ISO 21563-2021 PDF
Name in English:
St ISO 21563-2021
Name in Russian:
Ст ISO 21563-2021
Original standard ISO 21563-2021 in PDF full version. Additional info + preview on request
Full title and description
ISO 21563:2021 — Dentistry — Hydrocolloid impression materials. This International Standard specifies requirements, test methods, and labelling/instruction requirements for elastic aqueous agar and alginate hydrocolloid dental impression materials intended for retail marketing.
Abstract
This document defines performance and testing requirements to determine whether agar and alginate hydrocolloid impression materials (as supplied for retail sale) meet the quality necessary for their intended dental impression purposes. It includes test methods and requirements for labelling and instructions for use, and explicitly excludes assessment of biological hazards (see ISO 7405 and the ISO 10993 series for biocompatibility guidance).
General information
- Status: Published
- Publication date: 31 August 2021
- Publisher: International Organization for Standardization (ISO)
- ICS / categories: 11.060.10 (Dental materials)
- Edition / version: Edition 2 (2021)
- Number of pages: 46
Scope
ISO 21563:2021 specifies the requirements and test methods for hydrocolloid impression materials — specifically elastic aqueous agar and alginate materials — as prepared for retail marketing. The standard addresses material properties, dimensional stability and accuracy-related tests relevant to clinical impression-taking, as well as labelling and instructions for safe and effective use. It does not address biological hazard assessment or biocompatibility, which are covered by ISO 7405 and the ISO 10993 series.
Key topics and requirements
- Definitions and classification of hydrocolloid (agar and alginate) dental impression materials.
- Material property requirements (e.g., viscosity, working and setting times, elastic recovery).
- Dimensional stability and accuracy test methods for impressions and casts.
- Instructions for use and mandatory labelling elements for products supplied for retail.
- Sampling, specimen preparation and standardized test procedures to verify conformity.
- Exclusion of biological hazard/biocompatibility testing from scope (references to ISO 7405 and ISO 10993 series).
Typical use and users
Used by dental materials manufacturers (quality and regulatory teams), dental laboratories, clinical prosthodontists and dentists involved in impression material selection, as well as testing laboratories and conformity assessment bodies verifying product compliance for market placement.
Related standards
Notable related standards and references include ISO 7405 (evaluation of dental materials with respect to biological effects), the ISO 10993 series (biological evaluation of medical devices), and other ISO/TC 106 standards addressing dental materials and testing methods. National/adopted versions (e.g., EN/BS adoptions) may exist for local regulatory use.
Keywords
hydrocolloid, agar, alginate, dental impression materials, dentistry, impression accuracy, dimensional stability, test methods, labelling, ISO 21563
FAQ
Q: What is this standard?
A: ISO 21563:2021 is an International Standard that specifies requirements and test methods for agar and alginate hydrocolloid dental impression materials supplied for retail marketing.
Q: What does it cover?
A: It covers material definitions, performance requirements, standardized test methods (e.g., for dimensional stability and elastic recovery), and labelling/instruction requirements. It does not cover biological hazard or biocompatibility assessment.
Q: Who typically uses it?
A: Manufacturers, dental laboratories, testing/certification bodies, dental clinicians selecting impression materials, and regulatory/quality teams responsible for product conformity and labelling.
Q: Is it current or superseded?
A: Current — ISO 21563:2021 is Edition 2 (published in 2021) and replaces the earlier ISO 21563:2013 edition.
Q: Is it part of a series?
A: It is part of ISO/TC 106 work on dentistry and is related to other standards addressing dental materials and biological evaluation (notably ISO 7405 and the ISO 10993 series), but it is a standalone product-specific standard for hydrocolloid impression materials.
Q: What are the key keywords?
A: Hydrocolloid, agar, alginate, dental impressions, dimensional stability, elastic recovery, test methods, labelling, dentistry.