Standards, directives and regulations
Instruction For Use • C-MAC
®
video laryngoscope 8401xxx, Electronic Module 8401/8402 X, C-MAC
®
PM 8401
XD • 96076011EN-US • V3.1
28
11 Standards, directives and regulations
11.1 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.
11.2 Standard compliance
(for 8401 AX, BX, HX, AXC, BXC, DXC, GXC, KXC, HXP, X, XD, ZX, for 8402 X/ZX, 8403 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.
– Type of protection against electric shocks: Protection Class II (does not apply to 8401 XD)
According to IEC 60601-1-2:
Please read the electromagnetic compatibility information in chapter 16 [ 35].
Additional standards:
(for 8401 AX, BX, HX, AXC, BXC, DXC, GXC, KXC, HXP, X, ZX, for 8402 X/ZX)
DO-160F, EMI Test Report (DRF Luftrettung)
(for 8401 AX, BX, HX, AXC, BXC, DXC, GXC, KXC, HXP, X, XD, ZX for 8402 X/ZX)
for 8402 X/ZX)
MIL-STD-461F (Fixed Wing)
(for 8401 XD)
DO-160F
