Table of Contents
Advertisement
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. O
protection.
•
a
• ISO 14971-2019 Risk management to medical de ces.
DIRECTIVE USED
• MDR 2017/745 Annex VIII and Rule 13
• IEC 60601-1-3.1 edition (2012)
• IEC 60601-1-2-3rd edition (2014)
• EN 55011:2016
CLASSIFICATIONS
• For Europe, per MDR 2017/745, the unit is a Class I instrument, per rule 13, Annex VIII.
• For the United States, t
• Please observe all applicable accident prevention regulations.
6210000-795
tion is Class I.
Prima M
Prima Mµ
6
Issue 1.8
Printed on June.,2023
Advertisement
Table of Contents
Need help?
Do you have a question about the PRIMA Mu and is the answer not in the manual?