Back

EVS-EN ISO 21563:2021

Dentistry - Hydrocolloid impression materials (ISO 21563:2021)

General information
Valid from 01.10.2021
Base Documents
ISO 21563:2021; EN ISO 21563:2021
Directives or regulations
None

Standard history

Status
Date
Type
Name
01.10.2021
Main
07.10.2013
Main
This document 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. This document does not address possible biological hazards associated with the materials. Assessment of these hazards is addressed in ISO 7405 and the ISO 10993 series.
*
*
*
PDF
31.72 € incl tax
Paper
31.72 € incl tax
Browse standard from 2.44 € incl tax
Standard monitoring

Customers who bought this item also bought

Main

EVS-EN ISO 10993-9:2021

Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019)
Newest version Valid from 15.10.2021
Main

EVS-EN ISO 10993-23:2021

Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)
Newest version Valid from 15.04.2021
Main

EVS-EN ISO 17664-1:2021

Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices (ISO 17664-1:2021)
Newest version Valid from 16.09.2021
Main + amendment

EVS-EN ISO 13485:2016+A11:2021

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
Newest version Valid from 16.09.2021