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AUTHORIZED COMPONENT
COMPLIED EUROPEAN
STANDARDS LIST
Contact Information
For more information about our products, please visit www.transtek.cn.you can get customer
service, usual problems and customer download, transtek will serve you anytime.
Authorized European Representative:
Manufactured by:
GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD
Company:
GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD
Address:
Zone A, 5/F., Investment Building , No. 12, Huizhan East Rd., Torch
Development District, Zhongshan, Guangdong, 528437, China
Company:
MDSS - Medical Device Safety Service GmbH
Address:
Schiffgraben 41, 30175 Hannover, Germany
Authorized Component
1.please use the TRANSTEK
authorized adapter.
Complied European Standards List
Adapter
Type：UE08WCP-060100SPA
Input：100~240V，50~60Hz,400mA
Output：6V 1A
(Conforms to UL certificate)
Risk management
Labeling
User manual
General
Requirements for
Safety
Electromagnetic
compatibility
Performance
requirements
Clinical investigation
Usability
Software life-cycle
processes
ISO/EN 14971:2012 Medical devices — Application of risk
management to medical devices
EN 15223-1:2012 Medical devices. Symbols to be used
with medical device labels, labelling and information to be
supplied. General requirements
EN 1041: 2008 Medical equipment manufacturers to
provide information
EN 60601-1:2006 Medical electrical equipment - Part 1:
General requirements for basic safety and essential
performance
EN 60601-1-11: 2010 Medical electrical equipment --
Part 1-11: General requirements for basic safety and essential
performance - Collateral standard: Requirements for medical
electrical equipment and medical electrical systems used in
the home healthcare environment
EN 60601-1-2:2007 Medical electrical equipment - Part
1-2: General requirements for basic safety and essential
performance - Collateral standard:Electromagnetic
compatibility - Requirements and tests
EN 1060-1:1995+A2:2009 Non-invasive blood pressure
Part 1: General requirements
EN 1060-3:1997+A2:2009 Non-invasive blood pressure
Part 3: Supplementary requirements for electromechanical
blood pressure measuring system
EN 1060-4: 2004 Automatic Blood Pressure Monitor
overall system Interventional accuracy of the testing process
EN 60601-1-6: 2010 Medical electrical equipment -- Part
1-6: General requirements for basic safety and essential
performance - Collateral Standard: Usability
EN 62366: 2008 Medical devices - Application of usability
engineering to medical devices
EN 62304:2006+AC: 2008 Medical device software -
Software life cycle processes
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