ISO 11143:2008 歯科 — アマルガムセパレーター | ページ 2

Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.

International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.

The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote.

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights.

ISO 11143 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 6, Dental equipment.

This second edition cancels and replaces the first edition (ISO 11143:1999) which has been technically revised by means of the following changes:

• a) the description of the test method has been improved;
• b) testing at a minimum flow rate for certain types of separator is now required;
• c) updated labelling requirement has been introduced.

Introduction

Amalgam separators are items of dental equipment designed to retain amalgam particles carried by the waste water from the dental treatment centre, so as to reduce the number of amalgam particles and therefore the mass of amalgam entering the sewage system.

Separation of the amalgam particles may be effected by the use of a centrifuge, sedimentation, filtration, or a combination of any of these methods.

It is recognised that the test sample used to assess the efficiency of an amalgam separator should have a particle size distribution which reflects the actual situation in dental treatment centres. The test sample used in this International Standard is based on investigations that have been carried out to determine the particle size distribution of amalgam particles in waste water from dental treatment centres (see Annex D).

The principle of the test is that the effluent water from the amalgam separator is collected in a vessel. The collected effluent water, containing amalgam particles not retained by the amalgam separator, is filtered through a series of preweighed filters. The filters, with the amalgam particles collected on them, are dried to a constant weight in a desiccator at room temperature and the total mass of collected particles is measured to determine the collection efficiency.

1 Scope

This International Standard specifies requirements and test methods for amalgam separators used in connection with dental equipment in the dental treatment centre. It specifies the efficiency of the amalgam separators in terms of the level of retention of amalgam based on a laboratory test and the test procedure for determining this efficiency. It also includes requirements for the safe functioning of the amalgam separator, for marking, and for instructions for use, operation and maintenance.

All tests described in this International Standard are type tests.

2 Normative references

The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.

3 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO 1942 and ISO 24234 and the following apply.

Bibliography