Foreword

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This document was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 6, Dental equipment.

This second edition cancels and replaces the first edition (ISO 13897:2003) including Technical Corrigendum 1 (ISO 13897:2003/Cor.1:2003), which has been technically revised.

The main changes compared to the previous edition are as follows:

— the scope has been revised and is now restricted to dental amalgam reusable mixing-capsules;
— classification into two types has been deleted;
— labelling requirements have been updated.
— requirements for single-use capsules are now within the scope of ISO 20749:2017, these being:
- — the requirement for surface contamination of the package and the capsule for pre-capsulated dental amalgam alloy products;
- — loss of mass during mixing from single-use capsules;
- — the requirement for containers in which single-use capsules are supplied to prevent spillage of dental mercury leaking from faulty or damaged single-use capsules;
- — labelling requirements for pre-capsulated dental amalgam products;
- — manufacturer’s instructions regarding conditions of storage and the disposal of single-use capsules in pre-capsulated dental amalgam products.

BS EN ISO 13897:2018

Dentistry. Dental amalgam reusable mixing-capsules

Current

Published:

31 Mar 2018