6. Important safety information
Our website
has information about any safety notices to the market or recalls
of devices and accessories.
6.1. Standards met and classification
Mercado Medic's work chairs are CE
marked in accordance with the Regulation
on Medical Devices (EU) 2017/745, MDR,
and the Medical devices Agency's Code of
Statutes for Medical Devices LVFS 2003:11.
The devices are medical devices as defined
in Article 2 of the MDR. The devices are
classified as Class 1 non-invasive medical
devices in accordance with Regulation 1.
The active property of the device variants
with electrical functions is not considered to
affect the classification.
The devices are tested and approved
according to the following standards:
• EN 12182:2012
• IEC 60601-1:2005 + A1:2012
• EN 60601-1-2:2015
• EN 60601-1-11:2015 + A1:2020
• EN 1335-1:2000
• EN 1335-2:2009
• EN 1335-3:2009
The following standards have also been used
in the development of the devices:
• EN 1041:2008 + A1:2013
• EN ISO 14971:2020
All textiles on the devices have been tested
and approved according to the following fire
protection standards:
• EN 1021-1:2014 (ignition source: lit
cigarette)
• EN 1021-2:2014 (ignition source: gas
flame equivalent to a burning match)
Only the underside of the seat and armrests
do not have fire protection as they are
wooden. All other surfaces are made of
metal or clad in fire protection-rated textiles.
Armrests, seats, backrests, etc. have been
developed and designed to be free from toxic
substances and allergens.
Models with electrical functions are
classified according to IEC 60601-1:2005 as
a medical device with applied part (Applied
Part as defined in standard) of type B
associated protection class II with internal
power source.
Models with electrical functions meet
protection class IP21. The first digit (2)
covers contact protection for fingers, etc.,
preventing access to hazardous parts with
fingers or similar. The second digit (1) means
vertical drip protection, and so the device
can therefore withstand light showers from
above.
36
Instructions for use for medical work chairs in the REAL 9000 PLUS device range
Important safety information
21-08742-EN-01
Summary of Contents for REAL 9000 PLUS Series
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