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.
Who uses this standard
- Dental equipment manufacturers and R&D teams
- Test laboratories and conformity assessment bodies
- Dental clinic managers, procurement officers and facility engineers
- Environmental regulators and waste management professionals
- Standards bodies and compliance auditors
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.
