The Spanish Association for Standardization, UNE, yesterday recognised the Spanish Federation of Healthcare Technology (FENIN) for its commitment and involvement in standardisation activity.
Margarita Alfonsel, General Secretary of FENIN was awarded the commemorative plaque by Paloma Garcia, Director of UNE's Standardisation Programmes and Interest Groups, during the 25th Meeting on Healthcare Technology, held in Barcelona on 12 June. The event was organised by FENIN and the academic institution ESADE.
FENIN, a corporate member of UNE since 1990, is very committed to standardisation activity and actively participates in the development of standards that support its competitiveness and assist with its legal compliance. FENIN manages the secretariat of six Technical Standardisation Committees: Surgical implants (TC 91); Dentistry (TC 106); Breathing attachments and anaesthetic machines, (TC 110); Medical and surgical instruments (TC 111); Clinical laboratory testing and in vitro diagnostic test systems (TC 129) and Technical systems and aids for disabled or handicapped persons (TC 153).
These committees are mainly responsible for developing standards for healthcare products: including electro-medical equipment, needles and aerosols, as well as surgical instruments, gloves and prosthesis.
Some highlights, among other standards led by FENIN, are
UNE-EN-ISO 13485 that establishes the requirements of a quality management system for healthcare products with statutory obligations; the Standard UNE-EN ISO 14971 Healthcare products. Aplicación de la gestión de riesgos a los productos sanitarios o la serie de normas
UNE-EN ISO 10993 on the Biological evaluation of medical devices.
The healthcare sector has more than 900 UNE standards that support its competitiveness, as well as the quality and safety of its products and services. In addition, the standards help in maintaining healthcare law compliance.