YY 0715-2009Dentistry - Amalgam capsules (English PDF)

Foreword

All technical contents of this standard is mandatory.

This standard is identical with ISO 13897:2003 "Dentistry Amalgam Capsule" and Technical Corrigendum. This standard is based on ISO 13897:2003 redrafted.

This standard relates to silver amalgam capsules suitable for dental clinical treatment.

This standard does not include the possible biological hazards qualitative and quantitative requirements, but it is recommended in the evaluation of possible biological hazards, the use of YY/T 0268 "Dentistry Oral Biological evaluation of medical devices Module 1. Evaluation and testing."

Introduction

For the production of dental amalgam, dental amalgam reconcile electric device YY/T 0273-1995 described mainly used for mixing dental silver alloy Powder and dental mercury. Many dental amalgam to reconcile the use of a removable capsule-contained dental dental silver alloy powder and mercury. Although the use and When testing the capsule should be considered as dental amalgam reconcile the parts, but in the YY/T 0273-1995 did not relate to the capsule begging. These requirements are the subject of this standard. Dentistry amalgam capsules

1 Scope

This standard specifies the pre capsule for mixing silver alloy powder and mercury and requirements and test methods for reusable capsules.

2 Normative references

The following documents contain provisions which, through reference in this standard and become the standard terms. For dated references, subsequent Amendments (not including errata content) or revisions do not apply to this standard, however, encourage the parties to the agreement are based on research Whether the latest versions of these documents. For undated reference documents, the latest versions apply to this standard.

GB/T 6387-1986 Dental Materials Terminology

GB/T 7408-2005 data elements and interchange formats - Information interchange dates and times (ISO 8601:2000, IDT)

YY/T 0273-1995 dental amalgam harmonic filter (eqv ISO 7488:1991)

ISO 24234:2004 Dentistry - Dental amalgam alloy powder of silver and mercury

3 Terms and Definitions

GB/T 6387, YY/T 0273-1995 and ISO 24234:2004 and established the following terms and definitions apply to this standard.

4 Products

This standard amalgam mixing capsule according to whether reusable, divided into the following types.

--- Type 1. single-use capsule;

--- Type 2. reusable capsules.

5 Requirements