MAGNA
12. STANDARDS AND DIRECTIVES
6129000-795
Magna
Issue 1.7
Printed on May,2020
32
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 8600-3 First edition 1997-07-01 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 photonics-Medical endoscopes and endotherapy devices
Part 5: Determination of optical resolution of rigid endoscopes with optics.
•
ISO 9001/13485 and USFDA 21 CFR 820 Quality management systems approved by UL.
•
ISO 14971 Risk management to medical devices.
DIRECTIVE USED
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Directives 93/42/EEC, Article II, Section 5, Annex VII.
•
IEC 60601-1-3rd edition (2005)
•
IEC 60601-1-2
•
EN 55011:2007
CLASSIFICATIONS
•
For Europe, per Directive 93/42/EEC, the unit is a Class I instrument, per rule 12, Annex IX.
•
For the United States, the FDA classification is Class I.
•
Please observe all applicable accident prevention regulations.
