Manufacturer’s
proficiency
High product self-responsibility, future-oriented developments, safety
due to controlled quality, and professional on-the-spot support –
benefit from our competence.
Development in compliance with standards
Heimerle + Meule dental alloys compounds have been designed to meet
optimum biological compatibility. In compliance with the requirements,
all dental alloys by Heimerle + Meule have been developed and tested
according to the following standards:
| - DIN EN ISO 9693 |
- |
dental restorative metal-ceramic-systems |
| - DIN EN ISO 22674 |
- |
dentistry - metallic materials for fixed and removable dentures |
| - DIN EN ISO 9333 |
- |
dental solders |
Biological compatibility
The biological compatibility of Heimerle + Meule’s
dental alloys has been analysed in close co-operation
with independent testing institutes. The following
test procedures have been employed:
• Cytotoxicity analysis: growth-inhibition-test
• according to ISO 10993-5
• Sensitisation analysis: analysis on irritations
• and sensitisation according to ISO 10993-10
• Corrosion analysis: static immersion test according
to ISO/CD 10271
• Metal ions analysis in DMEM elution
Discharge of metal ions resulting from the corrosion analysis
was below the recommended limit value. As result from the
Cytotoxicity analysis, the dental alloys do not hold any
cytotoxic potential. No skin irritation or allergic sensitisation
could be ascertained.
Controlled quality
Each melted alloy is analysed batch by batch with regard
to its chemical composition and purity and the results are
documented. This guaranties consistent quality on the highest
level.
The analysis is carried out using spectroscopic methods
(ICP = Inductive Coupled Plasma, AAS = Atom-Absorption-Spectroscopy).
Analysis of the thermal properties, the strength properties,
as well as structure analysis complete the test procedure.
The batch number printed on every package ensures traceability.
Certified QM Systems
Dental alloys are subject to the requirements of the Medical
Products Regulations (MPG = German Law) and the European
Directives 93/42/EWG on medical products.
With the high quality standard and the proven biocompatibility
of their dental alloys, Heimerle + Meule meet these most
stringent regulations. All dental alloys by Heimerle + Meule
have the CE mark which is required for medical products
within the European Union since 1998.
The quality management system for development, production,
and distribution of dental alloys is certified in accordance
with DIN EN 13485 for medical products, while the whole-company
quality management system corresponds to DIN EN ISO 9001. |
