EC RECOMMANDATIONS for medical equipment
Milesman Premium holds CE 0120 certification, relative to medical equipment.
Medical equipment complying to this standard must be produced in accordance with certain essential conditions specified in applicable directives, and in accordance with the individual laws of each country. This procedure applies to the evaluation of quality processes and encompasses all types of medical equipment. It guarantees:
Security, which means:
- Analyzing and evaluating risks
- Lessening adverse reactions
- Guaranteed biocompatibility
- Guaranteed electrical and mecanical safety
- Allows or forbids the combination of different products
- Complete and detailed control over security processes, and instruction manuals
Use and benefits
- Compliance with specific properties of the product
- Ensured therapeutic benefits
- Infection and pollutant prevention
- Clinical evaluations of medical equipment
- Certified measurement exactitude
Supervision
- Of manufacturer
- Of medical equipment, for the duration of product life.
Notified entities – independent auditors, testing institutes for product and quality systems verification - as well as competent authorities, oversee that all of the appropriate conditions are fulfilled.
