ISO 20749:2017
Dentistry — Pre-capsulated dental amalgam
ISO 20749:2017 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.
ISO 20749:2017 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.
ISO 20749:2017 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.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
4.1 Package and capsule contamination
4.2 Chemical composition and purity of the dental amalgam alloy
4.3 Large particles in the dental amalgam alloy powder
4.4 Loss of mass from the capsule during mixing
4.5 The yield of amalgam from the capsule
4.6 Consistency of the dental amalgam from capsule to capsule
4.7 Properties of the dental amalgam
4.7.1 Creep
4.7.2 Dimensional changes during hardening
4.7.3 Compressive strength at 1 h
4.7.4 Compressive strength at 24 h
4.8 Appearance of the mixed dental amalgam before setting
4.9 Length tolerance for the capsule
5 Sampling
6 Test methods
6.1 Package and capsule contamination
6.1.1 Principle
6.1.2 Test sample
6.1.3 Apparatus
6.1.4 Procedure
6.1.5 Expression of the results
6.1.6 Report
6.2 Chemical composition and purity of the dental amalgam alloy
6.2.1 Principle
6.2.2 Test sample
6.2.3 Apparatus
6.2.4 Procedure
6.2.5 Expression of results
6.2.6 Report
6.3 Large particles in the dental amalgam alloy powder
6.3.1 Principle
6.3.2 Test sample
6.3.3 Apparatus
6.3.4 Test procedure
6.3.5 Expression of the results
6.3.6 Report
6.4 Loss of mass from the capsule during mixing
6.4.1 Principle
6.4.2 Test sample
6.4.3 Apparatus
6.4.4 Test procedure
6.4.5 Expression of the results
6.4.6 Report
6.5 Yield of amalgam from the capsule
6.5.1 Principle
6.5.2 Test sample
6.5.3 Apparatus
6.5.4 Test procedure
6.5.5 Expression of the results
6.5.6 Report
6.6 Consistency of the dental amalgam from capsule to capsule
6.6.1 Principle
6.6.2 Test sample
6.6.3 Apparatus
6.6.4 Test-piece production
6.6.5 Microhardness measurement
6.6.6 Expression of the results
6.6.7 Report
6.7 Properties of the dental amalgam
6.7.1 Principle
6.7.2 Sample
6.7.3 Mould for the preparation of cylindrical test-pieces for determining creep, dimensional change during hardening and compressive strength
6.7.4 Preparation of cylindrical test-pieces to determine compliance with the requirements for creep, dimensional change during hardening and compressive strength
6.7.5 Determination of creep
6.7.6 Determination of dimensional change during hardening
6.7.7 Determination of compressive strength
6.8 Appearance of the mixed dental amalgam before setting
6.8.1 Principle
6.8.2 Apparatus
6.8.3 Test procedure
6.8.4 Expression of the results
6.8.5 Report
6.9 Length tolerance for the capsule
6.9.1 Principle
6.9.2 Test sample
6.9.3 Apparatus
6.9.4 Test procedure
6.9.5 Expression of the results
6.9.6 Report
7 Marking, labelling and packaging
7.1 Packaging
7.2 Marking and labelling
7.2.1 Information
7.2.2 Labelling of a package for dental mercury
7.2.3 Labelling of the outer surface of package or container used for shipping
7.3 Manufacturer’s instructions
7.3.1 General instructions
7.3.2 Precautionary notes
Bibliography
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
4.1 Package and capsule contamination
4.2 Chemical composition and purity of the dental amalgam alloy
4.3 Large particles in the dental amalgam alloy powder
4.4 Loss of mass from the capsule during mixing
4.5 The yield of amalgam from the capsule
4.6 Consistency of the dental amalgam from capsule to capsule
4.7 Properties of the dental amalgam
4.7.1 Creep
4.7.2 Dimensional changes during hardening
4.7.3 Compressive strength at 1 h
4.7.4 Compressive strength at 24 h
4.8 Appearance of the mixed dental amalgam before setting
4.9 Length tolerance for the capsule
5 Sampling
6 Test methods
6.1 Package and capsule contamination
6.1.1 Principle
6.1.2 Test sample
6.1.3 Apparatus
6.1.4 Procedure
6.1.5 Expression of the results
6.1.6 Report
6.2 Chemical composition and purity of the dental amalgam alloy
6.2.1 Principle
6.2.2 Test sample
6.2.3 Apparatus
6.2.4 Procedure
6.2.5 Expression of results
6.2.6 Report
6.3 Large particles in the dental amalgam alloy powder
6.3.1 Principle
6.3.2 Test sample
6.3.3 Apparatus
6.3.4 Test procedure
6.3.5 Expression of the results
6.3.6 Report
6.4 Loss of mass from the capsule during mixing
6.4.1 Principle
6.4.2 Test sample
6.4.3 Apparatus
6.4.4 Test procedure
6.4.5 Expression of the results
6.4.6 Report
6.5 Yield of amalgam from the capsule
6.5.1 Principle
6.5.2 Test sample
6.5.3 Apparatus
6.5.4 Test procedure
6.5.5 Expression of the results
6.5.6 Report
6.6 Consistency of the dental amalgam from capsule to capsule
6.6.1 Principle
6.6.2 Test sample
6.6.3 Apparatus
6.6.4 Test-piece production
6.6.5 Microhardness measurement
6.6.6 Expression of the results
6.6.7 Report
6.7 Properties of the dental amalgam
6.7.1 Principle
6.7.2 Sample
6.7.3 Mould for the preparation of cylindrical test-pieces for determining creep, dimensional change during hardening and compressive strength
6.7.4 Preparation of cylindrical test-pieces to determine compliance with the requirements for creep, dimensional change during hardening and compressive strength
6.7.5 Determination of creep
6.7.6 Determination of dimensional change during hardening
6.7.7 Determination of compressive strength
6.8 Appearance of the mixed dental amalgam before setting
6.8.1 Principle
6.8.2 Apparatus
6.8.3 Test procedure
6.8.4 Expression of the results
6.8.5 Report
6.9 Length tolerance for the capsule
6.9.1 Principle
6.9.2 Test sample
6.9.3 Apparatus
6.9.4 Test procedure
6.9.5 Expression of the results
6.9.6 Report
7 Marking, labelling and packaging
7.1 Packaging
7.2 Marking and labelling
7.2.1 Information
7.2.2 Labelling of a package for dental mercury
7.2.3 Labelling of the outer surface of package or container used for shipping
7.3 Manufacturer’s instructions
7.3.1 General instructions
7.3.2 Precautionary notes
Bibliography