.1 %.BS ISO 24234 pdf download.
