Standards; Product Description - MAVIG RP270 Gebrauchsanweisung

5.0 Specifications
5.3.1 Standards RP and RD Products
CE marking
With this symbol MAVIG declares that the products comply with the provisions in the applicable
EU directives. Conformity is indicated on the label by the CE mark with the four-digit identification
number of the notified body.
MAVIG declares that the products are in conformity with IEC 61331-1:2014, DIN EN 61331-1:2016,
IEC 61331-3:2014, DIN EN 61331-3:2016, the German X-ray Ordinance (RöV), the Regulation
(EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective
equipment and repealing Council Directive 89/686/EEC (published in the Official Journal of the
European Union, L81, 31 March 2016), and the Regulation (EU) 2017/745 of the European Parliament
and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation
(EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC
and 93/42/EEC. MAVIG is DIN EN ISO 13485:2016 certified.
The EC-type examination was conducted by:
Identification number of the notified body:
The Declaration(s) of Conformity of personal protective equipment can be found under the
following link: www.mavig.com/company/conformity
5.3.2 Standards ST-FS, ST-RZ, and ST-ER Products
CE marking
With this symbol MAVIG declares that the products comply with the provisions in the applicable
EU directives.
MAVIG declares that the products are in conformity with IEC 61331-1:2014, DIN EN 61331-1:2016,
and the Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017
on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation
(EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. MAVIG is DIN EN
ISO 13485:2016 certified.
5.4

Product Description

Personal protective equipment - radiation protective clothing - is mandatory for operators/
users of systems that use X-rays for diagnostics or therapy, and thereby serves to protect
against ionizing radiation.
Standards / Product Description
0302
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