International Norms


ISO 13485:2016; EN ISO 13485:2016. Health Products. Quality Management Systems. Requisites for regulation purposes, encompassing good manufacturing practices.

Legislation:
European:
Directive 98/79/EC, 27October, concerning health products for in vitro diagnosis.
Spanish:
Royal Decree 1662/2000, 29 September, HEALTH PRODUCTS FOR "IN VITRO" DIAGNOSIS

System Quality Management

ISO 13485:2016 / EN ISO 13485:2016 Health Products. Quality management systems. Requirements for regulatory purposes.

  ISO 2020 - 2023

Valid from 04 January 2020 until 03 January 2023