Standards, Directives And Regulations; Standard Compliance - Storz C-MAC 8403 Serie Gebrauchsanweisung

13 Standards, directives and regulations

13.1 Standards, directives and regulations
According to Medical Device Directive (MDD):
Class I medical devices. These medical devices bear the CE mark in accordance with the
Medical Device Directive (MDD) 93/42/EEC.

13.2 Standard compliance

(for 8403 AX, BX, HX, AXC, BXC, DXC, EXC, GXC, KXC, MXC, HXP, X, XD, ZX)
Complies with EN 60601-1, EN 60601-2-18, UL 2601, CSA 601.1:
– Provides Type BF protection when used in conjunction with a KARL STORZ camera
control unit with a BF symbol on the connection port.
®
Instruction For Use • C-MAC Video Laryngoscope 8403xxx and Connection Cable 8403X • 96076019D • V4.3
Standards, directives and regulations
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