Download Print this page

Labomed PRIMA Pro User Manual page 37

Operating surgical microscopy

Advertisement

14. STANDARDS AND DIRECTIVES
The instrument described in this user manual has been designed in compliance with the following
standards:
ISO 8600-3 First edition 1997-07-01 AMENDMENT 1 Optics and Optical instruments - Medical
endoscopes and endoscopic accessories Part 3: Determination of field of view and direction of view of
endoscopes with optics.
ISO 8600-5 First edition 2005-03-15 Optics and phonetics-Medical endoscopes and endotherapy
Devices. Part 5: Determination of field of view and direction of view of endoscopes with optics.
ISO 8600-5 First edition 2005-03-15 Optics and phonetics-Medical endoscopes and endotherapy devices
Part 5: Determination of optical resolution of rigid endoscopes with optics.
ISO 13485 quality management systems approved by UL.
ISO 14971 Risk management to medical devices.
DIRECTIVE USED
MDR 2017/745 Annex VIII and Rule 13
IEC 60601-1-3.2
IEC 60601-1-2-4.1 ed.
EN 55011:2007
CLASSIFICATIONS
For Europe, per MDR 2017/745, the unit is a Class I instrument, per rule 13, Annex VIII.
For the United States, the FDA classification is Class I.
Please observe all applicable accident prevention regulations.
6182001-795
Prima Pro
Issue 1.0
Printed on Jan, 2024

Advertisement

loading
Need help?

Need help?

Do you have a question about the PRIMA Pro and is the answer not in the manual?

This manual is also suitable for:

618360161836026183603