BS ISO 24234:2021

What is ISO 24234 about?  

ISO 24234 addresses dentistry that 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. 

ISO 24234 does not apply to dental amalgam alloy powder and dental mercury supplied in a pre-capsulated form. 

ISO 24234 does not apply to dental amalgam alloy powder and dental mercury supplied in a pre-capsulated form. 

ISO 24234 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. 

ISO 24234 does not apply 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 

Note: Two of the requirements apply only to dental mercury (as supplied). All of the other requirements applicable to the dental amalgam alloy (as supplied) and dental amalgam. 

Who is ISO 24234 for? 

ISO 24234 on dentistry is useful for-  

• Manufacturers of dental amalgam 
• Medical laboratories 
• Healthcare centres 

Why should you use ISO 24234? 

Dental amalgam is a dental filling material used to fill cavities caused by tooth decay. Dental amalgamation is a mixture of metals, consisting of liquid (elemental) mercury and a powdered alloy composed of silver, tin, and copper. Approximately half (50%) of dental amalgam is elemental mercury by weight. 

ISO 24234 guidelines will help you with requirements, sampling, reports, marking, and labeling which is important for the manufacturing of Dental amalgam that will improve the quality. It also helps ensure the patient’s health and safety. 

What’s changed since the last update? 

BS ISO 24234:2021 supersedes ISO 24234:2015, which has been withdrawn. BS ISO 24234:2021 has some technical changes with respect to ISO 24234:2015, these include: 

• Pre-capsulated dental amalgam products have been removed from the scope of this document 
• A requirement for corrosion resistance has been added 
• In previous editions of this document, the presence of a limited number of foreign body particles in the dental amalgam alloy powder was permitted. Now, as a requirement, foreign body particles are not permitted to be present in the dental amalgam alloy powder 
• The roughness parameter used to specify the finish required on working surfaces of test-piece moulds has been changed from R k to R a. 
• An instruction to lightly abrade the ends of the cylindrical test-pieces, if required for removing flash, has been deleted and the requirement for early compression strength has been altered. Measurement of the value is made at 2 h and not at 1 h