BS EN ISO 21563:2021

What is ISO 21563 about?  

ISO 21563 is one of a series of documents that outlines dentistry and specifies the requirements and test methods for hydrocolloid impression materials. This document helps to determine whether elastic aqueous agar and alginate hydrocolloid dental impression materials, as prepared for retail marketing, are of the quality needed for their intended purposes. It also specifies requirements for labelling and instructions for use.  

Note: ISO 21563 does not address possible biological hazards associated with the materials. Assessment of these hazards is addressed in ISO 7405 and the ISO 10993 series. 

Who is ISO 21563 for? 

ISO 21563 is applicable to- 

• Dentists 
• Manufacturers of Hydrocolloid impression materials 
• Manufacturers of dental devices  

Why should you use ISO 21563? 

Hydrocolloid impression materials are the first impression materials available to the dentist when mixed they form a viscous liquid that can be seated over oral structures. 

ISO 21563 outlines the pre-test planning approaches, test methods, and requirements for labelling and instructions for use which ensures elastic aqueous agar and alginate hydrocolloid dental impression materials, as prepared for retail marketing, are of the quality needed. 

What’s changed since the last update? 

BS EN ISO 21563:2021 supersedes ISO 21563:2021, which has been withdrawn. BS EN ISO 21563:2021 has some technical changes with respect to ISO 21563:2021, these include: 

• The detailed reproduction before and after disinfection for alginate powder and paste/paste materials has been corrected to be 50 microns 
• The elastic recovery test has been modified to allow for the use of poly (methyl methacrylate) plates as an alternative to glass or metal 
• Figures A.2, A.3, A.4, and A.6 have been corrected 
• Multiple editorial changes have been made throughout the document