Labomed PRIMA Pro User Manual page 37

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