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FLOW CYTOMETRY CATEGORIES PRODUCTS
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
Valid from 04 January 2020 until 03 January 2023