1. Introduction
vatech A9 (Model: PHT-30CSS)
Installation Manual
9
En
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1.5
Standards and Regulations
Standards
vatech A9 (Model: PHT-30CSS)
is designed and developed to comply with the
following international standards and regulations:
MEDICAL - APPLIED ELECTROMAGNETIC RADIATION EQUIPMENT
AS TO ELECTRICAL SHOCK, FIRE, AND MECHANICAL HAZARDS ONLY BY
ANSI/AAMI ES60601-1 (2005) + AMD 1 (2012),
CAN/CSA-C22.2 No. 60601-1 (2014), IEC 60601-1-3 (2008), IEC 60601-2-63
(2012)
21 CFR 1020.30, 31, 33
NEMA Standard publication PS 3.1-3.18
This is Class IIb equipment and obtained CE marking in
April 2007 for regulations compliance by the revised
European Union’s MDD (Medical Devices Directive)
93/42 EEC.
This equipment received the UL certification mark by
ANSI/AAMI, CAN/CSA-C22.2 No. 60601-1 regulations.
Classifications (IEC
60601-1 6.1)
The degree of protection against water ingress: Ordinary Equipment: IPX0
The degree of protection against electric shock: Class 1 equipment, Type B
Applied Parts: Temple Supports, Chinrests, and Bites.
