基本信息
文件名称：Bacro巴可医疗显示器 Coronis OneLook (MDMC-32133) MDR UKCA Declaration of Conformity MDSC-8527 SSTP, MDSC-8527, MDSC-8527 SSTF, MDSC-8527 NXF, MDSC-8527 SSTF M2.pdf
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更新时间：2025-05-26
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文档摘要

UKCA

DECLARATIONOFCONFORMITY

Kortrijk,07March2025

ManufacturerIdentification:

LegalName:BarcoNV

Address:PresidentKennedypark35

8500Kortrijk,Belgium

UKresponsibleperson:BarcoUKLtd

Address:Building329,DoncastleRoad

BracknellRG128PE,Berkshire,UnitedKingdom

ProductIdentification:

Product:MedicalDisplay

Brand:Barco

Model:MDSC-8527

Typenumbers:MDSC-8527SSTP;MDSC-8527SSTF,MDSC-8527NXF,

MDSC-8527SSTFM2

Declaration:

Providedthatitisinstalled,maintainedandusedintheapplicationforwhichitismade,with

respectoftheprofessionalpractices,relevantinstallationcodesandmanufacturer’sinstructions:

Weherebydeclare,underoursoleresponsibility,thattheabovereferencedproductisin

conformitywiththerelevantStatutoryInstruments(andtheiramendmentsifapplicable)

MedicalDevicesRegulations2002?(SI2002No618,asamended)(UKMDR2002)

and2012No.3032(RoHS2012)

TheproceduresofAnnexVIIhavebeenappliedtoaffixtheUKCAmarkingtotheproduct.

Standardsapplied:

EMC:EN60601-1-2:2015

Productsafety:EN60601-1:2006+A11:2011+A1:2013+A12:2014

Softwarelifecycle

processes:EN62304:2006+AC:2008

Usabilityengineering:EN62366:2008

EN60601-1-6:2010+A1:2015

RiskManagement:ENISO14971:2019+A11:2021

Informationandsymbols:ENISO15223-1:2016

RoHS:ENIEC63000:2018