Midmark Preva - Compliance with Applicable Standards

Preva Dental X-ray System User Manual, 00-02-1576, Revision ZA1
11
Compliance with Applicable S t a n d ar d s
The following regulatory documents a pp ly
Radiation
Protection
The certified components of the Preva Dental X-ray System comply with Radiation
Performance Standards 21 CFR, Subchapter J, at the time of manufacture.
The certified components of the Preva Dental X-
ray System comply with IEC
60601-1-3 Radiation protection/X-ray equipment.
UL 2601-1
File Number:
E181750
Classified by Underwriters Laboratories Inc. with respect to electrical shock, fire
and mechanical hazards only in accordance with UL 2601-1, and CAN/CSA C22.2
NO, 601.1-M90, and to the following particular standards, IEC 60601-2-7, IEC
60601-2-28.
General
Safety
IEC 60601-1:1995
Medical device risk classification – Class II (FDA)
Protection against electrical shock – Class I (IEC 60601)
Degree of protection against electrical shock
Type B applied part – Pass (UL)
Type BF applied part (ClearVision sensor only) – Pass (UL)
Degree of protection against ingress of water (ClearVision sensor only) – IP67
Not suitable for use in the presence of flammable anesthetic mixture with air or
with oxygen or nitrous oxide.
EMI/EMC
IEC 60601-1-2:2007
Degree of
Protection
IEC 60529:2001
Degree of protection against ingress of water (ClearVision sensor only) – IP67
Imaging
Performance
IEC 61223-3-4:2000
Line pair resolution – better than 8 lp/mm
Low contrast resolution – all holes visible