Product certification
86
7990087_030_03 – 2080492 – 2023-01-19
12.4 SVHC (Substance of very high concern)
According to Article 33 of the REACH Regulation (EC) no.
1907/2006, the following products may contain components with
reportable substances in concentrations exceeding
0.1 mass percent. A list of affected components will be provided
by Baxter on request. The list can also be seen on the Internet at
ois.hillrom.com/ois.
13 Product certification
13.1 European Union
The surgical light is a Class I medical device according to
Regulation 2017/745/EU concerning medical devices, and is
compliant with the version of this regulation in force at the time of
product sale. Baxter declares the conformity of the surgical light
with the essential safety and performance requirements
according to Regulation 2017/745/EU concerning medical
devices, Annex I. A conformity assessment procedure required for
Class I devices shall be carried out in accordance with Article 52
(7), taking into account a quality management system in
accordance with Annex IX, Chapter 1. Baxter certifies conformity
by means of the CE marking.
The Trumpf Medical Wifi module, the Mobile Control 7,9 and the
Wall Control Panel comply, under normal use, with the
requirements of Directive 2014/53/EU regarding radio systems.
The declaration of compliance can be requested using the contact
details below.
13.2 USA/Canada
The surgical light was tested for the USA and Canada by
Underwriter Laboratories Inc. UL/cUL classification with respect to
electric shock, fire and mechanical hazards in accordance with
UL 60601-1, 1st Edition, 04-26-2006 and, ANSI/AAMI ES60601-1:
2005/AMD1:2012 and CAN/CSA-C22.2 No. 60601-1:2014.
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