ISO 4823-2025 PDF

Full title and description

ISO 4823:2025 — Dentistry — Elastomeric impression and bite registration materials. This International Standard specifies requirements and the associated test methods for elastomeric dental impression materials and bite-registration materials used in clinical and laboratory dental procedures.

Abstract

This document defines classification, physical and performance requirements, and test methods for elastomeric impression and bite registration materials (including parameters such as working time, setting time, dimensional stability, detail reproduction, elastic recovery and strain-in-compression). It provides requirements for packaging, labelling and information to be supplied by the manufacturer. The standard does not itself provide biological hazard limits; users are directed to ISO 7405 and the ISO 10993 series for biocompatibility assessment.

General information

• Status: Published (International Standard).
• Publication date: June 2025 (published 19 June 2025; corrected version issued August 2025).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.060.10 (Dentistry).
• Edition / version: Edition 6 (2025).
• Number of pages: 33 pages (main publication).

Key bibliographic details above are based on the ISO bibliographic record and published metadata for ISO 4823:2025.

Scope

ISO 4823:2025 applies to elastomeric dental impression materials and bite-registration materials intended to produce reproductions of oral tissues for diagnostic, prosthetic and restorative procedures. The standard covers classification by consistency (types 0–3 and type B for bite registration), performance requirements and standardized test methods for physical properties and handling characteristics. It does not set biological safety limits; separate biocompatibility standards should be used for that purpose.

Key topics and requirements

• Classification by consistency: Type 0 (putty), Type 1 (heavy-bodied), Type 2 (medium-bodied), Type 3 (light-bodied) and Type B (bite registration).
• Working time and setting time requirements and test methods to verify clinically relevant handling windows.
• Dimensional stability / linear dimensional change (short- and longer-term measurements).
• Detail reproduction criteria and standardized test specimens for surface detail assessment.
• Elastic recovery and strain-in-compression (to ensure impressions can be removed from the mouth without tissue injury and resist deformation during casting).
• Tear strength, hardness and related mechanical property tests relevant to handling and laboratory procedures.
• Packaging, labelling and required manufacturer’s instructions (mixing, handling, storage, shelf life and safety information).
• Compatibility with gypsum and other model-forming materials used in dental laboratories.
• Exclusion of specific biological hazard limits—refer to ISO 7405 and ISO 10993 series for biocompatibility evaluation.

These topics and the standard test methods are specified in the main body and test clauses of ISO 4823:2025.

Typical use and users

Primary users include dental clinicians (general dentists and specialists), dental laboratories, dental-material manufacturers, quality and regulatory personnel, testing laboratories and procurement teams for dental products. The standard is used to evaluate product conformity, to support specifications in tenders and regulatory submissions, and as a reference for in-house quality control and material selection.

Related standards

Relevant related standards and references commonly used alongside ISO 4823:2025 include ISO 7405 (biological evaluation of dental materials), the ISO 10993 series (biocompatibility of medical devices), and other dentistry standards dealing with materials, testing and digital workflows (for example, standards referenced in earlier editions such as ISO 12836). Users should consult the normative references section of ISO 4823:2025 for the complete list.

Keywords

elastomeric impression materials, bite registration, dental impression, polyvinyl siloxane, addition silicone, condensation silicone, polyether, dimensional stability, working time, elastic recovery, strain-in-compression, detail reproduction, dental standards.

FAQ

Q: What is this standard?

A: ISO 4823:2025 is the International Standard that specifies classification, performance requirements and test methods for elastomeric dental impression materials and bite-registration materials.

Q: What does it cover?

A: It covers consistency classification (types 0–3 and type B), handling characteristics (working and setting time), mechanical and dimensional properties (elastic recovery, strain-in-compression, tear strength, linear dimensional change), detail reproduction, compatibility with model materials, and manufacturer information/label requirements. It does not itself set biocompatibility limits.

Q: Who typically uses it?

A: Dentists, dental laboratories, manufacturers of dental impression/bite-registration materials, testing laboratories, regulatory bodies and procurement/specification writers use this standard for product assessment, compliance and selection.

Q: Is it current or superseded?

A: ISO 4823:2025 is the current published edition (Edition 6, published June 2025). It revises and replaces earlier editions including ISO 4823:2021 and prior versions. Corrected editions were issued in August 2025 where minor editorial corrections were applied.

Q: Is it part of a series?

A: ISO 4823 is part of the body of dentistry standards maintained by ISO/TC 106 (Dental medical devices) — specifically SC 2 for materials — and it cross-references other ISO dental standards for testing and safety (for example ISO 7405 and the ISO 10993 series).

Q: What are the key keywords?

A: Elastomeric impression, bite registration, dental impression materials, dimensional stability, working time, elastic recovery, detail reproduction. These reflect the principal properties and applications standardized by ISO 4823:2025.