Standard And Directives Applicable - Labomed PRIMA GN User Manual

Colposcope

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5. 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 endo-

scopes 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 14971-2007 Risk management to medical devices.

DIRECTIVE USED

• MDR 2017/745 Annex VIII And Rule 13

• IEC 60601-1-3rd edition (2005)

• IEC 60601-1-2

• 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 II 510K exempted

• Please observe all applicable accident prevention regulations.

6165000-795

Prima GN

PRIMA GN

Issue 1.9

Printed on May,2023

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