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EN ISO 11143:2008

Current

Current

The latest, up-to-date edition.

Dentistry - Amalgam separators (ISO 11143:2008)

Published date

01-07-2008

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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Classification
5 Requirements
   5.1 Efficiency
   5.2 Warning system for collecting container
   5.3 Alarm system for collecting container
   5.4 Alarm system for malfunction of amalgam separator
   5.5 Removal of removable filled collecting container
   5.6 Maximum fillable volume of the removable collecting
        container
   5.7 Electrical safety
6 Sampling
7 Test apparatus
   7.1 Set-up of test
   7.2 Installation of amalgam separator
8 Test sample
   8.1 Preparation of test sample
   8.2 Particle fraction
   8.3 Mass of dry test sample
   8.4 Particle fraction size distribution
   8.5 Preparation of test slurry
        8.5.1 Reagents
        8.5.2 Apparatus
        8.5.3 Procedure
9 Test method
   9.1 General
   9.2 Preconditioning
   9.3 Efficiency test
   9.4 Number of tests
   9.5 Calculation of efficiency
   9.6 Determination of efficiency
   9.7 Test of warning system for removable collecting container
   9.8 Test of alarm system for removable collecting container
   9.9 Test of alarm system for malfunction of amalgam separator
   9.10 Removal of filled collecting container
   9.11 Maximum fillable volume of the removable collecting container
   9.12 Electrical safety
10 Test report
11 Manufacturer's instructions for installation, use, maintenance
   and service
12 Marking
   12.1 General
   12.2 Marking of amalgam separator
   12.3 Marking of liquid inlet and outlet of the amalgam separator
   12.4 Marking of removable collecting container
Annex A (informative) Preparation of amalgam test sample
Annex B (informative) Procedure for grinding the hardened amalgam
Annex C (informative) Examination of particle fraction 3 using
        sedimentation with X-ray absorption
Annex D (informative) Particle fraction size distribution of
        amalgam in dental waste water
Bibliography

ISO 11143:2008 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, instructions for use, operation and maintenance.All tests described in ISO 11143:2008 are type tests.

Committee
CEN/TC 55
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Current

DIN EN 1640:2010-02 Dentistry - Medical devices for dentistry - Equipment
BS EN 1640:2009 Dentistry. Medical devices for dentistry. Equipment
I.S. EN 1640:2009 DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - EQUIPMENT
UNI EN 1640 : 2010 DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - EQUIPMENT
02/563818 DC : DRAFT SEP 2002 BS EN 1640 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - EQUIPMENT
EN 1640:2009 Dentistry - Medical devices for dentistry - Equipment
08/30184608 DC : DRAFT SEP 2008 BS EN 1640 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - EQUIPMENT

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