Polytel
®
GMA2
9-2520-3
October 2016
22
•
In Vitro Diagnostic Medial Devices Directive 98/79/EC
•
Restriction of the use of certain hazardous
substances in electrical and electronic equipment
2011/65/EU
The following standards have been applied in its design
and manufacture:
•
EN 300 328 V1.7.1
•
EN 301 489-1 V1.9.2
•
EN 301 489-17 V2.2.1
•
EN 61326-1: 2006
•
EN ISO 13485:2012
•
ISO 13485/8 under Canadian Medical Device
Conformity Assessment System (CMDCAS)
• EN
50581:2012
• 4.4 About the label at the
bottom of the GMA
The label on the side of your GMA shows the unique ID
number (serial number) of your device as well as some
other things you might need to know:
Seal/Mark
Meaning
The device complies with all
applicable EU directives that
require the affi xing of this mark.
You should read accompanying
documents before use.
