DECLARATION OF CONFORMITY
EU EMC Directive 2014/30/EU
The Low Voltage Directive 2006/95/EG
Medical Devices Directive 93/42/EEC
Manufacturer
Shire Controls Ltd
Studio 3 Channocks Farm,
Gilston, Harlow
Essex CM20 2RL
United Kingdom
Product Type
SDX-15 Plant Alarm System
Includes
SDX-15 Plant Alarm
SDX-15 Remote & Internal Transmitter
SDX-15 Plant To Alarm Interface
SDX-RTX1 Transmitter
SDX-15 Interfaces
Year of manufacture
2021
Standards used
To which this declaration relates is in
conformity with the following standards:
EN60601-1-2 4th Edition 2015
Emissions Standard for Medical Equipment
EN55011, Class A 2016 + A1:2017
Emissions Standard for ISM Equipment
EN60601-1-2 4th Edition 2015
Immunity Standard for Medical Equipment
EN61000-4-2 2009
ESD Requirements
EN61000-4-3 2006 + A1 + A2
Radiated Susceptibility
EN61000-4-4 2016
Electrical Fast Transient Burst Requirement
EN61000-4-5 2017
Surges Requirements
EN61000-4-6 2014
Conducted Susceptibility
EN61000-4-8 2012
Magnetic Field Immunity
EN61000-4-11 2017
Voltage Dips and Interruptions
Authorised representative
Technical Director
Signature
10
Shire Controls Ltd
Studio 3, Channocks Farm
Gilston
Harlow
Essex
CM20 2RL
Tel. (01279) 434399
www.shirecontrols.com