ISO 11143-2008 PDF

Full title and description

St ISO 11143-2008 — Dentistry — Amalgam separators. This International Standard specifies requirements and laboratory test methods for amalgam separators used with dental equipment, including performance (retention efficiency), safe functioning, marking, instructions for use, operation and maintenance.

Abstract

ISO 11143:2008 defines type-test procedures and minimum requirements for the design and performance of amalgam separators intended to collect amalgam particles and reduce mercury discharge from dental wastewater. The standard establishes a laboratory test for separator efficiency and sets requirements for safe operation, marking and user documentation.

General information

• Status: Published (International Standard, confirmed).
• Publication date: 2008 (edition 2, published mid-2008; ISO listing shows publication July 2008 / edition 2.0 2008).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.060.20 — Dental equipment (dentistry).
• Edition / version: Edition 2 (ISO 11143:2008), superseding ISO 11143:1999.
• Number of pages: International edition: 25 pages (published ISO edition). National/adopted versions (for example BS EN) may show longer pagination due to national forewords/annexes.

Scope

ISO 11143:2008 applies to amalgam separators intended for installation on dental equipment drainage systems. It covers mechanical and hydraulic designs used to separate amalgam particles from wastewater, specifies the laboratory test method used to determine retention efficiency, and sets out requirements for safe functioning, marking, instructions for operation and maintenance. The standard applies to type testing (laboratory tests), not to routine in-service monitoring.

Key topics and requirements

• Definition and classification of amalgam separators and related components.
• Type-test method for determining amalgam retention efficiency (laboratory particle challenge and measurement procedure).
• Performance criteria for retention efficiency expressed as percentage retention of amalgam particles of specified size distribution.
• Requirements for safe operation, installation considerations and interaction with dental suction/wastewater systems.
• Marking, information supplied by the manufacturer, and instructions for use, operation and maintenance.
• Test reporting and documentation for type approval.

Typical use and users

Primary users are dental equipment manufacturers, dental clinics and hospitals, laboratory testers, certification bodies, environmental regulators and procurement teams specifying wastewater-control equipment for dental practices. The standard is used to evaluate and compare amalgam separators for compliance with minimum retention and safety requirements and to support purchasing and regulatory compliance.

Related standards

Relevant related standards and documents include earlier ISO 11143:1999 (withdrawn and replaced by the 2008 edition), and other dental equipment standards covering dental units, suction/wastewater systems and test methods (for example standards in the ISO/TC 106 series and national/adopted EN versions such as BS EN ISO 11143:2008). Standards for wastewater handling, environmental limits and local regulations should be consulted in parallel.

Keywords

amalgam separator; dental amalgam; mercury; dental wastewater; retention efficiency; type test; marking; instructions for use; dental equipment; ICS 11.060.20.

FAQ

Q: What is this standard?

A: ISO 11143:2008 is an International Standard for dentistry that specifies requirements and test methods for amalgam separators used on dental equipment to reduce amalgam (and therefore mercury) discharge into wastewater.

Q: What does it cover?

A: It covers the laboratory (type) test for measuring amalgam retention efficiency, minimum performance and safety requirements, and requirements for marking and user documentation. It does not cover routine in-service monitoring procedures.

Q: Who typically uses it?

A: Manufacturers of amalgam separators, testing laboratories, dental clinics and institutions, procurement specialists, conformity assessment bodies and environmental/regulatory authorities.

Q: Is it current or superseded?

A: ISO 11143:2008 is the second edition published in 2008 and replaced ISO 11143:1999; the 2008 edition is listed as published/confirmed by ISO. Users should check national adoptions and any subsequent reviews or amendments in their jurisdiction.

Q: Is it part of a series?

A: It is part of the body of ISO dental equipment standards maintained by ISO/TC 106 and is often published/adopted in national or regional variants (EN/BSI and others). It is commonly referenced alongside other dental equipment standards addressing patient chairs, suction and wastewater systems.

Q: What are the key keywords?

A: Amalgam separator; dental amalgam; mercury; retention efficiency; wastewater; dental equipment; test method; type test; marking; maintenance.