EN ISO 11143:2008 PDF

Name: EN ISO 11143:2008 — Dentistry - Amalgam separators (ISO 11143:2008)
SKU: EN ISO 11143:2008
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Dentistry - Amalgam separators (ISO 11143:2008)

Название (английский):

EN ISO 11143:2008

Dentistry - Amalgam separators (ISO 11143:2008)

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 34
Дата публикации:: 1 июля 2008 г.
Издание:: CEN EN 11143 edition 2 version 1
ICS:: 11.060.20

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Описание (английский):

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.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

EN ISO 11143:2008 (ISO 11143:2008) - "Dentistry - Amalgam separators" - specifies requirements and laboratory test methods for amalgam separators used with dental equipment in a dental treatment centre. The standard defines how to measure the efficiency of amalgam separators (mass percentage retention of amalgam particles) and sets requirements for safe functioning, marking, instructions for use, operation and maintenance. All tests in the standard are type tests.

Key topics and technical requirements

Efficiency testing and test method: A laboratory procedure collects effluent from the separator, filters it through pre‑weighed filters, dries to constant weight and determines retained mass to calculate separator efficiency. The test sample particle size distribution is based on actual dental wastewater (see Annex D).

Test apparatus and sampling: Detailed set‑up, installation, sampling procedures, preconditioning and number of tests required for valid results.

Test sample and slurry preparation: Procedures for preparing hardened amalgam, grinding, particle fraction sizes and slurry reagents (Annex A–C).

Performance and safety features:

Warning and alarm systems for removable collecting containers and separator malfunctions
Requirements for removal and maximum fillable volume of collecting containers
Electrical safety provisions in line with applicable IEC standards

Documentation and marking: Required manufacturer instructions for installation, use, maintenance and service, plus standardized marking of device, inlets/outlets and collecting containers.

Reporting: Mandatory elements of the test report and calculation procedures for declared efficiency.

Practical applications

Specify acceptance criteria and test protocols for product development and type testing of amalgam separators.

Provide objective, repeatable methods for third‑party testing laboratories to verify separator performance.

Help dental clinics and procurement teams evaluate and compare separators based on documented retention efficiency, safety features and maintenance requirements.

Support environmental compliance and reduction of mercury/amalgam discharge to sewage systems by validating separator performance.

Related standards (normative references)

Key referenced documents include ISO 1942 (vocabulary), ISO 24234 (mercury/alloys for dental amalgam), ISO 9687 (graphical symbols), ISO 3696 (laboratory water) and electrical safety standards IEC 60601‑1 and IEC 61010‑1.

For manufacturers and procurement professionals seeking to reduce dental wastewater mercury load, EN ISO 11143:2008 is the definitive technical reference for specifying, testing and documenting amalgam separator performance.

EN ISO 11143:2008 PDF

Abstract

Похожие стандарты

Overview

Key topics and technical requirements

Practical applications

Who uses this standard

Related standards (normative references)

Технические детали

ISO 11143:2008

Dentistry — Amalgam separators

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BS EN ISO 24234:2015

Dentistry. Dental amalgam.

ISO 9687:2015/Amd 1:2018

Dentistry — Graphical symbols for dental equipment — Amendment 1

SIST EN ISO 3696:1998

Water for analytical laboratory use - Specification and test methods (ISO 3696:1987)

IEC 60601-1:2005

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

IEC 61010-1:2010

Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General r…