ISO 20749-2023 PDF

Full title and description

ISO 20749:2023 — Dentistry — Pre-capsulated dental amalgam. Specifies requirements and test methods for dental amalgam supplied to the user in pre-dosed capsules (alloy powder and mercury) and sets requirements for the capsule, packaging and marking for products intended for a single dental restoration.

Abstract

This International Standard defines the requirements and test methods applicable to pre‑capsulated dental amalgam products (capsules containing dental amalgam alloy powder and dental mercury in quantities suitable for a single restoration). It covers the capsule design and performance, physical and chemical test methods, and requirements for packaging and labelling. The document is limited to amalgam marketed exclusively in pre‑capsulated form; other forms of amalgam alloy and mercury supply (bulk powders, compressed tablets, mercury sachets) are addressed in ISO 24234.

General information

• Status: Published (current)
• Publication date: 30 June 2023
• Publisher: International Organization for Standardization (ISO)
• ICS / categories: 11.060.10 (Dental materials)
• Edition / version: Edition 2 (2023)
• Number of pages: 35

Scope

Applies to dental amalgam products supplied in single‑use pre‑capsulated form. Establishes requirements and test methods for the composition, capsule integrity and performance, setting characteristics and dimensional behaviour, and for packaging, labelling and instructions for use. Excludes other metallic restorative materials and amalgam delivered in non‑capsulated forms (see ISO 24234 for those products).

Key topics and requirements

• Definition of pre‑capsulated dental amalgam and classification of capsule types.
• Requirements for alloy powder and mercury dosing (quantities suitable for single restorations).
• Capsule construction, dimensional tolerances and mechanical integrity (leakage, rupture resistance).
• Physical and chemical test methods (setting time, compressive strength, dimensional change, corrosion resistance and surface appearance).
• Limits and test procedures related to mercury content and handling safety.
• Packaging, labelling and marking requirements, including batch identification and expiry information.
• Instructions for use and safety information for clinicians and handlers.
• Acceptance and sampling criteria for production and quality control testing.

Typical use and users

Used by dental manufacturers (product development and quality assurance), test laboratories, regulatory bodies, procurement specialists, dental clinics and dental educators. Enables manufacturers to design and validate pre‑capsulated amalgam products and helps purchasers and regulators verify conformity and safety for clinical use.

Related standards

Closely related standards include ISO 24234 (other forms of dental amalgam/alloy supply) and other ISO dentistry standards addressing dental materials and testing (for example standards on metallic dental materials and dental test methods). It replaces the previous edition ISO 20749:2017.

Keywords

dental amalgam, pre‑capsulated, capsule, dental materials, mercury, alloy powder, test methods, packaging, labelling, dental restoration

FAQ

Q: What is this standard?

A: ISO 20749:2023 is an International Standard specifying requirements and test methods for pre‑capsulated dental amalgam products (single‑use capsules containing alloy powder and mercury).

Q: What does it cover?

A: It covers composition and dosing for pre‑capsulated amalgam, capsule design and integrity, relevant physical and chemical tests (setting, strength, dimensional change, corrosion), and packaging, labelling and instructions for use. It is limited to amalgam sold in pre‑capsulated form.

Q: Who typically uses it?

A: Dental product manufacturers, quality and regulatory teams, testing laboratories, dental clinics, procurement officers and standards committees use it to design, test, procure and regulate pre‑capsulated amalgam products.

Q: Is it current or superseded?

A: It is current. ISO 20749:2023 (published 30 June 2023) is the second edition and replaces ISO 20749:2017.

Q: Is it part of a series?

A: It belongs to the suite of ISO dentistry standards developed under ISO/TC 106 and is closely related to standards dealing with dental amalgam forms (ISO 24234) and other dental material standards addressing metallic materials and test methods.

Q: What are the key keywords?

A: dental amalgam, pre‑capsulated, capsule, mercury, alloy powder, dental materials, packaging, labelling, test methods.