Standards And Regulations - Vatech PHT-30CSS Installation Manual

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

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.
vatech A9 (Model: PHT-30CSS)
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.
Installation Manual
1. Introduction
9