Standard And Directives Applicable - Labomed PRIMA Mm User Manual

5. STANDARDS AND DIRECTIVES
The instrument described in this user manual has been designed in compliance with the following standards:
• ISO 15004-2 First edition 2007-02-15. Ophthalmic instruments and test methods. Part 2: light hazard
protection.
• ISO 9001/13485 quality management systems approved by UL(notified body).
• ISO 14971-2007 Risk management to medical devices.
DIRECTIVE USED
• MDR 2017/745 Annex IX and Rule B
• Directives 93/42/EEC, Articles II, Section 5, Annex VII.
• IEC 60601-1-3.1 edition (2012)
• IEC 60601-1-2-4th edition (2014)
• EN 55011:2016
CLASSIFICATIONS
• For Europe, per MDR 2017/745, the unit is a Class I instrument, per rule 13, Annex IX.
• For the United States, the FDA classification is Class I.
• Please observe all applicable accident prevention regulations.
6210000-795
Prima Mµ
PRIMA Mu
6
Issue 1.6
Printed on Jan.,2021